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8-K - 8-K - LANNETT CO INCa16-20666_28k.htm

Exhibit 99.1

 

GRAPHIC

Contact:

Robert Jaffe

 

 

Robert Jaffe Co., LLC

 

 

(424) 288-4098

 

LANNETT REPORTS FISCAL 2017 FIRST-QUARTER FINANCIAL RESULTS

 

—Net Sales Increased 52% to Approximately $162 Million;

Company Revises Guidance for Fiscal 2017—

 

Philadelphia, PA November 3, 2016 — Lannett Company, Inc. (NYSE: LCI) today reported financial results for its fiscal 2017 first quarter ended September 30, 2016.  The company completed the acquisition of Kremers Urban Pharmaceuticals Inc. (KU) on November 25, 2015; accordingly, fiscal 2017 first-quarter financial results include the operations of KU.

 

“We are pleased to report in our fiscal 2017 first quarter a topline increase of 52 percent, which was largely due to the addition of KU’s operations,” said Arthur Bedrosian, chief executive officer of Lannett.  “Net sales were approximately $162 million compared with $106 million in the same period last year.  Our first quarter performance includes strong sales on certain products, offset by the effect of competitive pressure on a number of our other products.  In addition, contract manufacturing revenues were lower than anticipated due to timing of product shipments.

 

“Looking ahead, we recently announced positive results of a Phase III clinical trial of our proprietary product, as well as successful FDA inspections of three of our facilities and FDA approval of our Buprenorphine and Naloxone sublingual tablets product.  These milestones, in conjunction with our ongoing progress to reduce costs and integrate KU, are important steps toward achieving our near-term goals and executing our long-term strategy.”

 

Commenting on the company’s revised guidance for fiscal 2017, Bedrosian added, “We have a deep product pipeline, including a significant number of ANDAs currently pending at the FDA, which has the potential to add considerable upside to our updated forecasts.  We expect the remaining quarters of the current fiscal year to be stronger than our first quarter performance, and our adjusted full-year profitability to be higher than last year.”

 

For the fiscal 2017 first quarter, net sales increased 52% to $161.6 million from $106.4 million for the first quarter of fiscal 2016.  Gross profit was $81.9 million compared with $77.4 million.  Gross profit as a percentage of net sales was 51% compared with 73% in last year’s first quarter, primarily due to the inclusion of KU’s lower-margin business, as well as amortization of acquired intangible assets and other purchase accounting related expenses.  Research and development (R&D) expenses increased to $12.4 million from $6.5 million for the fiscal 2016 first quarter.  Selling, general and administrative (SG&A) expenses were $21.3 million compared with $15.5 million.  Acquisition and integration-related expenses were $1.4 million compared with $3.9 million in the prior-year first quarter.  In the first quarter of fiscal 2017, the company recorded restructuring expenses of $2.1 million related to a cost reduction plan implemented in February 2016.  Also in the first quarter of fiscal 2017, the company recorded an

 



 

impairment charge of $65.1 million related to the intangible asset value attributable to Methylphenidate Hydrochloride Extended-Release tablets.  Operating loss was $20.3 million versus operating income of $51.4 million.  Income tax benefit was $12.9 million compared to income tax expense of $17.1 million in the prior-year first quarter.  Interest expense was $23.0 million compared with $60 thousand for the first quarter of fiscal 2016.  Net loss attributable to Lannett was $29.4 million, or $0.80 per share, compared to net income attributable to Lannett of $33.2 million, or $0.89 per diluted share, for the fiscal 2016 first quarter.

 

For the fiscal 2017 first quarter reported on a Non-GAAP basis, adjusted net sales increased to $161.6 million from $106.4 million for the first quarter of fiscal 2016.  Adjusted gross profit was $94.0 million, or 58% of adjusted net sales, compared with $77.8 million, or 73% of adjusted net sales, for the fiscal 2016 first quarter.  Adjusted R&D expenses increased to $12.4 million from $6.5 million.  Adjusted SG&A expenses were $20.9 million compared with $13.9 million.  Adjusted operating income increased to $60.7 million from $57.3 million for the prior-year first quarter.  Adjusted net income attributable to Lannett was $29.0 million, or $0.77 per diluted share, compared with $37.1 million, or $0.99 per diluted share, for the fiscal 2016 first quarter.

 

Guidance for Fiscal 2017

 

The company has revised its GAAP guidance to reflect, among other things, the non-cash impairment charge of approximately $65 million.  On an adjusted basis, the company expects profitability to modestly improve.  Based on its current outlook, the company revised financial guidance for the 2017 fiscal year as follows:

 

 

 

GAAP

 

Adjusted

Net sales

 

$675 million to $685 million; down from $690 million to $700 million

 

$675 million to $685 million; down from $690 million to $700 million

Gross margin %

 

51.5% to 52.5%, up from 50% to 51%

 

57.5% to 58.5%; up from 55% to 56%

R&D expense

 

$49 million to $51 million; unchanged

 

$49 million to $51 million; unchanged

SG&A expense

 

$72 million to $74 million, up from $68 million to $70 million;

 

$70 million to $72 million; up from $67 million to $69 million

Acquisition related, integration and restructuring expense

 

$10 million to $11 million; unchanged

 

$0; unchanged

Impairment charge

 

$65 million

 

$0

Interest expense

 

$90 million to $91 million; down from $93 million to $94 million

 

$71 million to $72 million; unchanged

Effective tax rate

 

Approximately 34%; unchanged

 

Approximately 34%, unchanged

Capital expenditures

 

$55 million to $65 million; unchanged

 

$55 million to $65 million; unchanged

 

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 2017 first quarter ended September 30, 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 43660920.  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).  Management uses these measures internally for evaluating its operating performance.  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.  Detailed reconciliations of non-GAAP financial measures to the most directly comparable GAAP financial measures are included with this release.

 

Adjusted net income and Adjusted earnings per diluted share exclude, among others, the effects of (1) amortization of purchased intangibles and other purchase accounting entries, (2) acquisition and integration-related expenses, (3) impairment charge, (4) non-cash interest expense, as well as (5) certain other items considered unusual or non-recurring in nature.

 

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 — see financial schedule below for net sales by medical indication.  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, significantly reducing costs, expanding the pipeline, receiving approval and successfully commercializing the company’s proprietary product, commercializing product approvals including Buprenorphine and Naloxone sublingual tablets, and achieving the financial metrics stated in the company’s guidance for fiscal 2017, 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)

 

 

 

 

 

September 30, 2016

 

June 30, 2016

 

 

 

 

 

 

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

241,680

 

$

224,769

 

Investment securities

 

11,381

 

14,094

 

Accounts receivable, net

 

190,526

 

211,722

 

Inventories

 

127,751

 

114,904

 

Prepaid income taxes

 

22,933

 

 

Deferred tax assets

 

44,001

 

40,892

 

Other current assets

 

7,681

 

6,434

 

Total current assets

 

645,953

 

612,815

 

Property, plant and equipment, net

 

221,343

 

216,638

 

Intangible assets, net

 

501,167

 

575,503

 

Goodwill

 

339,566

 

333,611

 

Deferred tax assets

 

11,879

 

11,556

 

Other assets

 

14,148

 

13,895

 

TOTAL ASSETS

 

$

1,734,056

 

$

1,764,018

 

 

 

 

 

 

 

LIABILITIES

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

43,987

 

$

34,720

 

Accrued expenses

 

8,289

 

9,247

 

Accrued payroll and payroll-related expenses

 

8,947

 

10,572

 

Rebates payable

 

20,103

 

21,894

 

Royalties payable

 

4,158

 

5,127

 

Restructuring liability

 

4,767

 

4,130

 

Settlement liability

 

9,000

 

7,000

 

Income taxes payable

 

 

743

 

Acquisition-related contingent consideration

 

35,000

 

35,000

 

Short-term borrowings and current portion of long-term debt

 

178,238

 

178,236

 

Total current liabilities

 

312,489

 

306,669

 

Long-term debt, net

 

875,450

 

883,612

 

Settlement liability

 

10,860

 

12,526

 

Other liabilities

 

7,534

 

6,754

 

TOTAL LIABILITIES

 

1,206,333

 

1,209,561

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY

 

 

 

 

 

Common stock ($0.001 par value, 100,000,000 shares authorized; 37,406,625 and 37,150,165 shares issued; 36,801,759 and 36,604,202 shares outstanding at September 30, 2016 and June 30, 2016, respectively)

 

37

 

37

 

Additional paid-in capital

 

287,756

 

283,301

 

Retained earnings

 

248,947

 

278,355

 

Accumulated other comprehensive loss

 

(298

)

(295

)

Treasury stock (604,866 and 545,963 shares at September 30, 2016 and June 30, 2016, respectively)

 

(9,147

)

(7,349

)

Total Lannett Company, Inc. stockholders’ equity

 

527,295

 

554,049

 

Noncontrolling interest

 

428

 

408

 

Total stockholders’ equity

 

527,723

 

554,457

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

1,734,056

 

$

1,764,018

 

 



 

LANNETT COMPANY, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)

(In thousands, except share and per share data)

 

 

 

Three months ended

 

 

 

September 30,

 

 

 

2016

 

2015

 

 

 

 

 

 

 

Net sales

 

$

161,559

 

$

106,433

 

Cost of sales

 

70,820

 

28,819

 

Amortization of intangibles

 

8,887

 

187

 

Gross profit

 

81,852

 

77,427

 

Operating expenses:

 

 

 

 

 

Research and development expenses

 

12,371

 

6,528

 

Selling, general and administrative expenses

 

21,260

 

15,536

 

Acquisition and integration-related expenses

 

1,391

 

3,942

 

Restructuring expenses

 

2,052

 

 

Intangible asset impairment charge

 

65,084

 

 

Total operating expenses

 

102,158

 

26,006

 

Operating income (loss)

 

(20,306

)

51,421

 

Other income (loss):

 

 

 

 

 

Investment income (loss)

 

1,027

 

(1,110

)

Interest expense

 

(22,994

)

(60

)

Other

 

3

 

 

Total other income (loss)

 

(21,964

)

(1,170

)

Income (loss) before income tax

 

(42,270

)

50,251

 

Income tax expense (benefit)

 

(12,882

)

17,055

 

Net income (loss)

 

(29,388

)

33,196

 

Less: Net income attributable to noncontrolling interest

 

20

 

15

 

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

 

$

(29,408

)

$

33,181

 

 

 

 

 

 

 

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

 

 

 

 

 

Basic

 

$

(0.80

)

$

0.91

 

Diluted

 

$

(0.80

)

$

0.89

 

 

 

 

 

 

 

Weighted average common shares outstanding:

 

 

 

 

 

Basic

 

36,699,267

 

36,310,653

 

Diluted

 

36,699,267

 

37,414,724

 

 



 

LANNETT COMPANY, INC.

RECONCILIATION OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION

(In thousands, except share and per share data)

 

 

 

Three months ended

 

Three months ended

 

 

 

September 30,

 

September 30,

 

 

 

GAAP

 

 

 

Non-GAAP

 

GAAP

 

 

 

Non-GAAP

 

 

 

Reported

 

Adjustments

 

Adjusted

 

Reported

 

Adjustments

 

Adjusted

 

 

 

2016

 

2016

 

2016

 

2015

 

2015

 

2015

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net sales

 

$

161,559

 

$

 

$

161,559

 

$

106,433

 

$

 

$

106,433

 

Cost of sales

 

70,820

 

(3,274

)(a)

67,546

 

28,819

 

(140

)(a)

28,679

 

Amortization of intangibles

 

8,887

 

(8,887

)(b)

 

187

 

(187

)(b)

 

Gross profit

 

81,852

 

12,161

 

94,013

 

77,427

 

327

 

77,754

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

12,371

 

 

12,371

 

6,528

 

 

6,528

 

Selling, general, and administrative expenses

 

21,260

 

(365

)(c)

20,895

 

15,536

 

(1,652

)(d)

13,884

 

Acquisition and integration-related expenses

 

1,391

 

(1,391

)(e)

 

3,942

 

(3,942

)(e)

 

Restructuring expenses

 

2,052

 

(2,052

)(f)

 

 

 

 

Intangible asset impairment charge

 

65,084

 

(65,084

)(g)

 

 

 

 

Total operating expenses

 

102,158

 

(68,892

)

33,266

 

26,006

 

(5,594

)

20,412

 

Operating income (loss)

 

(20,306

)

81,053

 

60,747

 

51,421

 

5,921

 

57,342

 

Other income (loss)

 

(21,964

)

4,870

(h)

(17,094

)

(1,170

)

 

(1,170

)

Income (loss) before income tax

 

(42,270

)

85,923

 

43,653

 

50,251

 

5,921

 

56,172

 

Income tax expense (benefit)

 

(12,882

)

27,524

(i)

14,642

 

17,055

 

2,034

(i)

19,089

 

Net income (loss)

 

(29,388

)

58,399

 

29,011

 

33,196

 

3,887

 

37,083

 

Less: Net income attributable to noncontrolling interest

 

20

 

 

20

 

15

 

 

15

 

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

 

$

(29,408

)

$

58,399

 

$

28,991

 

$

33,181

 

$

3,887

 

$

37,068

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.80

)

 

 

$

0.79

 

$

0.91

 

 

 

$

1.02

 

Diluted

 

$

(0.80

)

 

 

$

0.77

 

$

0.89

 

 

 

$

0.99

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

36,699,267

 

 

 

36,699,267

 

36,310,653

 

 

 

36,310,653

 

Diluted

 

36,699,267

 

 

 

37,585,994

 

37,414,724

 

 

 

37,414,724

 

 


(a) 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 acquisitions of Kremers Urban Pharmaceuticals, Inc. and Silarx Pharmaceuticals, Inc.

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

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

(d) To exclude separation payments associated with the retirement of an executive officer

(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 an impairment charge related to a certain intangible asset acquired as part of the Kremers Urban Pharmaceuticals Inc. acquisition

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

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

 



 

LANNETT COMPANY, INC.

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

($ in millions)

 

 

 

Fiscal Year 2017 Guidance

 

 

 

 

 

 

 

Non-GAAP

 

 

 

GAAP

 

Adjustments

 

Adjusted

 

 

 

 

 

 

 

 

 

Net sales

 

$675 - $685

 

 

$675 - $685

 

Gross margin percentage

 

51.5% - 52.5%

 

6%

(a)

57.5% to 58.5%

 

R&D expense

 

$49 - $51

 

 

$49 - $51

 

SG&A expense

 

$72 - $74

 

($2)

(b)

$70 - $72

 

Integration and Restructuring expense

 

$10 - $11

 

($10 - $11)

(c)

 

Impairment charge

 

$65

 

($65)

(d)

 

Interest expense

 

$90 - $91

 

($19)

(e)

$71 - $72

 

Effective tax rate

 

approx. 34%

 

 

approx. 34%

 

Capital expenditures

 

$55 - $65

 

 

 

$55 - $65

 

 


(a) The adjustment primarily reflects amortization of purchased intangible assets and depreciation of a fair value step-up in property, plant and equipment related to the acquisition of Kremers Urban Pharmaceuticals, Inc.

(b) The adjustment reflects amortization of purchased intangible assets related to the acquisition of Kremers Urban Pharmaceuticals, Inc.

(c) The adjustment reflects expenses related to the 2016 Restructuring Plan as well as integration-related expenses associated with the acquisition of Kremers Urban Pharmaceuticals, Inc.

(d) The adjustment reflects an impairment charge related to an intangible asset acquired as part of the Kremers Urban Pharmaceuticals Inc. acquisition

(e) The adjustment primarily reflects non-cash interest expense associated with debt issuance costs

 



 

LANNETT COMPANY, INC.

SALES BY MEDICAL INDICATION

 

 

 

Three months ended

 

(in thousands)

 

September 30,

 

Medical Indication

 

2016

 

2015

 

Antibiotic

 

$

3,780

 

$

2,727

 

Anti Psychosis

 

17,320

 

2,742

 

Cardiovascular

 

12,694

 

8,303

 

Central Nervous System

 

10,350

 

 

Gallstone

 

12,883

 

19,972

 

Gastrointestinal

 

18,052

 

76

 

Glaucoma

 

5,783

 

6,822

 

Migraine

 

7,160

 

5,542

 

Muscle Relaxant

 

3,532

 

1,661

 

Obesity

 

835

 

979

 

Pain Management

 

6,608

 

8,133

 

Respiratory

 

2,213

 

 

Thyroid Deficiency

 

39,838

 

41,102

 

Urinary

 

5,101

 

215

 

Other

 

10,347

 

8,159

 

Contract Manufacturing

 

5,063

 

 

Net Sales

 

$

161,559

 

$

106,433