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EX-99.2 - EX-99.2 - LANNETT CO INCa18-39808_1ex99d2.htm
8-K - 8-K - LANNETT CO INCa18-39808_18k.htm

Exhibit 99.1

 

 

 

Contact:

Robert Jaffe

 

 

Robert Jaffe Co., LLC

 

 

(424) 288-4098

 

LANNETT ANNOUNCES FISCAL 2019 FIRST-QUARTER FINANCIAL RESULTS;

RE-AFFIRMS ADJUSTED GUIDANCE FOR FISCAL 2019

 

·                  Fiscal 2019 First Quarter Net Sales and Adjusted Net Income Ahead of Expectations

·                  16 Products Launched January to November 2018 that are Forecasted to Contribute Approximately $75 Million of Revenues in Fiscal 2019

·                  Finalized Plan to Achieve $66 Million Annualized Cost Savings by Fiscal 2020; $33 Million of Savings to be Re-invested in Growth Opportunities

 

Philadelphia, PA November 7, 2018 — Lannett Company, Inc. (NYSE: LCI) today reported financial results for its fiscal 2019 first quarter ended September 30, 2018.

 

“For the fiscal 2019 first quarter, net sales and adjusted net income exceeded our expectations,” said Tim Crew, chief executive officer of Lannett.  “A key driver to our performance was the combined contribution of new products launched since January 1st of this year.  Our plans for the balance of fiscal 2019 include additional product launches of both recently acquired and internally developed products.

 

“We made solid progress on other fronts to position the company for continued improvement.  During the first quarter and into the current period, we completed several transactions that added a number of attractive market ready products to our portfolio.  In addition, we significantly increased our cash position and finalized a cost reduction plan that we expect when fully implemented will generate annualized cost savings of approximately $66 million comparing fiscal 2020 to fiscal 2018 expenses.  We plan to re-invest or redeploy approximately $33 million of the cost savings back into our business.  The plan includes decreased spending throughout the organization and workforce reductions.  As part of the plan, we also intend to sell our Cody Laboratories active pharmaceutical ingredients business, a move that will provide immediate and substantial expense reductions and allow us to better focus on nearer and medium term growth opportunities.

 

“Given the above, we are excited about our future and accordingly, we have re-affirmed the company’s fiscal 2019 adjusted financial guidance.”

 

For the fiscal 2019 first quarter, on a GAAP basis, net sales were $155.1 million compared with $155.0 million for the first quarter of fiscal 2018.  Gross profit was $59.1 million, or 38% of total net sales, compared with $67.7 million, or 44% of total net sales.  Research and development (R&D) expenses were $9.8 million compared with $7.4 million for the fiscal 2018 first quarter.  Selling, general and administrative (SG&A) expenses increased to $20.6 million from $19.0 million.  Restructuring expenses were $1.0 million compared with $0.5 million.  As previously disclosed, the company recorded in its fiscal 2019 first quarter non-cash charges totaling $369.5 million related to the full impairment of goodwill, resulting from the non-renewal of the distribution agreement with Jerome Stevens Pharmaceuticals when the contract expires in March 2019, and the impairment of certain long-lived assets as a result of the plan to sell its Cody Laboratories API business.  Operating loss was $341.8 million compared to operating income of $40.7 million.  Interest expense was $21.4 million compared with $20.9 million for the first quarter of fiscal 2018.  The company recorded an income tax benefit of $75.6 million versus income tax expense of $7.4 million in the prior-year period.  Net loss was $287.5 million, or $7.65 per share, versus net income of $13.3 million, or $0.35 per diluted share, for the fiscal 2018 first quarter.

 


 

For the fiscal 2019 first quarter reported on a Non-GAAP basis, adjusted net sales were $155.1 million compared with $155.0 million for the first quarter of fiscal 2018.  Adjusted gross profit was $68.7 million, or 44% of adjusted net sales, compared with $76.7 million, or 50% of adjusted net sales, for the prior-year first quarter.  Adjusted R&D expenses were $9.8 million compared with $7.4 million.  Adjusted SG&A expenses were $19.2 million compared with $18.7 million.  Adjusted operating income was $39.6 million compared with $50.7 million for the prior-year first quarter.  Adjusted interest expense was $16.9 million compared with $16.4 million for the first quarter of fiscal 2018.  Adjusted income tax expense was $5.9 million compared with $12.5 million in the prior-year period.  Adjusted net income was $16.9 million, or $0.44 per diluted share, compared with $22.7 million, or $0.60 per diluted share, for the fiscal 2018 first quarter.

 

Guidance for Fiscal 2019

 

Based on its current outlook, the company has revised its GAAP estimates to, among other things, include asset impairment charges of $369 million and re-affirmed adjusted financial guidance for the 2019 fiscal year (minor increases to estimates of Net sales and R&D expense), as follows:

 

 

 

GAAP

 

Adjusted

Net sales

 

$585 million to $615 million

 

$585 million to $615 million

Gross margin %

 

38% to 39%

 

44% to 45%

R&D expense

 

$32 million to $36 million

 

$30 million to $34 million

SG&A expense

 

$75 million to $78 million

 

$63 million to $66 million

Restructuring expense

 

$3 million to $4 million

 

$—

Asset impairment charges

 

$369 million

 

$—

Interest expense

 

$81 million to $83 million

 

$63 million to $65 million

Effective tax rate

 

22% to 23%

 

22% to 23%

Capital expenditures

 

$30 million to $35 million

 

$30 million to $35 million

 

The financial guidance table above includes “Asset impairment charges.”  This item was not included in the guidance provided on August 28, 2018, because, at that time, the company could not estimate the amount or a reasonable range of amounts of such impairment.

 


 

Product Launches / Cost Savings

 

The company has posted additional information related to new product launches and cost savings on its website.  If interested, please visit http://lannett.investorroom.com/news-releases.

 

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 its fiscal 2019 first quarter ended September 30, 2018.  The conference call will be available to interested parties by dialing 866-436-9172 from the U.S. or Canada, or 630-691-2760 from international locations, passcode 47800134.  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, 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.

 

Non-GAAP financial measures exclude, among others, the effects of (1) amortization of purchased intangibles and other purchase accounting entries, (2) acquisition and integration-related expenses, (3) non-cash interest expense, as well as (4) 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, the impact of the non-renewal of the distribution agreement with Jerome Stevens Pharmaceuticals, successfully launching and commercializing recently acquired and previously approved products, realizing enhanced efficiencies, successfully consummating transactions with new and existing alliance partners and successfully launching and commercializing products included therein, and achieving the financial metrics stated in the company’s guidance for fiscal 2019, 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)

 

 

 

September 30, 2018

 

June 30, 2018

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

150,327

 

$

98,586

 

Accounts receivable, net

 

205,350

 

252,651

 

Inventories

 

145,915

 

141,635

 

Prepaid income taxes

 

1,690

 

15,159

 

Assets held for sale

 

13,245

 

13,976

 

Other current assets

 

7,859

 

4,863

 

Total current assets

 

524,386

 

526,870

 

Property, plant and equipment, net

 

195,880

 

233,247

 

Intangible assets, net

 

416,016

 

424,425

 

Goodwill

 

 

339,566

 

Deferred tax assets

 

99,761

 

22,063

 

Other assets

 

21,612

 

29,133

 

TOTAL ASSETS

 

$

1,257,655

 

$

1,575,304

 

 

 

 

 

 

 

LIABILITIES

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

48,558

 

$

56,767

 

Accrued expenses

 

5,732

 

7,425

 

Accrued payroll and payroll-related expenses

 

10,009

 

7,819

 

Rebates payable

 

36,489

 

49,400

 

Royalties payable

 

5,878

 

5,955

 

Restructuring liability

 

6,911

 

6,706

 

Liabilities held for sale

 

2,010

 

 

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

 

66,845

 

66,845

 

Total current liabilities

 

182,432

 

200,917

 

Long-term debt, net

 

760,127

 

772,425

 

Other liabilities

 

3,073

 

3,047

 

TOTAL LIABILITIES

 

945,632

 

976,389

 

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY

 

 

 

 

 

Common stock ($0.001 par value, 100,000,000 shares authorized; 38,665,268 and 38,256,839 shares issued; 37,734,758 and 37,380,517 shares outstanding at September 30, 2018 and June 30, 2018, respectively)

 

39

 

38

 

Additional paid-in capital

 

310,135

 

306,817

 

Retained earnings

 

16,653

 

306,464

 

Accumulated other comprehensive loss

 

(509

)

(515

)

Treasury stock (930,510 and 876,322 shares at September 30, 2018 and June 30, 2018, respectively)

 

(14,295

)

(13,889

)

Total stockholders’ equity

 

312,023

 

598,915

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

1,257,655

 

$

1,575,304

 

 


 

LANNETT COMPANY, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except share and per share data)

 

 

 

(UNAUDITED)

 

 

 

Three months ended

 

 

 

September 30,

 

 

 

2018

 

2017

 

 

 

 

 

 

 

Net sales

 

$

155,054

 

$

154,961

 

Cost of sales

 

87,690

 

79,553

 

Amortization of intangibles

 

8,223

 

7,737

 

Gross profit

 

59,141

 

67,671

 

Operating expenses:

 

 

 

 

 

Research and development expenses

 

9,810

 

7,409

 

Selling, general, and administrative expenses

 

20,588

 

19,038

 

Acquisition and integration-related expenses

 

 

18

 

Restructuring expenses

 

1,022

 

527

 

Asset impairment charges

 

369,499

 

 

Total operating expenses

 

400,919

 

26,992

 

Operating income (loss)

 

(341,778

)

40,679

 

Other income (loss):

 

 

 

 

 

Investment income

 

379

 

1,164

 

Interest expense

 

(21,433

)

(20,912

)

Other

 

(296

)

(251

)

Total other loss

 

(21,350

)

(19,999

)

Income (loss) before income tax

 

(363,128

)

20,680

 

Income tax expense (benefit)

 

(75,600

)

7,423

 

Net income (loss)

 

$

(287,528

)

$

13,257

 

 

 

 

 

 

 

Earnings (loss) per common share:

 

 

 

 

 

Basic

 

$

(7.65

)

$

0.36

 

Diluted

 

$

(7.65

)

$

0.35

 

 

 

 

 

 

 

Weighted average common shares outstanding:

 

 

 

 

 

Basic

 

37,586,327

 

36,992,064

 

Diluted

 

37,586,327

 

37,730,656

 

 


 

LANNETT COMPANY, INC.

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

(In thousands, except percentages, share and per share data)

 

 

 

Three months ended September 30, 2018

 

 

 

Net sales

 

Cost of
sales

 

Amortization
of intangibles

 

Gross
Profit

 

Gross
Margin %

 

R&D
expense

 

SG&A
expense

 

Restructuring
expenses

 

Asset impairment
charges

 

Operating
income (loss)

 

Other
income
(loss)

 

Income (loss)
before income
tax

 

Income tax
expense
(benefit)

 

Net income
(loss)

 

Diluted
earnings
(loss) per
share (h)

 

GAAP Reported

 

$

155,054

 

$

87,690

 

$

8,223

 

$

59,141

 

38

%

$

9,810

 

$

20,588

 

$

1,022

 

$

369,499

 

$

(341,778

)

$

(21,350

)

$

(363,128

)

$

(75,600

)

$

(287,528

)

$

(7.65

)

Adjustments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Depreciation of Fixed Assets step-up (a)

 

 

(1,335

)

 

1,335

 

 

 

 

 

 

 

1,335

 

 

1,335

 

 

1,335

 

 

 

Amortization of intangibles (b)

 

 

 

(8,223

)

8,223

 

 

 

 

 

 

 

8,223

 

 

8,223

 

 

8,223

 

 

 

Restructuring expenses (c)

 

 

 

 

 

 

 

 

 

(1,022

)

 

1,022

 

 

1,022

 

 

1,022

 

 

 

Asset impairment charges (d)

 

 

 

 

 

 

 

 

 

 

(369,499

)

369,499

 

 

369,499

 

 

369,499

 

 

 

Non-cash interest (e)

 

 

 

 

 

 

 

 

 

 

 

 

4,538

 

4,538

 

 

4,538

 

 

 

Other (f)

 

 

 

 

 

 

 

 

(1,340

)

 

 

1,340

 

 

1,340

 

 

1,340

 

 

 

Tax adjustments (g)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

81,504

 

(81,504

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP Adjusted

 

$

155,054

 

$

86,355

 

$

 

$

68,699

 

44

%

$

9,810

 

$

19,248

 

$

 

$

 

$

39,641

 

$

(16,812

)

$

22,829

 

$

5,904

 

$

16,925

 

$

0.44

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


(a)

 

Relates to depreciation of a fair value step-up in property, plant and equipment related to the acquisition of Kremers Urban Pharmaceuticals, Inc. (“KUPI”)

(b)

 

Relates to amortization of purchased intangible assets primarily related to the acquisitions of KUPI and Silarx Pharmaceuticals, Inc.

(c)

 

To exclude expenses associated with the 2016 Restructuring Plan and, to a lesser extent, the Cody Restructuring Plan

(d)

 

To exclude asset impairment charges related to goodwill and other long-lived assets

(e)

 

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

(f)

 

To primarily exclude depreciation on previously capitalized software integration costs associated with the KUPI acquisition

(g)

 

The tax effect of the pre-tax adjustments included at applicable tax rates

(h)

 

The weighted average share number for the three months ended September 30, 2018 is 37,586,327 for GAAP and 38,752,010 for the non-GAAP earnings (loss) per share calculations

 


 

LANNETT COMPANY, INC.

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

(In thousands, except percentages, share and per share data)

 

 

 

Three months ended September 30, 2017

 

 

 

Net sales

 

Cost of
sales

 

Amortization
of intangibles

 

Gross
Profit

 

Gross
Margin %

 

R&D
expense

 

SG&A
expense

 

Acquisition and
integration-
related
expenses

 

Restructuring
expenses

 

Operating
income

 

Other
income
(loss)

 

Income
before
income tax

 

Income tax
expense

 

Net income

 

Diluted
earnings
per share
(g)

 

GAAP Reported

 

$

154,961

 

$

79,553

 

$

7,737

 

$

67,671

 

44

%

$

7,409

 

$

19,038

 

$

18

 

$

527

 

$

40,679

 

$

(19,999

)

$

20,680

 

$

7,423

 

$

13,257

 

$

0.35

 

Adjustments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Depreciation of Fixed Assets step-up (a)

 

 

(1,335

)

 

1,335

 

 

 

 

 

 

 

1,335

 

 

1,335

 

 

1,335

 

 

 

Amortization of intangibles (b)

 

 

 

(7,737

)

7,737

 

 

 

 

(365

)

 

 

8,102

 

 

8,102

 

 

8,102

 

 

 

Acquisition and integration-related expenses (c)

 

 

 

 

 

 

 

 

 

(18

)

 

18

 

 

18

 

 

18

 

 

 

Restructuring expenses (d)

 

 

 

 

 

 

 

 

 

 

(527

)

527

 

 

527

 

 

527

 

 

 

Non-cash interest (e)

 

 

 

 

 

 

 

 

 

 

 

 

4,560

 

4,560

 

 

4,560

 

 

 

Tax adjustments (f)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5,123

 

(5,123

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP Adjusted

 

$

154,961

 

$

78,218

 

$

 

$

76,743

 

50

%

$

7,409

 

$

18,673

 

$

 

$

 

$

50,661

 

$

(15,439

)

$

35,222

 

$

12,546

 

$

22,676

 

$

0.60

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


(a)

 

Relates to depreciation of a fair value step-up in property, plant and equipment related to the acquisition of Kremers Urban Pharmaceuticals, Inc. (“KUPI”)

(b)

 

Relates to amortization of purchased intangible assets primarily related to the acquisitions of KUPI and Silarx Pharmaceuticals, Inc.

(c)

 

Relates to acquisition and integration-related expenses primarily related to the acquisition of KUPI

(d)

 

To exclude expenses associated with the 2016 Restructuring Plan

(e)

 

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

(f)

 

The tax effect of the pre-tax adjustments included at applicable tax rates

(g)

 

The weighted average share number for the three months ended September 30, 2017 is 37,730,656 for both the GAAP and the non-GAAP earnings per share calculations

 


 

LANNETT COMPANY, INC.

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

($ in millions)

 

 

 

Fiscal Year 2019 Guidance

 

 

 

 

 

 

 

Non-GAAP

 

 

 

GAAP

 

Adjustments

 

Adjusted

 

 

 

 

 

 

 

 

 

Net sales

 

$585 - $615

 

 

$585 - $615

 

Gross margin percentage

 

38.0% - 39.0%

 

6%

(a)

44.0% to 45.0%

 

R&D expense

 

$32 - $36

 

($2)

(b)

$30 - $34

 

SG&A expense

 

$75 - $78

 

($12)

(c)

$63 - $66

 

Restructuring expense

 

$3 - $4

 

($3 - $4)

(d)

 

Asset impairment charges

 

$369

 

($369)

(e)

 

Interest expense

 

$81 - $83

 

($18)

(f)

$63 - $65

 

Effective tax rate

 

22% to 23%

 

 

22% to 23%

 

Capital expenditures

 

$30 - $35

 

 

$30 - $35

 

 


(a) The adjustment primarily reflects amortization of purchased intangible assets related to the acquisition of Kremers Urban Pharmaceuticals, Inc. (“KUPI”) and, to a lesser extent, the cost of sales associated with the Cody API business which is classified as Held For Sale as of September 30, 2018

(b) To exclude R&D expense associated with the Cody API business which is classified as Held For Sale as of September 30, 2018

(c) To exclude various expenses associated with the Company’s overall cost savings initiatives, which includes the operating costs of the Cody API business subsequent to September 30, 2018, the date it was classified as Held For Sale; legal and financial advisory costs; as well as nonrecurring compensation related expenses.  In addition, it also excludes depreciation on previously capitalized software integration costs associated with the KUPI acquisition

(d) To exclude expenses associated with the 2016 Restructuring Plan and Cody Restructuring Plan

(e) To exclude asset impairment charges related to goodwill and other long-lived assets

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

 


 

LANNETT COMPANY, INC.

NET SALES BY MEDICAL INDICATION

 

 

 

Three months ended

 

(in thousands)

 

September 30,

 

Medical Indication

 

2018

 

2017

 

Antibiotic

 

$

4,089

 

$

3,349

 

Anti-Psychosis

 

10,889

 

14,991

 

Cardiovascular

 

21,770

 

11,306

 

Central Nervous System

 

7,197

 

8,818

 

Gallstone

 

2,214

 

6,564

 

Gastrointestinal

 

15,040

 

14,553

 

Glaucoma

 

548

 

2,668

 

Migraine

 

9,737

 

15,015

 

Muscle Relaxant

 

3,179

 

3,791

 

Pain Management

 

4,947

 

5,761

 

Respiratory

 

1,015

 

1,647

 

Thyroid Deficiency

 

53,878

 

47,214

 

Urinary

 

1,552

 

2,997

 

Other

 

14,338

 

12,696

 

Contract manufacturing revenue

 

4,661

 

3,591

 

Net Sales

 

$

155,054

 

$

154,961