Paladin Labs Reports Second Quarter 2013 Results

Achieves Record EBITDA(1)

MONTREAL, CANADA--(Marketwired - Aug. 14, 2013) - Paladin Labs Inc. (PLB.TO), a leading specialty pharmaceutical company, today reported its financial results for the quarter ended June 30, 2013.

2013 Second Quarter Highlights

Financial

  • Adjusted(2) revenues reached $52.3 million, an increase of 41% over the same period last year

  • Adjusted(2) EBITDA(1) reached $22.7 million, an increase of 32% over the same period last year

Product Developments

  • Acquired Binotal® from Bayer Pharma AG ("Bayer") for Latin America including Mexico, Brazil, Columbia, Ecuador and select countries in Central America

  • Launched Silenor® (doxepin hydrochloride) for the treatment and symptomatic relief of insomnia

  • Launched Amniosense™, Canada's first OTC amniotic fluid leak detection test

  • Submitted a new drug application ("NDA") to the U.S. Food and Drug Administration (FDA) for Impavido® (miltefosine) and received priority review status

Corporate Developments

  • Completed a strategic collaboration to refinance and increase Bioniche's debt for up to US $30 million, to provide new equity of up to $0.5 million, and to enter into a licensing agreement for Bioniche's Phase III bladder cancer product - Urocidin™ for Canada, South Africa and Mexico.

  • Amended a secured loan agreement with Nuvo Research Inc. ("Nuvo") to issue a second tranche of $4 million, add a potential third $4 million loan tranche and issue up to 100,000 warrants to acquire Nuvo common shares

  • Issued a combined balance of $4.2 million secured loans to two additional undisclosed pharmaceutical companies

  • Entered into license agreement with Altus Formulation Inc. ("Altus") for certain Labopharm Inc technology in exchange for a 35% equity ownership interest

Subsequent to the quarter

  • Closed the agreements related to Bioniche and Nuvo

  • Acquired Allon Therapeutics Inc. ("Allon")

"In the second quarter, Paladin posted record EBITDA(1) while continuing to invest in its product portfolio and pipeline. Paladin further expanded its Latin American footprint with the acquisition of Binotal for Latin America and select Central American countries. In addition, we expanded our product portfolio and pipeline with the launch of Silenor and Amniosense and the in-licensing of Phase III product Urocidin. Furthermore, we deployed nearly $40 million through secured strategic loans to four pharmaceutical companies" said Mark Beaudet, interim President and CEO of Paladin Labs.

Financial Results

Adjusted(2) revenues increased $15.2 million or 41% to $52.3 million for the second quarter of 2013 from $37.1 million for the same period in 2012. The increase is mostly attributable to the proportionate consolidation of Litha's revenues of $11.9 million for the quarter ended June 30, 2013. Paladin's promoted products, including Tridural®, Trelstar®, Testim®, Abstral®, Digifab®, Glucagen®, Oralair® and Pollinex®-R combined increased by 30% for the quarter compared to the same period last year.

Consolidated revenues for the quarter ended June 30, 2013 were $67.2 million, an increase of 81% over the same period last year. The increase is mostly attributable to the consolidation of Litha's revenues of $26.8 million for the quarter.

Second quarter 2013 adjusted(2) EBITDA(1) increased 32% to $22.7 million, compared to adjusted(2) EBITDA(1) of $17.2 million in the second quarter of 2012. This increase is primarily due to the strong sales performance of Paladin's promoted products, partially offset by increased costs associated with the launch of new products. Litha contributed $1.8 million to adjusted(2) EBITDA(1) which includes impact of higher gross income margins as a result of the mix of products sold in the quarter offset by the impact of the continued decline in the South African Rand.

Consolidated EBITDA(1) reached a record $24.9 million, an increase of 44% over the consolidated EBITDA(1) for the quarter ended June 30, 2012. This increase is primarily due to the consolidation of Litha, which contributed $4.0 million in consolidated EBITDA(1) for the quarter.

Net income attributable to shareholders for the quarter was $13.6 million or $0.64 per fully diluted share, compared to net income attributable to shareholders of $10.9 million or $0.52 per fully diluted share the same quarter a year ago.

As at June 30 2013, Paladin's cash, cash equivalents and investments in marketable securities net of bank overdraft totaled $247.7 million. From this strong cash position, Paladin continues to pursue business and corporate development opportunities.

Product Developments

During the second quarter of 2013, Paladin advanced its product portfolio and pipeline.

Paladin grew its international business with the acquisition of Binotal from Bayer for Latin America and select countries in Central America. Binotal is used for the systemic treatment of a wide range of bacterial infections. Binotal has a strong market position in the region and recorded sales in 2012 in excess of $11 million in Latin America with Mexico and Brazil generating two-thirds of the revenues. Bayer will provide certain distribution support services for an interim period.

During the quarter, Paladin added to its prescription and OTC portfolio with the launch of Silenor and Amniosense. Silenor is indicated for the treatment and symptomatic relief of insomnia and competes in the Canadian prescription sleep aid market which in 2012 was valued at over $90 million(3). In addition, Paladin's OTC portfolio was expanded with the launch of Amniosense, Canada's first and only OTC amniotic fluid leak detection test.

During the second quarter, Paladin expanded its product pipeline with the in-licensing of Urocidin and the NDA for Impavido. Paladin entered into an exclusive license to market and sell Bioniche's phase III bladder cancer treatment Urocidin in Canada, South Africa and Mexico. Furthermore, Paladin submitted a NDA to the FDA for Impavido and was granted priority review status. If approved, Paladin will be authorized to commercialize Impavido in the U.S. and will receive a priority review voucher through the FDA's tropical disease priority review voucher program.

Corporate Developments

During the quarter, Paladin entered into a strategic agreement with Bioniche to refinance and increase its debt for up to US $30 million, provide new equity of up to $0.5 million and license Urocidin. Paladin acquired Bioniche's existing secured debt facility with Capital Royalty Partners II L.P. and its affiliates for approximately US $22 million. In addition, Paladin and Bioniche entered into an amended secured loan transaction whereby Paladin provided an additional US $8 million loan to Bioniche, US $5 million of which was paid upon closing and the remaining US $3 million will be available upon meeting certain conditions. The loan bears an interest rate of 13.25% and will mature on July 1, 2014. Furthermore, Paladin was granted warrants to acquire up to 2 million common shares of Bioniche, in addition to another 1 million warrants which may be issued to Paladin under certain conditions.

Paladin also amended its existing loan agreement with Nuvo and issued a second tranche of $4 million bearing an interest rate of 15%. The amendment includes a third $4 million tranche which may be drawn upon achieving certain conditions, the issuance of up to 100,000 warrants to acquire Nuvo common shares and the right to in-license WF10, Nuvo's immune modulation drug candidate, if certain conditions are met.

During the second quarter, Paladin issued a combined balance of $4.2 million in secured loans to two additional unnamed pharmaceutical companies. Paladin also entered into a license agreement for certain intellectual property and related technology of Labopharm Inc. to Altus Formulation Inc. ("Altus") in exchange for a 35% equity ownership interest, option to in-license and royalty rights on future products developed by Altus.

Subsequent to the quarter, Paladin acquired Allon which was restructured under the Bankruptcy and Insolvency Act (Canada) and under the Canada Business Corporations Act. All pre-existing issued and outstanding shares and other securities of Allon were, pursuant to the Court Order, cancelled without payment or other consideration.

(1) EBITDA - Non-IFRS Financial Measures

The term EBITDA (earnings before interest, taxes, depreciation and amortization) does not have any standardized meaning under International Financial Reporting Standards ("IFRS") and therefore may not be comparable to similar measures presented by other companies. The Company defines EBITDA as earnings before interest expense, other expense (income), taxes, depreciation and amortization, foreign exchange gains (losses), share of net income (loss) in associates and joint venture and unusual items; such as write-downs and gains (losses) on intellectual property and investments. EBITDA is calculated and presented consistently from period to period and agrees, on a consolidated basis, with the amount disclosed as "Earnings before under-noted items" on the consolidated statements of income. The Company believes EBITDA to be an important measurement that allows it to assess the operating performance of its ongoing business on a consistent basis without the impact of amortization expenses. The Company excludes amortization expenses because their level depends substantially on non-operating factors such as the historical cost of intangible assets. The Company's method for calculating EBITDA may differ from that used by other issuers and, accordingly, this measure may not be comparable to EBITDA used by other issuers.

(3)

IMS Brogan - moving annual total for the 12 months ended December 31, 2012

(2)Adjusted

The term "adjusted" refers to the proportionate consolidation of Litha and Ativa's results. Given that Litha and Ativa are being accounted for on a consolidated basis, the consolidated results include amounts attributable to minority shareholders. Consequently, adjusted results have been provided to highlight Paladin's 44.54% and 50.01% economic interest in Litha and Ativa, respectively.

Conference Call Notice

Paladin will host a conference call to discuss its second quarter results today at 10:00 a.m. EST. The dial-in number for the conference call is 1-800-736-4610 or 416-981-9000. The call will be audio-cast live and archived for 30 days at www.paladinlabs.com.

About Paladin Labs Inc.

Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian and select international markets. With this strategy, a focused Canadian national sales team and proven marketing expertise, Paladin has evolved into one of Canada's leading specialty pharmaceutical companies. For more information, please visit the Company's web site at www.paladinlabs.com.

This press release may contain forward-looking statements and predictions. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. The Company considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but cautions that these assumptions regarding the future events, many of which are beyond the control of the Company and its subsidiaries, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations, are discussed in the annual report as well as in the Company's Annual Information Form for the year ended December 31, 2012. The Company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information or future events and except as required by law. For additional information on risks and uncertainties relating to these forward-looking statements, investors should consult the Company's ongoing quarterly filings, annual report and Annual Information Form and other fillings found on SEDAR at www.sedar.com.

INTERIM CONSOLIDATED BALANCE SHEETS

(In thousands of Canadian dollars)

As at

June 30, 2013

December 31, 2012

ASSETS

Current

Cash and cash equivalents

93,400

118,744

Marketable securities

160,096

146,258

Trade and other receivables

42,934

38,587

Inventories

43,136

37,441

Financial assets

988

-

Income tax receivable

533

5,479

Other current assets

2,171

1,661

Total current assets

343,258

348,170

Investment in associates

696

626

Interest in a joint venture

26,860

30,476

Loans receivable from a joint venture

11,027

11,661

Financial assets

32,534

4,561

Investment tax credits recoverable

22,647

24,840

Deferred income tax assets

21,959

25,402

Property, plant and equipment

8,499

9,754

Intangible assets

119,764

112,851

Goodwill

33,314

36,176

Total assets

620,558

604,517

LIABILITIES AND EQUITY

Current

Bank overdraft

5,790

7,044

Payables, accruals and provisions

56,266

50,165

Current portion of finance lease liability

745

796

Deferred revenue

3,894

2,734

Income tax payable

24,780

24,140

Other balances payable

2,000

2,000

Current portion of long-term liabilities

5,349

5,804

Total current liabilities

98,824

92,683

Finance lease liability

6,201

6,843

Deferred revenue

1,502

1,734

Deferred tax liability

21,359

24,415

Other balances payable

714

-

Long-term liabilities

23,900

28,327

Total liabilities

152,500

154,002

Equity

Share capital

176,964

172,282

Other paid-in capital

6,860

7,039

Other capital reserves

(10,069

)

(4,076

)

Retained earnings

232,861

208,461

Attributable to shareholders of the Company

406,616

383,706

Non-controlling interests

61,442

66,809

Total equity

468,058

450,515

Total liabilities and equity

620,558

604,517

INTERIM CONSOLIDATED INCOME STATEMENTS

(In thousands of Canadian dollars except for share and per share amounts)

Three months ended
June 30

Six months ended
June 30

2013

2012

2013

2012

Revenues

67,216

37,136

136,176

75,693

Cost of sales

26,127

9,981

54,535

21,169

Gross income

41,089

27,155

81,641

54,524

Expenses (income)

Selling, general and administrative

15,958

9,044

32,760

16,688

Research and development

2,162

1,879

4,787

4,427

Interest income

(1,898

)

(993

)

(3,384

)

(1,889

)

Earnings before under-noted items

24,867

17,225

47,478

35,298

Amortization of intangible assets

4,884

2,903

9,936

5,806

Depreciation of property, plant and equipment

305

26

647

51

Other finance expense

841

340

783

895

Other income

(36

)

(717

)

(549

)

(917

)

Foreign exchange (gain) loss

(953

)

192

(402

)

38

Interest expense

818

14

1,859

16

Share of net (income) loss from a joint venture

(157

)

-

859

-

Share of net income from an associates

(98

)

(524

)

(89

)

(949

)

Income before income tax

19,263

14,991

34,434

30,358

Provision for income taxes

4,856

4,113

9,477

8,158

Net income for the period

14,407

10,878

24,957

22,200

Attributable to:

Shareholders of the Company

13,621

10,878

24,400

22,200

Non-controlling interests

786

-

557

-

Attributable to shareholders of the Company

Basic earnings per share

0.66

0.54

1.19

1.09

Diluted earnings per share

0.64

0.52

1.16

1.06

Weighted number of shares outstanding

Basic

20,574,460

20,331,736

20,511,366

20,308,241

Diluted

21,127,270

20,926,103

21,080,176

20,992,924

INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands of Canadian dollars)

Three months ended June 30

Six months ended June 30

2013

2012

2013

2012

Operating activities

Net income for the period

14,407

10,878

24,957

22,200

Adjustments reconciling net income to operating cash flows

Amortization of intangible assets

4,884

2,903

9,936

5,806

Deferred tax

773

2,985

4,130

7,358

Share-based compensation expense

1,197

746

1,741

1,327

Other finance expense

841

340

783

895

Other income

(36

)

(717

)

(549

)

(717

)

Unrealized foreign exchange (gain) loss

(2,292

)

165

(2,188

)

230

Depreciation of property, plant and equipment

353

29

730

56

Share of net income from associates

(98

)

(524

)

(89

)

(949

)

Share of net (income) loss from a joint venture

(157

)

-

859

-

19,872

16,805

40,310

36,206

Net change in non-cash balances related to operations

(139

)

(5,165

)

1,096

(9,683

)

Cash inflow from operating activities

19,733

11,640

41,406

26,523

Investing activities

Disposals and maturities of marketable securities

33,388

75,656

69,834

115,163

Dividends from an associate

-

1,637

-

1,637

Proceeds from disposal of financial assets

33

799

68

799

Proceeds from disposal of intangible assets

50

717

50

717

Acquisition of subsidiaries, net of cash acquired

-

-

9

-

Purchases of marketable securities

(31,736

)

(40,478

)

(83,731

)

(77,055

)

Purchases of financial assets

(26,908

)

(4,000

)

(29,408

)

(4,000

)

Purchases of intangible assets

(22,565

)

(25

)

(23,680

)

(25

)

Purchases of property, plant and equipment

(167

)

(106

)

(332

)

(123

)

Payment of other balances payable

-

(995

)

-

(995

)

Net cash (outflow) inflow from investing activities

(47,905

)

33,205

(67,190

)

36,118

Financing activities

Common shares issued for cash

967

598

3,420

1,169

Increase (decrease) in bank overdraft

2,436

-

(727

)

-

Repurchase of shares

-

(1,458

)

-

(2,277

)

Repayment of long-term liabilities

(1,070

)

-

(2,188

)

-

Payment of obligation under finance lease

-

(250

)

-

(500

)

Net cash inflow (outflow) from financing activities

2,333

(1,110

)

505

(1,608

)

Foreign exchange rate loss on cash and cash equivalents

(42

)

(55

)

(65

)

(66

)

(Decrease) increase in cash and cash equivalents during the period

(25,881

)

43,680

(25,344

)

60,967

Cash and cash equivalents, beginning of period

119,281

89,402

118,744

72,115

Cash and cash equivalents, end of period

93,400

133,082

93,400

133,082

Paladin cash and cash equivalents

90,107

133,082

Paladin marketable securities

160,096

128,077

Paladin cash, cash equivalents and marketable securities

250,203

261,159

Litha cash and cash equivalents

2,846

-

Litha bank overdraft

(5,790

)

-

Litha cash and cash equivalents and bank overdraft

(2,944

)

-

Ativa cash and cash equivalents

447

-

Cash, cash equivalents and marketable securities net of bank overdraft

247,706

261,159

Reconciliation of the adjusted(2) consolidated results from operations

Three months ended June 30, 2013

Paladin

Litha & Ativa

Consolidated results from operations

Paladin

Litha & Ativa (proportionate consolidation)

Adjusted(2) consolidated results from operations

$

$

$

$

$

$

Revenues

40,376

26,840

67,216

40,376

11,955

52,331

Cost of sales

11,348

14,779

26,127

11,348

6,583

17,931

Gross Income

29,028

12,061

41,089

29,028

5,372

34,400

EBITDA(1)

20,928

3,939

24,867

20,928

1,751

22,679

Net income before income taxes

17,803

1,460

19,263

17,803

645

18,448

Net Income

13,016

1,391

14,407

13,016

615

13,631

Net Income attributable to shareholders


13,016


605


13,621


13,016


605


13,620

Six months ended June 30, 2013

Paladin

Litha & Ativa

Consolidated results from operations

Paladin

Litha & Ativa (proportionate consolidation)

Adjusted(2) consolidated results from operations

$

$

$

$

$

$

Revenues

79,036

57,140

136,176

79,036

25,451

104,487

Cost of sales

22,190

32,345

54,535

22,190

14,407

36,597

Gross Income

56,846

24,795

81,641

56, 846

11,044

67,890

EBITDA(1)

39,813

7,665

47,478

39,813

3,409

43,222

Net income before income taxes

32,786

1,648

34,434

32,786

724

33,510

Net Income

23,864

1,093

24,957

23,864

478

24,342

Net Income attributable to shareholders


23,864


536


24,400


23,864


536


24,400

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