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PDL Biopharma, Inc. – ‘8-K’ for 5/6/15 – EX-99.3

On:  Wednesday, 5/6/15, at 4:03pm ET   ·   For:  5/6/15   ·   Accession #:  882104-15-30   ·   File #:  0-19756

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  As Of                Filer                Filing    For·On·As Docs:Size

 5/06/15  PDL Biopharma, Inc.               8-K:2,7,9   5/06/15    4:2.1M

Current Report   —   Form 8-K
Filing Table of Contents

Document/Exhibit                   Description                      Pages   Size 

 1: 8-K         Current Report                                      HTML     20K 
 2: EX-99.1     Press Release                                       HTML     46K 
 3: EX-99.2     Presentation                                        HTML      6K 
 4: EX-99.3     Information Sheet                                   HTML    149K

EX-99.3   —   Information Sheet

This exhibit is an HTML Document rendered as filed.  [ Alternative Formats ]

  PDLI-2015.05.06-8-K EX 99.3  

Exhibit 99.3

PDL BioPharma, Inc.
Q1 2015
May 6, 2015

Following are some of the key points regarding PDL’s first quarter 2015 financial and business results.

Net Income
Net income in the first quarter of 2015 was $84.5 million, or $0.50 per diluted share, as compared with net income of $72.9 million in the first quarter of 2014, or $0.44 per diluted share.
Updates on Approved Royalty Bearing Products related to Queen et al. patents

Avastin® (bevacizumab):
•
On April 22, 2015, Genentech/Roche reported that 1Q15 worldwide sales were CHF 1.61 billion and increased by 6%.
◦
EU: Growth driven by further uptake in ovarian and breast cancer.
◦
US: Sales largely driven by cervical, ovarian and lung cancer.
◦
Japan: Growth in all indications.
◦
International: Strong growth in all regions.
•
On August 14, 2014 and April 8, 2015, Genentech/Roche announced US and EU approval for the treatment of persistent, recurrent or metastatic cervical cancer in combination with chemotherapy, respectively.
•
On August 6, 2014 and November 14, 2014, Genentech/Roche announced EU and US approval for the treatment of recurrent platinum-resistant ovarian cancer, respectively.

Herceptin® (trastuzumab):
•
On April 22, 2015, Genentech/Roche reported that 1Q15 worldwide sales were CHF 1.652 billion and increased by 12%.
◦
US: Strong growth in first line metastatic breast cancer due to longer treatment times.
◦
EU: Stable sales with continuing conversion to subcutaneous formulation.
◦
International: Strong growth in Latin America due to access to public markets and in China due to patient assistance program.

Lucentis® (ranibizumab):
•
On April 23, 2015, Novartis reported that 1Q15 ex-US sales were $539 million and were flat.

Xolair® (omalizumab):
•
On April 22, 2015, Genentech/Roche reported that 1Q15 US sales were CHF 281 million and increased by 28%.
◦
Growth in asthma and chronic idiopathic urticaria (hives) post-FDA approval in 1Q14.
•
On April 23, 2015, Novartis reported that 1Q15 ex-US sales were $180 million and increased by 22%.

Tysabri® (natalizumab):
•
On April 24, 2015, Biogen reported that 1Q15 worldwide sales were $463 million and increased by 5%.

Actemra® (tocilizumab):
•
On April 22, 2015, Genentech/Roche reported that 1Q15 worldwide sales were CHF 334 million and increased by 27%.
◦
EU: Strong uptake in first line monotherapy and subcutaneous launch.
◦
US: Over 35% growth driven by continued uptake of new subcutaneous formulation.
◦
International: Over 55% growth driven by all regions, especially Latin America.

Perjeta® (pertuzumab):
•
On April 22, 2015, Genentech/Roche reported that 1Q15 worldwide sales were CHF 322 million and increased by 82%.

Page 1
PDL BioPharma, Inc.
Q1 2015
May 6, 2015



◦
Perjeta sales grew in all regions with strong uptake in the US, Germany and France.
◦
Benefiting from increase in overall survival in first line metastatic breast cancer when combined with Herceptin and docetaxel which data was added to US label in 1Q15 and neoadjuvant indication approved in US and 17 countries.

Kadcyla® (TDM-1 or ado-trastuzumab emtansine):
•
On April 22, 2015, Genentech/Roche reported that 1Q15 worldwide sales were CHF 179 million and increased by 80%.
•
EU: Strong uptake in second line metastatic breast cancer.
•
On December 18, 2014, Genentech reported that the two Kadcyla arms in MARIANNE trial in first line metastatic breast cancer failed to demonstrate superiority over Herceptin + chemotherapy. This does not affect its current approval as second line treatment for HER2+ metastatic breast cancer.

Solanezumab
•
On April 23, 2015, Lilly stated that its new Phase 3 trial in patients with mild Alzheimer’s Disease is fully enrolled with the last patient visit expected in October 2016 and topline results thereafter.
•
Lilly also stated that two year data from the extension of its earlier Phase 3 Expedition trials in patients with mild-to-moderate Alzheimer’s Disease will be available in the middle of this year, that disease modification is the focus of the dataset and that they will break out patients with mild disease in the analysis.
◦
Unlike in the new Phase 3, Lilly did not use PET scans or similar tests to screen potential trial enrollees for beta amyloid build up.
•
If solanezumab were to receive marketing authorization, PDL would receive a 12.5 year know-how royalty of 2% from date of first sale.

Updates on Acquired Royalties from Depomed
•
Effective April 1, 2015 Valeant Pharmaceuticals International, Inc. completed its acquisition of Salix Pharmaceuticals.
•
Current royalty bearing products include:
◦
Glumetza (U.S, sold by Salix/Valeant Pharmaceuticals)
◦
Glumetza (Canada, sold by Valeant Pharmaceuticals)
◦
Glumetza (Korea, sold by LG Life Sciences)
◦
Janumet XR (world-wide, Sold by Merck)
•
Additional products for which we may receive milestones and royalties:
◦
Combination of Invokana® (canagliflozin) and extended-release metformin (Janssen Pharmaceutica)
◦
Two investigational fixed-dose combinations of drugs and extended-release metformin (Boehringer Ingelheim)

•
In the first quarter of 2015 we recorded a $9.1 million increase in revenue related to the royalty rights- change in fair value of the Depomed asset, which included a net cash payment of approximately $0.5 million. PDL expects that the sales of Glumetza in the U.S., and therefore royalties on such sales paid to the Company, will be minimal through the second quarter of 2015 as distributors continue to reduce their excess levels of inventory of Glumetza.

•
Our forecast of $49 million in cash receipts in 2015 related to the Depomed transaction remains unchanged from estimates given in February of 2015.

•
Since inception of the transaction (October 2013) to date we have received $113.5 million in cash from this transaction.

Forward-looking Statements
This document contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from those, express or implied, in these forward-looking statements. Important factors that could impair the value of the Company's royalty assets, restrict or impede the ability of the Company to invest in new income generating assets and limit the Company's ability to pay dividends are disclosed in the risk factors contained in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission, as updated by subsequent filings. All forward-looking statements are

Page 2
PDL BioPharma, Inc.
Q1 2015
May 6, 2015



expressly qualified in their entirety by such factors. We do not undertake any duty to update any forward looking statement except as required by law.


Page 3
PDL BioPharma, Inc.
Q1 2015
May 6, 2015



Queen et al. Royalties
Royalty Revenue by Product ($ in 000's) *
Avastin
Q1
Q2
Q3
Q4
Total
2015
38,809

—

—

—

38,809

2014
38,122

38,924

38,864

40,723

156,632

2013
33,234

46,720

32,224

32,287

144,464

2012
23,215

41,670

25,955

30,041

120,882

2011
22,283

41,967

23,870

22,886

111,006

2010
16,870

44,765

29,989

24,922

116,547

2009
13,605

35,161

21,060

15,141

84,966

2008
9,957

30,480

19,574

12,394

72,405

2007
8,990

21,842

17,478

9,549

57,859

2006
10,438

15,572

15,405

12,536

53,952

Herceptin
Q1
Q2
Q3
Q4
Total
2015
37,875

—

—

—

37,875

2014
36,646

38,292

39,407

40,049

154,394

2013
30,287

47,353

30,961

33,038

141,640

2012
25,702

44,628

30,433

28,307

129,070

2011
25,089

42,209

31,933

21,812

121,042

2010
23,402

38,555

27,952

25,441

115,350

2009
16,003

32,331

26,830

18,615

93,779

2008
14,092

34,383

28,122

20,282

96,880

2007
19,035

28,188

22,582

14,802

84,608

2006
15,142

19,716

21,557

20,354

76,769

Lucentis
Q1
Q2
Q3
Q4
Total
2015
15,920

—

—

—

15,920

2014
17,390

16,777

16,883

16,695

67,746

2013
12,032

30,066

13,536

12,127

67,760

2012
10,791

27,938

12,552

11,097

62,377

2011
8,878

24,313

12,157

10,750

56,099

2010
7,220

19,091

10,841

8,047

45,198

2009
4,621

12,863

8,123

6,152

31,759

2008
3,636

11,060

7,631

4,549

26,876

2007
2,931

6,543

6,579

3,517

19,570

2006
—

—

289

3,335

3,624

Xolair
Q1
Q2
Q3
Q4
Total
2015
10,971

—

—

—

10,971

2014
8,886

9,099

10,442

11,237

39,663

2013
5,930

10,025

7,334

7,330

30,619

2012
5,447

8,609

6,504

6,145

26,705

2011
4,590

7,621

5,916

5,823

23,949

2010
3,723

6,386

4,980

4,652

19,741

2009
2,665

5,082

4,085

3,722

15,553

2008
1,488

4,866

3,569

2,927

12,850

2007
1,684

3,942

3,332

2,184

11,142

2006
2,263

2,969

3,041

2,495

10,768

Perjeta
Q1
Q2
Q3
Q4
Total
2015
6,596

—

—

—

6,596

2014
3,375

4,385

5,157

5,850

18,767

2013
340

1,414

748

879

3,381

2012
—

—

58

250

308


Page 4
PDL BioPharma, Inc.
Q1 2015
May 6, 2015



Queen et al. Royalties
Royalty Revenue by Product ($ in 000's) *
Kadcyla
Q1
Q2
Q3
Q4
Total
2015
3,852

—

—

—

3,852

2014
1,934

2,491

3,048

3,464

10,937

2013
—

551

830

859

2,240

Tysabri
Q1
Q2
Q3
Q4
Total
2015
14,385

—

—

—

14,385

2014
12,857

13,350

16,048

15,015

57,270

2013
12,965

13,616

11,622

12,100

50,304

2012
11,233

12,202

11,749

12,255

47,439

2011
9,891

10,796

11,588

11,450

43,725

2010
8,791

8,788

8,735

9,440

35,754

2009
6,656

7,050

7,642

8,564

29,912

2008
3,883

5,042

5,949

6,992

21,866

2007
839

1,611

2,084

2,836

7,370

2006
—

—

—

237

237

Actemra
Q1
Q2
Q3
Q4
Total
2015
4,990

—

—

—

4,990

2014
3,446

3,932

4,419

5,406

17,202

2013
2,631

2,816

2,939

3,744

12,131

2012
1,705

2,074

2,145

2,462

8,385

2011
913

1,136

1,401

1,460

4,910

2010
1,587

237

315

688

2,827

2009
585

537

909

1,197

3,228

2008
44

—

146

369

559

2007
32

—

—

17

49

Gazyva
Q1
Q2
Q3
Q4
Total
2015
313

—

—

—

313

2014
51

283

325

436

1,094

Entyvio
Q1
Q2
Q3
Q4
Total
2015
2,223

—

—

—

2,223

2014
—

—

153

2,192

2,344

* As reported to PDL by its licensees. Totals may not sum due to rounding.
Q1 2014 royalty revenue by product above do not include a $5 million payment received from Genentech in Q1 2014 for a retroactive settlement payment from 2013.



Page 5
PDL BioPharma, Inc.
Q1 2015
May 6, 2015




Queen et al. Sales Revenue
Reported Licensee Net Sales Revenue by Product ($ in 000's) *
Avastin
Q1
Q2
Q3
Q4
Total
2015
1,826,289

—

—

—

1,826,289

2014
1,786,912

1,838,764

1,828,900

1,916,353

7,370,929

2013
1,653,108

1,694,678

1,746,135

1,819,877

6,913,798

2012
1,502,757

1,573,727

1,551,327

1,662,977

6,290,788

2011
1,597,461

1,582,705

1,581,095

1,469,994

6,231,255

2010
1,506,788

1,596,892

1,594,707

1,646,218

6,344,605

2009
1,345,487

1,295,536

1,439,730

1,514,053

5,594,806

2008
980,715

1,084,930

1,180,427

1,239,382

4,485,454

2007
678,068

746,587

797,013

875,084

3,096,752

2006
439,318

516,052

570,551

592,897

2,118,817

Herceptin
Q1
Q2
Q3
Q4
Total
2015
1,789,404

—

—

—

1,789,404

2014
1,731,564

1,801,990

1,854,452

1,877,614

7,265,621

2013
1,681,574

1,744,145

1,681,860

1,726,551

6,834,130

2012
1,515,255

1,625,313

1,663,695

1,650,495

6,454,759

2011
1,391,568

1,559,975

1,642,898

1,432,771

6,027,211

2010
1,270,846

1,349,512

1,300,934

1,409,310

5,330,602

2009
1,210,268

1,133,993

1,226,435

1,278,626

4,849,323

2008
1,105,426

1,195,215

1,211,982

1,186,806

4,699,428

2007
891,761

949,556

979,602

1,015,033

3,835,952

2006
529,585

659,719

761,099

803,576

2,753,979

Lucentis
Q1
Q2
Q3
Q4
Total
2015
749,182

—

—

—

749,182

2014
818,376

789,483

794,505

785,669

3,188,031

2013
1,203,179

1,171,423

1,200,791

1,212,651

4,788,045

2012
1,079,092

1,086,543

1,097,541

1,109,695

4,372,871

2011
887,757

943,418

1,052,809

1,075,015

3,958,999

2010
721,967

698,890

745,376

804,684

2,970,917

2009
462,103

469,736

555,296

615,212

2,102,347

2008
363,615

393,682

460,167

454,922

1,672,386

2007
224,820

219,579

299,995

322,300

1,066,695

2006
—

—

10,689

157,742

168,431

Xolair
Q1
Q2
Q3
Q4
Total
2015
523,340

—

—

—

523,340

2014
425,243

428,171

491,372

521,726

1,866,512

2013
341,309

365,778

391,900

401,333

1,500,321

2012
310,234

314,638

347,796

340,431

1,313,100

2011
267,754

277,642

310,874

314,911

1,171,182

2010
228,859

225,878

251,055

263,389

969,179

2009
184,669

181,086

211,006

219,693

796,454

2008
137,875

169,521

177,179

183,753

668,329

2007
129,172

130,700

144,250

147,754

551,876

2006
95,241

99,354

112,608

118,002

425,204

Perjeta
Q1
Q2
Q3
Q4
Total
2015
310,410

—

—

—

310,410

2014
158,809

206,333

242,700

275,311

883,153

2013
34,008

55,076

66,353

87,949

243,386

2012
—

—

5,080

25,000

30,079


Page 6
PDL BioPharma, Inc.
Q1 2015
May 6, 2015



Queen et al. Sales Revenue
Reported Licensee Net Sales Revenue by Product ($ in 000's) *
Kadcyla
Q1
Q2
Q3
Q4
Total
2015
181,275

—

—

—

181,275

2014
91,031

117,212

143,414

163,028

514,685

2013
—

21,459

73,626

85,906

180,991

Tysabri
Q1
Q2
Q3
Q4
Total
2015
479,526

—

—

—

479,526

2014
428,561

442,492

534,946

500,511

1,906,510

2013
434,677

451,358

387,407

403,334

1,676,776

2012
374,430

401,743

391,623

408,711

1,576,508

2011
329,696

356,876

388,758

381,618

1,456,948

2010
293,047

287,925

293,664

316,657

1,191,292

2009
221,854

229,993

257,240

285,481

994,569

2008
129,430

163,076

200,783

233,070

726,359

2007
30,468

48,715

71,972

94,521

245,675

2006
—

—

—

7,890

7,890

Actemra
Q1
Q2
Q3
Q4
Total
2015
166,338

—

—

—

166,338

2014
114,865

124,736

147,285

180,197

567,082

2013
87,703

91,374

97,961

124,815

401,852

2012
56,662

66,624

71,505

82,053

276,843

2011
30,433

35,370

46,709

48,671

161,183

2010
52,908

5,405

10,493

22,919

91,725

2009
19,504

17,920

30,313

39,888

107,625

2008
1,452

1,377

5,981

12,305

21,115

2007
—

—

—

1,137

1,137

Gazyva
Q1
Q2
Q3
Q4
Total
2015
9,627

—

—

—

9,627

2014
3,095

8,697

11,531

13,428

36,750

Entyvio
Q1
Q2
Q3
Q4
Total
2015
59,287

—

—

—

59,287

2014
—

—

5,347

58,500

63,848

* As reported to PDL by its licensee. Dates in above charts reflect when PDL receives
royalties on sales. Sales occurred in the quarter prior to the dates in the above charts.
Totals may not sum due to rounding.
 


Page 7

Dates Referenced Herein   and   Documents Incorporated by Reference

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4/1/158-K
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8/6/148-K
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