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

On:  Wednesday, 8/5/15, at 4:07pm ET   ·   For:  8/5/15   ·   Accession #:  882104-15-49   ·   File #:  0-19756

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

 8/05/15  PDL Biopharma, Inc.               8-K:2,7,9   8/05/15    4:2.6M

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     61K 
 3: EX-99.2     Presentation                                        HTML      7K 
 4: EX-99.3     Information Sheet                                   HTML    145K 


EX-99.3   —   Information Sheet


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



  PDLI-2015.08.05-8-K EX 99.3  

Exhibit 99.3

PDL BioPharma, Inc.
Q2 2015
August 5, 2015

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

Net Income
Net income in the second quarter of 2015 was $78.3 million, or $0.47 per diluted share as compared with net income in the second quarter of 2014 of $92.1 million, or $0.52 per diluted share.

ARIAD Revenue Interest Assignment
On July 28, 2015, the Company entered into a revenue interest assignment agreement (the “Agreement”) in which it agreed to provide ARIAD Pharmaceuticals, Inc. ("ARIAD") with up to $200 million in cash in exchange for royalties on the net revenues of Iclusig® (ponatinib). Funding of the first $100 million will be made in two tranches of $50 million each, with the initial amount having already been funded on the closing date of the Agreement and an additional $50 million to be funded on the 12-month anniversary of the closing date. In addition, ARIAD has an option to draw up to an additional $100 million at any time between the six and twelve month anniversaries of the closing date.

PDL will initially receive 2.5% of the worldwide net revenues of Iclusig until the 12-month anniversary of the closing date, at which time the royalty increases to 5.0% of the worldwide net revenues of Iclusig and remains until December 31, 2018.  Beginning January 1, 2019 and thereafter, the royalty rate will increase to 6.5%, subject to an additional increase to 7.5% if PDL’s funding exceeds $150 million.

If PDL does not receive payments equal to or greater than the total amount funded on or before the fifth anniversary of each of the respective fundings, ARIAD will pay PDL make-whole payments calculated as the difference between the amounts funded by PDL and the amounts paid to PDL to such date. In addition, if the net revenues from Iclusig do not reach certain agreed-upon projections in future years, PDL has a right to the same percentage of net revenues from brigatinib.

PDL has a put option based upon certain events and ARIAD has a call option to repurchase the revenue interest at any time.  The financial terms for the put and call are the same: the greater of a 10% IRR or 1.5 times cash-on-cash in year one, 1.2 times cash-on-cash in year two and 1.3 times cash-on-cash in year three and beyond.

Updates on Approved Royalty Bearing Products related to Queen et al. patents

Avastin® (bevacizumab):
On July 23, 2015, Genentech/Roche reported that 1H15 worldwide sales were CHF 3.263 billion and increased by 9%.
EU: Growth driven by ovarian and cervical cancer, the latter of which was approval in 1Q15.
US: Sales largely driven by ovarian, cervical and first line colorectal cancer.
Japan: Growth in all indications.
International: Strong growth in all regions, especially Latin America.

Herceptin® (trastuzumab):
On July 23, 2015, Genentech/Roche reported that 1H15 worldwide sales were CHF 3.265 billion and increased by 11%.
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 all regions.

Xolair® (omalizumab):
On July 23, 2015, Genentech/Roche reported that 1H15 US sales were CHF 593 million and increased by 28%.
Growth in allergic asthma and chronic idiopathic urticaria (hives).
On July 21, 2015, Novartis reported that 2Q15 ex-US sales were $194 million and increased by 18%.


Page 1

PDL BioPharma, Inc.
Q2 2015
August 5, 2015



Tysabri® (natalizumab):
On July 24, 2015, Biogen reported that 2Q15 worldwide sales were $463 million, flat from 1Q15 but decreased by 13% from 2Q14.

Perjeta® (pertuzumab):
On July 23, 2015, Genentech/Roche reported that 1H15 worldwide sales were CHF 659 million and increased by 72%.
Perjeta sales grew in all regions, driven by US in the neoadjuvant and metastatic breast cancer settings, and EU in the metastatic breast cancer setting.
Approved in all major markets for first line metastatic breast cancer.
Approved in US and 20 markets for neoadjuvant setting with positive CHMP opinion in neoadjuvant setting in 1Q15.
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.

Kadcyla® (TDM-1 or ado-trastuzumab emtansine):
On July 23, 2015, Genentech/Roche reported that 1H15 worldwide sales were CHF 362 million and increased by 65%.
EU and International: Strong uptake in second line metastatic breast cancer.
Data expected from Phase 2/3 trial in HER2+ gastric cancer (GATSBY) in 2H15.

Updates on Unapproved Royalty Bearing Products Related to Queen et al. patents

Solanezumab
On July 22, 2015 at a healthcare conference focused on Alzheimer’s Disease, Lilly presented two year data from an extension study of two earlier Phase 3 studies of solanezumab. These studies included patients with mild and moderate Alzheimer’s Disease, and while they did not meet the primary efficacy endpoint, they did show benefit in patients with mild disease. The two year extension study utilized a delayed start analysis. The new data suggest that patients who started solanezumab earlier retained an advantage in cognition and daily function over those who started later and that the difference persisted for two years. Lilly commenced a new Phase 3 trial in patients with only mild Alzheimer's Disease in 2013. On April 23, 2015, Lilly stated that this Phase 3 trial was fully enrolled with the last patient visit expected in 4Q16 and topline results thereafter. Because of the difficulty in distinguishing between patients with dementia and those with Alzheimer's Disease, Lilly used PET scans or similar screens to test patients before enrolling them in this new Phase 3 trial. The screens differentiate between patients with beta amyloid buildup = Alzheimer's Disease and who should be in the trial versus those without beta amyloid buildup = dementia and who should not be in the trial. Lilly estimates that scans will increase patient enrollment failures from less than 25% to more than 50% - a good thing because it enriches the patient population with those most likely to benefit from solanezumab. PDL has a know-how royalty on solanezumab which extends beyond the expiration of the Queen patents. This is because PDL helped to design solanezumab. If solanezumab is approved, PDL would receive a 2% royalty for 12.5 years from the date of its first sale.

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 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 2

PDL BioPharma, Inc.
Q2 2015
August 5, 2015



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

38,447



77,256

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

39,476



77,351

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

11,075



22,046

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

7,419



14,015

2014
3,375

4,385

5,157

5,850

18,767

2013
340

1,414

748

879

3,381

2012


58

250

308


Page 3

PDL BioPharma, Inc.
Q2 2015
August 5, 2015



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

4,177



8,029

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

13,614



27,999

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 4

PDL BioPharma, Inc.
Q2 2015
August 5, 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

1,809,286



3,635,575

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

1,857,696



3,647,100

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

521,192



1,044,532

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

349,125



659,535

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 5

PDL BioPharma, Inc.
Q2 2015
August 5, 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

196,556



377,831

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

453,786



933,312

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 6

Dates Referenced Herein   and   Documents Incorporated by Reference

This ‘8-K’ Filing    Date    Other Filings
1/1/19
12/31/18
Filed on / For Period End:8/5/15
7/28/158-K
7/24/15
7/23/15
7/22/15
7/21/15
4/23/158-K
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