PDL BIOPHARMA, INC. - FORM 8-K - EX-99.3 - INFORMATION SHEET - November 10, 2014

Attached files

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8-K - 8-K - PDL BIOPHARMA, INC.pdli-201411108xkdoc.htm
EX-99.2 - PRESENTATION - PDL BIOPHARMA, INC.pdli-201411108xkex992.htm
EX-99.1 - PRESS RELEASE - PDL BIOPHARMA, INC.pdli-201411108xkex991.htm

Exhibit 99.3

PDL BioPharma, Inc.
Q3 2014
November 10, 2014

Following are some of the key points regarding PDL’s third quarter 2014 financial and business results.

Net Income
Net income in the third quarter of 2014 was $102.2 million, or $0.61 per diluted share, as compared with net income in the third quarter of 2013 of $56.2 million, or $0.36 per diluted share. Net income for the first nine months of 2014 was $267.2 million, or $1.62 per diluted share, as compared with net income in the first nine months of 2013 of $203.4 million, or $1.31 per diluted share.

Royalty Acquisition
On November 6, 2014, PDL acquired a portion of all royalty payments of the University of Michigan’s (“U-M”) worldwide royalty interest in Cerdelga™ (eliglustat) for $65.6 million. Under the terms of the royalty agreement, PDL will receive 75 percent of all royalty payments due under U-M’s license agreement with Genzyme until expiration of the licensed patents, excluding any patent term extension. Cerdelga, an oral therapy for adult patients with Gaucher disease type 1, was developed by Genzyme, a Sanofi company. Cerdelga was approved by the U.S. Food and Drug Administration (FDA) on August 19, 2014. In addition to the recent FDA approval, marketing applications for Cerdelga are under review by the European Medicines Agency and other regulatory authorities.

2014 Dividends
On January 29, 2014, PDL’s Board of Directors declared regular quarterly dividends of $0.15 per share of common stock, payable on March 12, June 12, September 12 and December 12 of 2014 to all stockholders who own shares of PDL on March 5, June 5, September 5 and December 5 of 2014, the record dates for each of the dividend payments, respectively. On September 12, 2014, PDL paid the third quarterly dividend to stockholders of record totaling $24.0 million using earnings generated in the third quarter of 2014.

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

Avastin® (bevacizumab):
•
On October 16, 2014, Genentech/Roche reported that YTD worldwide sales were CHF 4.749 billion and increased by 6%.
◦
EU: Strong growth driver by further uptake in ovarian and breast cancer.
◦
US: Continued increase in metastatic colorectal cancer.
◦
Japan: Increased demand in colorectal, breast and ovarian cancers as well as glioblastoma.
◦
International: Launches for ovarian cancer and uptake in colorectal cancer.
•
On August 14, 2014, Genentech announced US approval for the treatment of persistent, recurrent or metastatic cervical cancer in combination with chemotherapy.
•
On July 21, 2014, Genentech announced that its application for approval for the treatment of recurrent platinum-resistant ovarian cancer in US had been granted priority review with a PDUFA date of November 19, 2014.
•
On August 6, 2014, Roche reported EU approval for the treatment of ovarian cancer that is resistant to platinum-based chemotherapy.

Herceptin® (trastuzumab):
•
On October 16, 2014, Genentech/Roche reported that YTD worldwide sales were CHF4.679 billion and increased by 7%.
◦
Positive growth in all regions driven by higher volumes/prolonged treatment times.
◦
US: Continued growth in first line metastatic HER2+ breast cancer.
◦
EU: Strong demand in Germany, Spain and UK.
◦
Japan: Increased usage in combination with Perjeta in HER2+ breast cancer, as well in gastric cancer.
◦
International: Growth driven by China and Brazil.

Lucentis® (ranibizumab):
•
On Oct. 16, 2014, Genentech/Roche reported that YTD US sales were CHF1.260 billion and increased by 5%.
•
On October 28, 2014, Novartis reported that 3Q14 ex-US sales were $614 million and increased by 7%.

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PDL BioPharma, Inc.
Q3 2014
November 10, 2014


•
On August 7, 2014, Genentech filed in US for approval for treatment of diabetic retinopathy.
◦
Diabetic retinopathy is the leading cause of new cases of blindness of working-age people.
•
October 17, 2014, Regeneron announced top line results from a three-arm trial comparing its drug Eylea with Avastin and Lucentis in patients with diabetic macular edema which showed a greater change in best corrected visual acuity in patients treated with Eylea compared those treated with either Avastin or Lucentis.

Xolair® (omalizumab):
•
On October 16, 2014, Genentech/Roche reported that YTD US sales were CHF 701 million and increased by 24%.
•
On October 28, 2014, Novartis reported that 3Q14 ex-US sales were $207 million and increased by 39%.
•
In March 2014, both Genentech/Roche and Novartis reported US and EU had approvals, respectively, for treatment of chronic idiopathic urticaria.
•
On September 26, 2014, FDA updated the label to warn about a slightly increased risk of cardiovascular and cerebrovascular events as well as a potential risk of cancer.

Tysabri® (natalizumab):
•
On October 22, 2014, Biogen Idec reported that 3Q14 worldwide sales were $501 million.

Actemra® (tocilizumab):
•
On October 16, 2014, Genentech/Roche reported that YTD worldwide sales were CHF 897 million and increased by 24% year over year.
◦
EU: Continued growth driven by strong monotherapy patient shares in all lines with encouraging subcutaneous adoption.
◦
US: Growth is driven by strong IV demand and subcutaneous patient share uptake (~80% of new patients).
◦
Subcutaneous formulation approved in US and EU in October 2013 and April 2014, respectively.
•
On September 8, 2014, Roche announced EU approval for treatment of patients with early rheumatoid arthritis.

Perjeta® (pertuzumab):
•
On October 16, 2014, Genentech/Roche reported YTD worldwide sales were CHF 633 million and increased by 255% year over year.
◦
Growth driven by continued strong uptake in first and second line metastatic HER2+ breast cancer and in the neoadjuvant setting in the US.
•
On September 28, 2014, Genentech/Roche announced that final data from Phase 3 study in patients with previously untreated HER2+ metastatic breast cancer who were treated with Perjeta, Herceptin and docetaxel lived a median of 56.5 months compared to 40.8 months for patients treated with Herceptin and docetaxel. Median overall survival of almost five years is the longest observed to date in patients with metastatic HER2+ breast cancer.

Kadcyla® (TDM-1 or ado-trastuzumab emtansine):
•
On October 16, 2014, Genentech/Roche reported YTD worldwide sales were CHF 371 million and increased by 148%.
◦
Strong uptake in second line metastatic HER2+ breast cancer.
•
MARIANNE results expected in 4Q14.

Gazyva™ (Obinutuzumab or GA101):
•
On October 16, 2014, Genentech/Roche announced YTD worldwide sales of CHF 32 million.
•
Gazyva was approved in the US on November 1, 2013, for previously untreated chronic lymphocytic leukemia (CLL) in combination with chlorambucil.
•
On July 29, 2014, Roche announced EU approval for first line treatment of CLL with chlorambucil.

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PDL BioPharma, Inc.
Q3 2014
November 10, 2014



Updates on Acquired Royalties from Depomed

•
Current royalty bearing products include:
◦
Glumetza (U.S, sold by Santarus / Salix)
◦
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)
•
Since inception of the transaction (October 2013) to date we have received $93.7 million in cash from this transaction, which includes $82.5 million in cash for the year to date September 30, 2014.

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.


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PDL BioPharma, Inc.
Q3 2014
November 10, 2014


Queen et al. Royalty Revenue by Product ($ in 000's) *
Avastin
Q1
Q2
Q3
Q4
Total
2014
38,122

38,924

38,864

—

115,910

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
2014
36,646

38,292

39,407

—

114,345

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
2014
17,390

16,777

16,883

—

51,050

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
2014
8,886

9,099

10,442

—

28,427

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
2014
3,375

4,385

5,157

—

12,917

2013
340

1,414

748

879

3,381

2012
—

—

58

250

308


Page 4
PDL BioPharma, Inc.
Q3 2014
November 10, 2014


Queen et al. Royalty Revenue by Product ($ in 000's) *
Kadcyla
Q1
Q2
Q3
Q4
Total
2014
1,934

2,491

3,048

—

7,473

2013
—

551

830

859

2,240

 
 
 
 
 
 
Tysabri
Q1
Q2
Q3
Q4
Total
2014
12,857

13,350

16,048

—

42,255

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
2014
3,446

3,932

4,419

—

11,797

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

2006
—

—

—

—

—

 
 
 
 
 
 
Gazyva
Q1
Q2
Q3
Q4
Total
2014
51

283

325

—

659

 
 
 
 
 
 
Entyvio
Q1
Q2
Q3
Q4
Total
2014
—

—

153

—

153

 
 
 
 
 
 
* 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.
Q3 2014
November 10, 2014


Queen et al. Reported Net Sales Revenue by Product ($ in 000's) *
Avastin
Q1
Q2
Q3
Q4
Total
2014
1,786,912

1,838,764

1,828,900

—

5,454,576

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
2014
1,731,564

1,801,990

1,854,452

—

5,388,006

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
2014
818,376

789,483

794,503

—

2,402,362

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
2014
425,243

428,171

491,372

—

1,344,786

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
2014
158,809

206,333

242,700

—

607,842

2013
34,008

55,076

66,353

87,949

243,386

2012
—

—

5,080

25,000

30,079


Page 6
PDL BioPharma, Inc.
Q3 2014
November 10, 2014


Queen et al. Reported Net Sales Revenue by Product ($ in 000's) *
Kadcyla
Q1
Q2
Q3
Q4
Total
2014
91,031

117,212

143,414

—

351,657

2013
—

21,459

73,626

85,906

180,991

 
 
 
 
 
 
Tysabri
Q1
Q2
Q3
Q4
Total
2014
428,561

442,492

534,946

—

1,405,999

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
2014
114,865

124,736

147,285

—

386,886

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
2014
3,095

8,697

11,531

—

23,323

 
 
 
 
 
 
Entyvio
Q1
Q2
Q3
Q4
Total
2014
—

—

5,347

—

5,347

 
 
 
 
 
 
* As reported to PDL by its licensee
 
   Totals may not sum due to rounding
 
 


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PDL BIOPHARMA, INC. Reports