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8-K - 8-K - PDL BIOPHARMA, INC.pdli-20131106x8xkdoc.htm
EX-99.2 - PRESENTATION - PDL BIOPHARMA, INC.pdli-20131106x8xkex992.htm
EX-99.1 - PRESS RELEASE - PDL BIOPHARMA, INC.pdli-20131106x8xkex991.htm

Exhibit 99.3

PDL BioPharma, Inc.
Q3-2013
November 6, 2013

Following are some of the key points regarding PDL’s third quarter 2013 financial and business results.
Net Income
Net income for the third quarter of 2013 was $56.2 million, or $0.36 per diluted share, as compared with net income of $48.6 million, or $0.32 per diluted share, in the same quarter of 2012. The increase in net income in the third quarter is primarily due to the 13 percent increase in royalty revenues.

2013 Dividends
On January 30, 2013, 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 2013 to all stockholders who own shares of PDL on March 5, June 5, September 5 and December 5 of 2013, the record dates for each of the dividend payments, respectively. On September 12, 2013, PDL paid the third quarterly dividend to stockholders of record totaling $21.0 million using earnings generated in the third quarter of 2013.

Four Recent Transactions

Debt Financing Provided to Direct Flow Medical, Inc.
On November 5, 2013, PDL entered into a debt financing transaction with Direct Flow Medical, Inc. (DFM), a transcatheter heart valve innovator focused on improving patient outcomes. PDL will provide a total of up to $50 million to DFM to be used to refinance its existing credit facility and fund the commercialization of its transcatheter aortic valve system used to treat aortic stenosis. An initial $35 million was provided at the close of the transaction, with the remaining $15 million to be funded upon the achievement of a specified revenue milestone.

Debt Financing Provided to Durata Therapeutics, Inc.
On October 31, 2013, PDL entered into a debt financing transaction with Durata Therapeutics, Inc. , a pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses. PDL will provide Durata with up to $70 million of debt financing to be used to refinance its existing credit facility and fund the commercialization of dalbavancin, an intravenous antibiotic product candidate, for the treatment of patients with acute bacterial skin and skin structure infections, or ABSSSI, caused by Gram-positive bacteria, such as S. aureus, including methicillin-resistant and multi-drug resistant strains, and certain streptococcal species. An initial $25 million was provided at the close of the transaction, with the remaining $45 million to be made available pending regulatory approval of dalbavancin.

Acquisition of Diabetes Royalty Rights and Milestones from Depomed, Inc.
On October 18, 2013, PDL acquired the rights to receive royalties and milestones payable on sales of Type 2 diabetes products licensed by Depomed in exchange for a $240.5 million cash payment. PDL will receive all royalty and milestone payments due under the agreements until it has received payments equal to two times the cash payment made to Depomed, after which all payments received will be shared evenly between PDL and Depomed. 

Debt Financing Provided to LENSAR, Inc.
On October 1, 2013, PDL entered into a credit agreement with LENSAR, Inc., a leader in the development and commercialization of a more intelligent solution for refractive laser-assisted cataract surgery. PDL will provide LENSAR with up to $60 million of debt financing to be used to refinance its existing credit facility and fund the commercialization of its currently marketed LENSAR Laser System. An initial $40 million was provided at close of the transaction, with the remaining $20 million to be funded upon the attainment of a specified sales milestone.


Page 1

PDL BioPharma, Inc.
Q3-2013
November 6, 2013



Update on Litigation with Genentech/Roche
PDL and Genentech/Roche have mutually agreed to stay the arbitration proceeding and to delay the time for responses in the Nevada litigation to allow time for discussions to determine if a settlement of certain issues is possible.  The parties may not reach agreement regarding settlement terms and PDL expects that it will renew its litigation efforts if settlement is unsuccessful.  PDL will have no further comment on this matter.

Term-loan of $75 Million
On October 28, 2013, PDL entered into a credit agreement with Royal Bank of Canada and Wells Fargo Bank. The Credit Agreement consists of a term loan of $75,000,000, with a term of one year.  PDL took advantage of an opportunity to borrow money at a very low cost of capital. The interest rates per annum applicable to amounts outstanding under the term loan are, at the Company’s option, either (a) the base rate (as defined in the Credit Agreement) plus 1.00%, or (b) the Eurodollar rate (as defined in the Credit Agreement) plus 2.00% per annum. Interest payments under the Credit Agreement are due on the interest payment dates specified in the Credit Agreement.

Updates on Approved Royalty Bearing Products

Avastin® (bevacizumab):
On October 17, 2013, Genentech/Roche reported that YTD worldwide sales increased by 13%.
There was significant increase in sales in US in colorectal cancer due to label expansion through multiple lines of therapy.
Strong sales in EU were driven by ovarian and colorectal cancers with the latter due to the label expansion through multiple lines of therapy.
Steady growth in Japan in colorectal cancer, breast cancer and non-small cell lung cancer.
On July 25, 2013, Genentech/Roche stated that it intends to file for approval for treatment of cervical cancer in US and EU in 2014.
On December 12, 2012 and January 24, 2013, Genentech/Roche announced EU and US approval, respectively for second line metastatic colorectal cancer.
Herceptin® (trastuzumab):
On October 17, 2013, Genentech/Roche reported that YTD worldwide sales increased by 6%.
On September 2, 2013, Genentech/Roche said European Commission approved a subcutaneous formulation of Herceptin to treat HER2-positive breast cancer.
Subcutaneous administration takes 2-5 minutes instead of 30-90 minutes with the approved IV administration.
Lucentis® (ranibizumab):
On October 17, 2013, Genentech/Roche reported that YTD US sales increased by 13%.
Less frequent than monthly dosing regimen is stabilizing market share in AMD.
Increasing share in RVO and DME markets.
On October 22, 2013, Novartis reported that 32Q13 ex-US sales were $581 million, down 1% from 3Q12.
Tysabri® (natalizumab):
On October 28, 2013, Biogen Idec reported that global sales in 3Q13 were $403 million, flat from a year ago.
Xolair® (omalizumab):
On October 17, 2013, Genentech/Roche reported that YTD US sales increased by 12%.
On October 22, 2013, Novartis reported that 3Q13 ex-US sales were $151 million, up 13% from 3Q12.
On June 26, 2013, Novartis announced that the second Phase 3 trial in 335 patients ages 12-75 with moderate to severe refractory chronic idiopathic urticaria (CIU) treated with 300 mg subcutaneous Xolair given every 4 weeks for 24 weeks as an add-on to antihistamine therapy met the primary efficacy endpoint with a similar incidence and severity of adverse events between treated and placebo patients.
In February 2013, Novartis reported data from the first Phase 3 in 323 patients ages 12-75 with moderate to severe refractory CIU showing that 150 and 300 mg doses of Xolair as an add-on to antihistamine therapy each met the primary efficacy endpoint.
On July 17, 2013, Novartis disclosed that it had filed for EU approval for CIU.

Page 2

PDL BioPharma, Inc.
Q3-2013
November 6, 2013



On October 10, 2013, Genentech/Roche announced that the FDA had accepted for filing the US approval application for CIU with a PDUFA date in second quarter of 2014.
Actemra® (tocilizumab):
On October 17, 2013, Genentech/Roche reported that YTD worldwide sales increased by 33%.
Sales growth was driven by monotherapy use with US being the biggest contributor to growth.
On October 21, 2013, Genentech/Roche announced approval of the subcutaneous formulation.
On April 30, 2013, Genentech/Roche announced that FDA had approved its use for the treatment of a rare, debilitating condition in children known as polyarticular juvenile idiopathic arthritis.
Perjeta™ (pertuzumab):
On October 17, 2013, Genentech/Roche reported YTD sales of CHF 186 million.
Genentech/Roche announced EMA approval in March 2013.
On September 30, 2013, Genentech/Roche announced that FDA had granted accelerated approval for the neo-adjuvant indication.
Kadcyla™ (TDM-1 or ado-trastuzumab emtansine):
On October 17, 2013, Genentech/Roche reported YTD sales of CHF 156 million.
On February 22, 2013, Genentech/Roche announced that FDA approval for second line treatment of HER2+ metastatic breast cancer and first line treatment for patients who relapse within 6 months following adjuvant therapy.
On September 20, 2013, EU's Committee for Medicinal Products for Human Use recommended approval for the treatment of adults with HER2-positive, inoperable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.
Also on September 20, 2013, Japan approved it for the same indication.
On July 25, 2013, Genentech/Roche announced that a Phase 3 trial comparing Kadcyla to the physician's choice of treatment in patients with HER2-positive breast cancer who have already been treated with a HER2-targeted therapy, met its co-primary endpoint of progression free survival. The other endpoint is overall survival, but these data are not yet mature.
Gazyva™ (Obinutuzumab or GA101):
On November 1, 2013, Genentech/Roche announced that Gazyva™ (obinutuzumab), formerly known as GA101, became the first therapy approved through the FDA’s breakthrough therapy designation, indicated in combination with chlorambucil to treat previously untreated chronic lymphocytic leukemia (CLL). Genentech/Roche expect Gazyva to be on the market in the United States by mid-November.
On May 15, 2013, Genentech/Roche announced approval applications for the treatment of chronic lymphocytic leukemia (CLL) had been submitted to regulatory authorities including the European Medicines Association (EMA) and the FDA.
Also announced, FDA designated it as a breakthrough therapy for CLL.
Previously, Genentech/Roche announced that results from Stage 1 of a Phase 3 trial showed CLL patients treated with obinutuzumab + chlorambucil had a progression free survival (PFS) of 23 months compared to 10.9 months for patients treated with chlorambucil only.
On July 2, 2013, Genentech/Roche announced FDA accepted their approval application and it had been granted priority review by FDA with a PDUFA date of December 20, 2013.
On July 23, 2013, Genentech/Roche announced that results from planned interim analysis of Stage 2 of same Phase 3 trial showed CLL patients treated with obinutuzumab + chlorambucil lived significantly longer without disease worsening (PFS) than patients receiving Rituxan + chlorambucil.
While the differences in PFS will not be disclosed until ASH in early December 2013, Genentech/Roche stated that the endpoint was achieved sooner than the target date of 2014 because of the magnitude of the difference between the two arms in Stage 2.

Page 3

PDL BioPharma, Inc.
Q3-2013
November 6, 2013





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. 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 4

PDL BioPharma, Inc.
Q3-2013
November 6, 2013



Royalty Revenue by Product ($ in 000's) *
Avastin
Q1
Q2
Q3
Q4
Total
2013
33,234

46,720

32,224


112,177

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
2013
30,287

47,353

30,961


108,602

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
2013
12,032

30,066

13,536


55,633

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
2013
5,930

10,025

7,334


23,288

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
2013
340

1,414

748


2,502

2012


58

250

308

2011





2010





2009





2008





2007





2006





Kadcyla
Q1
Q2
Q3
Q4
Total
2013

551

830


1,381

2012





2011





2010





2009





2008





2007





2006





Tysabri
Q1
Q2
Q3
Q4
Total
2013
12,965

13,616

11,622


38,203

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
2013
2,631

2,816

2,939


8,386

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





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


Page 5

PDL BioPharma, Inc.
Q3-2013
November 6, 2013



Reported Net Sales Revenue by Product ($ in 000's) *
Avastin
Q1
Q2
Q3
Q4
Total
2013
1,653,108

1,694,678

1,746,135


5,093,921

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
2013
1,681,574

1,744,145

1,681,860


5,107,579

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
2013
1,203,179

1,171,423

1,200,791


3,575,394

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
2013
341,309

365,778

391,900


1,098,987

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
2013
34,008

55,076

66,353


155,437

2012


5,080

25,000

30,079

2011





2010





2009





2008





2007





2006





Kadcyla
Q1
Q2
Q3
Q4
Total
2013

21,459

73,626


95,085

2012





2011





2010





2009





2008





2007





2006





Tysabri
Q1
Q2
Q3
Q4
Total
2013
434,677

451,358

387,407


1,273,442

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
2013
87,703

91,374

97,961


277,038

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

2006





* 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

PDL BioPharma, Inc.
Q3-2013
November 6, 2013




Manufacturing Location & Sales - Genentech / Roche & Novartis ($ in 000's) *
 
 
 
 
 
 
 
 
 
Avastin Sales
2012 - Q2
2012 - Q3
2012 - Q4
2013 - Q1
2013 - Q2
2013 - Q3
US Made & Sold
724,483

679,914

710,501

664,109

750,491

716,337

US Made & ex-US Sold
532,979

428,976

281,905

161,369

165,651

360,177

ex-US Made & Sold
316,265

442,437

670,572

827,629

778,536

669,621

Total
1,573,727

1,551,327

1,662,977

1,653,108

1,694,678

1,746,135

US Made & Sold
46
%
44
%
43
%
40
%
44
%
41
%
US Made & ex-US Sold
34
%
28
%
17
%
10
%
10
%
21
%
ex-US Made & Sold
20
%
29
%
40
%
50
%
46
%
38
%
 
 
 
 
 
 
 
Herceptin Sales
2012 - Q2
2012 - Q3
2012 - Q4
2013 - Q1
2013 - Q2
2013 - Q3
US Made & Sold
497,109

503,612

515,790

514,113

583,677

518,790

US Made & ex-US Sold
466,477

545,625

552,127

486,400

563,243

522,159

ex-US Made & Sold
661,727

614,459

582,578

681,060

597,225

640,911

Total
1,625,313

1,663,695

1,650,495

1,681,574

1,744,145

1,681,860

US Made & Sold
31
%
30
%
31
%
31
%
33
%
31
%
US Made & ex-US Sold
29
%
33
%
33
%
29
%
32
%
31
%
ex-US Made & Sold
41
%
37
%
35
%
41
%
34
%
38
%
 
 
 
 
 
 
 
Lucentis Sales
2012 - Q2
2012 - Q3
2012 - Q4
2013 - Q1
2013 - Q2
2013 - Q3
US Made & Sold
412,131

385,746

381,592

392,207

419,030

449,834

US Made & ex-US Sold
674,411

711,795

728,103

810,972

752,393

750,958

ex-US Made & Sold






Total
1,086,543

1,097,541

1,109,695

1,203,179

1,171,423

1,200,791

US Made & Sold
38
%
35
%
34
%
33
%
36
%
37
%
US Made & ex-US Sold
62
%
65
%
66
%
67
%
64
%
63
%
ex-US Made & Sold
%
%
%
%
%
%
 
 
 
 
 
 
 
Xolair Sales
2012 - Q2
2012 - Q3
2012 - Q4
2013 - Q1
2013 - Q2
2013 - Q3
US Made & Sold
193,600

211,702

210,892

207,976

218,860

236,180

US Made & ex-US Sold






ex-US Made & Sold
121,039

136,094

129,540

133,333

146,918

155,720

Total
314,638

347,796

340,431

341,309

365,778

391,900

US Made & Sold
62
%
61
%
62
%
61
%
60
%
60
%
US Made & ex-US Sold
%
%
%
%
%
%
ex-US Made & Sold
38
%
39
%
38
%
39
%
40
%
40
%
 
 
 
 
 
 
 
Perjeta Sales
2012 - Q2
2012 - Q3
2012 - Q4
2013 - Q1
2013 - Q2
2013 - Q3
US Made & Sold

5,080

24,571

32,377

48,979

49,111

US Made & ex-US Sold


428

1,632

6,096

17,242

ex-US Made & Sold






Total

5,080

25,000

34,008

55,076

66,353

US Made & Sold
%
100
%
98
%
95
%
89
%
74
%
US Made & ex-US Sold
%
%
2
%
5
%
11
%
26
%
ex-US Made & Sold
%
%
%
%
%
%
 
 
 
 
 
 
 
Kadcyla Sales
2012 - Q2
2012 - Q3
2012 - Q4
2013 - Q1
2013 - Q2
2013 - Q3
US Made & Sold




21,459

72,887

US Made & ex-US Sold





739

ex-US Made & Sold






Total




21,459

73,626

US Made & Sold
%
%
%
%
100
%
99
%
US Made & ex-US Sold
%
%
%
%
%
1
%
ex-US Made & Sold
%
%
%
%
%
%
 
 
 
 
 
 
 
Total Sales
2012 - Q2
2012 - Q3
2012 - Q4
2013 - Q1
2013 - Q2
2013 - Q3
US Made & Sold
1,827,323

1,786,053

1,843,345

1,810,783

2,042,496

2,043,139

US Made & ex-US Sold
1,673,867

1,686,395

1,562,564

1,460,373

1,487,383

1,651,276

ex-US Made & Sold
1,099,031

1,192,990

1,382,690

1,642,023

1,522,679

1,466,252

Total
4,600,221

4,665,438

4,788,598

4,913,178

5,052,559

5,160,667

US Made & Sold
40
%
38
%
38
%
37
%
40
%
40
%
US Made & ex-US Sold
36
%
36
%
33
%
30
%
29
%
32
%
ex-US Made & Sold
24
%
26
%
29
%
33
%
30
%
28
%
* 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
 
 
 
 


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