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8-K - FORM 8-K - PDL BIOPHARMA, INC.pdli20130808_8k.htm
EX-99 - EXHIBIT 99.2 - PDL BIOPHARMA, INC.ex99-2.htm
EX-99 - EXHIBIT 99.1 - PDL BIOPHARMA, INC.ex99-1.htm

Exhibit 99.3

 

PDL BioPharma, Inc.

Q2-2013

August 8, 2013

 

 

Following are some of the key points regarding PDL’s second quarter 2013 financial and business results.

 

Net Income

 

Net income for the second quarter of 2013 was $93.7 million, or $0.62 per diluted share, as compared with net income of $73.5 million, or $0.52 per diluted share, in the same quarter of 2012. The increase in net income in the second quarter is primarily due to the 14 percent increase in royalty revenues and the release of a tax liability of $5.7 million, which reduced the effective tax rate for the quarter.

 

2013 Dividends

On June 12, 2013, PDL paid its second quarterly dividend in 2013 to stockholders of record, totaling $21 million and using earnings generated in the second quarter of 2013. The Board of Directors previously declared two remaining dividends for 2013, each of $0.15 per share of common stock, payable on September 12 and December 12 of 2013 to all stockholders who own shares of PDL on September 5 and December 5 of 2013, the record dates for each of the dividend payments, respectively.

 

 

Updates on Approved Royalty Bearing Products

 

Avastin® (bevacizumab):

On July 25, 2013, Genentech/Roche reported that 1H13 worldwide sales increased by 12%.

 

 

o

There was significant increase in US sales in colorectal cancer due to label expansion through multiple lines of therapy.

 

 

o

Strong sales in EU were driven by ovarian and colorectal cancers, with the latter due to the label expansion through multiple lines of therapy.

 

 

o

In Japan, sales increase was driven by steady growth in non-small cell lung cancer.

 

Also 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 July 25, 2013, Genentech/Roche reported that 1H13 worldwide sales increased by 5%.

 

On June 28, 2013, Genentech/Roche said EMA’s CHMP issued a positive opinion recommending approval of a subcutaneous formulation of Herceptin to treat HER2-positive breast cancer.

 

 

o

Subcutaneous administration takes 2-5 minutes instead of 30-90 minutes with the approved IV administration.

 

Lucentis® (ranibizumab):

On July 25, 2013, Genentech/Roche reported that 1H13 US sales increased by 9%.

 

 

o

Less frequent than monthly dosing regimen is stabilizing market share in AMD.

 

 

o

RVO market share is stable and DME increased market share contributing to majority of Lucentis growth.

 

On July 17, 2013, Novartis reported that 2Q13 ex-US sales decreased by 3%.

 

 

o

Double digit volume growth offset by one-time price reductions required to secure reimbursement for new indications.

 

 

o

Eylea launched in key EU countries.

 

On July 5, 2013, Novartis announced that EU had expanded the label to include treatment for visual impairment due to choroidal neovascularization.

 

 

o

Lucentis is first therapy to be approved for this indication in EU.

 

Xolair® (omalizumab)

On July 25, 2013, Genentech/Roche reported that 1H13 US sales increased by 11%.

 

On July 17, 2013, Novartis reported that 2Q13 ex-US sales increased by 20%.

 

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.

 

 

o

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.

 

 

o

Genentech/Roche is expected to file for approval of this indication in 2H13.

 

 
Page 1

 

 

PDL BioPharma, Inc.

Q2-2013

August 8, 2013

 

Actemra® (tocilizumab):

On July 25, 2013, Genentech/Roche reported that 1H13 worldwide sales increased by 33%.

 

o

Sales growth was driven by monotherapy use with US being the biggest contributor to growth.

 

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 July 25, 2013, Genentech/Roche reported 1H13 sales of CHF 108 million.

Genentech/Roche announced EMA approval in March 2013.

On July 1, 2013, Genentech/Roche announced that it had been granted priority review by FDA for use in neo-adjuvant setting for HER2+ breast cancer with PDUFA date of October 31, 2013.

 

Kadcyla™ (TDM-1 or ado-trastuzumab emtansine):

On July 25, 2013, Genentech/Roche reported 1H13 sales of CHF 83 million.

[Not Q2 but may be relevant to understand first bullet] 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.

Also 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.

 

 

Updates on Select Development Stage Potential Royalty Bearing Products

 

Obinutuzumab:

On May 15, 2013, Genentech/Roche announced Phase 3 data from the CLL11 study to be presented at ASCO for the treatment of chronic lymphocytic leukemia (CLL).

 

o

Announced marketing applications had been submitted to regulatory authorities including the European Medicines Association (EMA) and the FDA.

 

o

Also announced, FDA designated it as a breakthrough therapy for CLL.

 

o

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 that FDA accepted their Biologics License Application (BLA) 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.

 

o

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.

 

Solanezumab:

On July 12, 2013, Lilly announced details regarding its new Phase 3 trial.

 

o

2,100 patients with mild Alzheimer’s Disease with amyloid pathology confirmed by either PET or cerebrospinal fluid instead of 1,322 mild Alzheimer’s Disease patients in previous Phase 3s.

 

o

Co-primary endpoints of ADAS-Cog14 (cognition) and ADCS-iADL (function) instead of ADAS-Cog11 and ADCS-ADL used in previous Phase 3s.

 

o

22 months for patient enrollment beginning in September 2013 plus 18 month for patient follow up equals 40 months, or late 2016, to data.

If solanezumab were to receive marketing authorization, PDL would receive a patent royalty of 3% through the expiration of Queen et al. patents in addition to a 12.5 year know-how royalty of 2% from date of first sale.

 

 
Page 2

 

  

PDL BioPharma, Inc.

Q2-2013

August 8, 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 3

 

 PDL BioPharma, Inc.

Q2-2013

August 8, 2013 

Royalty Revenue by Product ($ in 000's) *

 

Avastin

Q1

Q2

Q3

Q4

Total

2013

    33,234

    46,720

            -

            -

    79,953

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

            -

            -

    77,640

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

2013

    12,032

    30,066

            -

            -

    42,097

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

            -

            -

    15,955

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

            -

            -

     1,754

2012

            -

            -

          58

        250

        308

2011

            -

            -

            -

            -

            -

2010

            -

            -

            -

            -

            -

2009

            -

            -

            -

            -

            -

2008

            -

            -

            -

            -

            -

2007

            -

            -

            -

            -

            -

2006

            -

            -

            -

            -

            -

           

Kadcyla

Q1

Q2

Q3

Q4

Total

2013

            -

        551

            -

            -

        551

2012

            -

            -

            -

            -

            -

2011

            -

            -

            -

            -

            -

2010

            -

            -

            -

            -

            -

2009

            -

            -

            -

            -

            -

2008

            -

            -

            -

            -

            -

2007

            -

            -

            -

            -

            -

2006

            -

            -

            -

            -

            -

           

Tysabri

Q1

Q2

Q3

Q4

Total

2013

    12,965

    13,616

            -

            -

    26,581

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

            -

            -

     5,447

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 4

 

 

PDL BioPharma, Inc.

Q2-2013

August 8, 2013

 

Reported Net Sales Revenue by Product ($ in 000's) *

 

Avastin

Q1

Q2

Q3

Q4

Total

2013

1,653,108

1,694,678

               -

               -

3,347,786

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

               -

               -

3,425,718

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

               -

               -

2,374,602

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

               -

               -

     707,088

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

               -

               -

      89,084

2012

               -

               -

        5,080

      25,000

      30,079

2011

               -

               -

               -

               -

               -

2010

               -

               -

               -

               -

               -

2009

               -

               -

               -

               -

               -

2008

               -

               -

               -

               -

               -

2007

               -

               -

               -

               -

               -

2006

               -

               -

               -

               -

               -

           

Kadcyla

Q1

Q2

Q3

Q4

Total

2013

               -

      21,459

               -

               -

      21,459

2012

               -

               -

               -

               -

               -

2011

               -

               -

               -

               -

               -

2010

               -

               -

               -

               -

               -

2009

               -

               -

               -

               -

               -

2008

               -

               -

               -

               -

               -

2007

               -

               -

               -

               -

               -

2006

               -

               -

               -

               -

               -

           

Tysabri

Q1

Q2

Q3

Q4

Total

2013

     434,677

     451,358

               -

               -

     886,035

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

               -

               -

     179,077

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 licensees

   Totals may not sum due to rounding

 

 
Page 5

 

 

PDL BioPharma, Inc.

Q2-2013

August 8, 2013

 

Manufacturing Location & Sales - Genentech / Roche & Novartis ($ in 000's) *

Avastin Sales

2012 - Q1

2012 - Q2

2012 - Q3

2012 - Q4

2013 - Q1

2013 - Q2

US Made & Sold

        652,824

        724,483

        679,914

        710,501

        664,109

       750,491

US Made & ex-US Sold

        448,037

        532,979

        428,976

        281,905

        161,369

       165,651

ex-US Made & Sold

        401,896

        316,265

        442,437

        670,572

        827,629

       778,536

Total

     1,502,757

     1,573,727

     1,551,327

     1,662,977

     1,653,108

    1,694,678

US Made & Sold

43%

46%

44%

43%

40%

44%

US Made & ex-US Sold

30%

34%

28%

17%

10%

10%

ex-US Made & Sold

27%

20%

29%

40%

50%

46%

             

Herceptin Sales

2012 - Q1

2012 - Q2

2012 - Q3

2012 - Q4

2013 - Q1

2013 - Q2

US Made & Sold

        456,920

        497,109

        503,612

        515,790

        514,113

       583,677

US Made & ex-US Sold

        523,353

        466,477

        545,625

        552,127

        486,400

       563,243

ex-US Made & Sold

        534,982

        661,727

        614,459

        582,578

        681,060

       597,225

Total

     1,515,255

     1,625,313

     1,663,695

     1,650,495

     1,681,574

    1,744,145

US Made & Sold

30%

31%

30%

31%

31%

33%

US Made & ex-US Sold

35%

29%

33%

33%

29%

32%

ex-US Made & Sold

35%

41%

37%

35%

41%

34%

             

Lucentis Sales

2012 - Q1

2012 - Q2

2012 - Q3

2012 - Q4

2013 - Q1

2013 - Q2

US Made & Sold

        433,428

        412,131

        385,746

        381,592

        392,207

       419,030

US Made & ex-US Sold

        645,665

        674,411

        711,795

        728,103

        810,972

       752,393

ex-US Made & Sold

                   -

                   -

                   -

                   -

                   -

                 -

Total

     1,079,092

     1,086,543

     1,097,541

     1,109,695

     1,203,179

    1,171,423

US Made & Sold

40%

38%

35%

34%

33%

36%

US Made & ex-US Sold

60%

62%

65%

66%

67%

64%

ex-US Made & Sold

0%

0%

0%

0%

0%

0%

             

Xolair Sales

2012 - Q1

2012 - Q2

2012 - Q3

2012 - Q4

2013 - Q1

2013 - Q2

US Made & Sold

        185,505

        193,600

        211,702

        210,892

        207,976

       218,860

US Made & ex-US Sold

                   -

                   -

                   -

                   -

                   -

                 -

ex-US Made & Sold

        124,729

        121,039

        136,094

        129,540

        133,333

       146,918

Total

        310,234

        314,638

        347,796

        340,431

        341,309

       365,778

US Made & Sold

60%

62%

61%

62%

61%

60%

US Made & ex-US Sold

0%

0%

0%

0%

0%

0%

ex-US Made & Sold

40%

38%

39%

38%

39%

40%

             

Perjeta Sales

2012 - Q1

2012 - Q2

2012 - Q3

2012 - Q4

2013 - Q1

2013 - Q2

US Made & Sold

                   -

                   -

            5,080

          24,571

          32,377

        48,979

US Made & ex-US Sold

                   -

                   -

                   -

              428

            1,632

          6,096

ex-US Made & Sold

                   -

                   -

                   -

                   -

                   -

                 -

Total

                   -

                   -

            5,080

          25,000

          34,008

        55,076

US Made & Sold

0%

0%

100%

98%

95%

89%

US Made & ex-US Sold

0%

0%

0%

2%

5%

11%

ex-US Made & Sold

0%

0%

0%

0%

0%

0%

             

Kadcyla Sales

2012 - Q1

2012 - Q2

2012 - Q3

2012 - Q4

2013 - Q1

2013 - Q2

US Made & Sold

                   -

                   -

                   -

                   -

                   -

        21,459

US Made & ex-US Sold

                   -

                   -

                   -

                   -

                   -

                 -

ex-US Made & Sold

                   -

                   -

                   -

                   -

                   -

                 -

Total

                   -

                   -

                   -

                   -

                   -

        21,459

US Made & Sold

0%

0%

0%

0%

0%

100%

US Made & ex-US Sold

0%

0%

0%

0%

0%

0%

ex-US Made & Sold

0%

0%

0%

0%

0%

0%

             

Total Sales

2012 - Q1

2012 - Q2

2012 - Q3

2012 - Q4

2013 - Q1

2013 - Q2

US Made & Sold

     1,728,678

     1,827,323

     1,786,053

     1,843,345

     1,810,783

    2,042,496

US Made & ex-US Sold

     1,617,054

     1,673,867

     1,686,395

     1,562,564

     1,460,373

    1,487,383

ex-US Made & Sold

     1,061,607

     1,099,031

     1,192,990

     1,382,690

     1,642,023

    1,522,679

Total

     4,407,339

     4,600,221

     4,665,438

     4,788,598

     4,913,178

    5,052,559

US Made & Sold

39%

40%

38%

38%

37%

40%

US Made & ex-US Sold

37%

36%

36%

33%

30%

29%

ex-US Made & Sold

24%

24%

26%

29%

33%

30%

             

* As reported to PDL by its licensees

   Totals may not sum due to rounding

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