Protein Design Labs Announces Third Quarter 2004 Financial Results Raises Full-Year 2004 Revenue Guidance to $93-$95 Million From $88-$91 Million



    FREMONT, Calif., Nov. 1 /PRNewswire-FirstCall/ -- Protein Design Labs,
 Inc. (PDL) (Nasdaq:   PDLI) today reported a net loss of $13.6 million, or
 $0.14 per basic and diluted share, for the three months ended September 30,
 2004, compared with a net loss of $18.9 million, or $0.20 per basic and
 diluted share, for the three months ended September 30, 2003.  Excluding
 certain non-cash charges, the non-GAAP net loss in the third quarter of 2004
 would have been $12.6 million, or $0.13 per basic and diluted share, compared
 with a non-GAAP net loss of $18.6 million, or $0.20 per basic and diluted
 share in the 2003 third quarter.
     As of September 30, 2004, PDL had cash, cash equivalents, marketable
 securities and restricted investments totaling approximately $425.8 million,
 compared with $505.0 million at December 31, 2003.  The September 30, 2004
 balances reflected approximately $80.7 million in capital expenditures made
 during the first nine months of 2004, primarily related to budgeted, ongoing
 construction of PDL's manufacturing plant at Brooklyn Park, Minnesota.
     Total revenues in the 2004 third quarter were $19.8 million, an increase
 of 112% over total revenues of $9.3 million in the same three months of 2003.
 The increase included a 96% increase in royalties, which totaled $17.1 million
 in the 2004 third quarter, compared with $8.8 million in the same three months
 of 2003.  License and other revenues of $2.7 million increased from
 $0.6 million in the prior-year period as a result of entering into additional
 collaboration agreements in the third quarter of 2004, including approximately
 $1.2 million related to one month of revenue under the September 2004
 agreement with Roche for the further development and commercialization of
 Zenapax(R) (daclizumab) in asthma and related respiratory diseases, and
 $1.0 million in revenue related to a patent rights agreement with Morphotek,
 Inc.
     Royalty revenues in the 2004 third quarter were based on sales of seven
 marketed antibody products licensed under PDL's antibody humanization patents.
 The licensed products are Synagis(R) from MedImmune, Inc.; Herceptin(R),
 Xolair(R), RAPTIVA(TM) and Avastin(TM) from Genentech, Inc.; Mylotarg(R) from
 Wyeth; and Zenapax from Roche.  Higher royalty revenues in the third quarter
 of 2004 compared to the same period in 2003 primarily were due to significant
 sales of Avastin and continued sales growth of Herceptin.  Royalty revenues in
 the 2003 third quarter did not include royalties on Avastin, Xolair and
 RAPTIVA.
     Total costs and expenses were $35.0 million in the 2004 third quarter,
 compared with $28.8 million in the comparable three months of 2003.  Excluding
 certain non-cash charges, which consist of the amortization of intangible
 assets associated with the Eos acquisition and the re-acquisition of rights to
 manufacture and market Zenapax in the fourth quarter of 2003, restructuring
 charges related to the closure of PDL's New Jersey facility in the second
 quarter of 2004, as well as stock-based compensation charges, non-GAAP total
 costs and expenses in the 2004 third quarter would have been $34.0 million
 compared to $28.5 million for the comparable period in 2003.
     Research and development expenses increased 25% to $27.3 million in the
 2004 third quarter, compared with $21.8 million in the 2003 third quarter.
 The increase in research and development expenses reflected additional
 headcount and associated costs required to pursue research and clinical
 development programs; contract manufacturing and direct scale-up and
 manufacturing expense; increased research activities; and facility and
 equipment-related costs.  General and administrative expenses increased to
 $7.7 million in the 2004 third quarter from $7.0 million in the 2003 third
 quarter.
     Total revenues during the first nine months of 2004 were $73.2 million,
 compared with $53.1 million in the first nine months of 2003.  Royalties in
 the first nine months this year were $63.9 million, or 46% higher than the
 $43.8 million of royalties reported in the first nine months of 2003.
 Research and development expenses were $92.4 million in the first nine months
 of 2004, compared with $58.3 million in the comparable nine months of 2003.
 General and administrative expenses were $23.2 million and $19.5 million in
 the first nine months of 2004 and 2003, respectively.  PDL reported a net loss
 of $38.7 million, or $0.41 per basic and diluted share, for the first nine
 months of 2004, compared with a net loss of $57.0 million, or $0.62 per basic
 and diluted share, in the first nine months of 2003, which included an
 acquired in-process research and development charge of $37.8 million.
 Excluding certain non-cash charges, the non-GAAP net loss in the first nine
 months of 2004 would have been $35.7 million, or $0.38 per basic and diluted
 share, compared with a non-GAAP net loss of $18.5 million, or $0.20 per basic
 and diluted share in the comparable period of 2003.
 
     Third Quarter 2004 Clinical Development Highlights
 
     Nuvion(R) Antibody Product (visilizumab, humanized anti-CD3).  Interim
 results from the Phase I dose-ranging portion of a Phase I / II clinical trial
 of visilizumab in patients with severe ulcerative colitis who have not
 responded to treatment with intravenous (I.V.) steroids were reported in late
 September 2004.  The ongoing trial is designed to explore four dose levels
 from 5 micrograms/kg to 12.5 micrograms/kg given I.V. on days 1 and 2 as a
 bolus injection.  Following the Phase I portion of the study, PDL plans to
 treat up to an additional 20 patients in the Phase II portion.
     The interim Phase I data assessed a total of 50 patients for safety across
 the 5, 7.5, 10 and 12.5 micrograms/kg doses.  In the 5, 7.5 and 10
 micrograms/kg doses, 30 patients were also evaluable for efficacy at study day
 30.
     PDL reported that visilizumab was generally well tolerated and that at the
 5, 7.5 and 10 micrograms/kg doses, 63% of the patients evaluated at day 30 had
 improved mucosal scores to normal, or only mildly abnormal, findings.
     In a completed, 32-patient Phase I study of two dose cohorts that was
 reported in May 2004, a strong signal of activity was observed in the first
 dose cohort given at 15 micrograms/kg on days 1 and 2, in which all eight
 patients achieved remission.  A continued strong signal of activity
 subsequently was observed in the second dose cohort given at 10 micrograms/kg
 administered I.V. on days 1 and 2.  At the 10 microgramsg/kg dose level, 19 of
 24 patients responded to treatment and of these, 13 achieved remission.
     PDL additionally announced in late September that the FDA had granted Fast
 Track status to the investigation of visilizumab in patients with intravenous
 steroid-refractory ulcerative colitis.  Designation as a Fast Track product
 indicates that the FDA will facilitate the development and expedite the review
 of a new drug that is intended to treat a serious or life-threatening
 condition, and that demonstrates the potential to address an unmet medical
 need.
     PDL currently plans to conduct an end-of-Phase I meeting with the FDA in
 the first quarter of 2005.
 
     Daclizumab (Zenapax(R), anti-CD25).  PDL and Roche in September announced
 a worldwide agreement to co-develop and commercialize Zenapax(R) (daclizumab)
 for asthma and related respiratory diseases, based on recent positive Phase II
 data in patients with moderate to severe asthma.  Under terms of the
 agreement, PDL has received a $17.5 million upfront payment and may receive up
 to $187.5 million in milestones for successful further development of
 daclizumab.  Roche and PDL will globally co-develop daclizumab in asthma,
 share development expenses and co-promote the product in the United States.
 Outside the United States, PDL will receive royalties on net sales of the
 product in asthma and related respiratory diseases.
     In March 2004, PDL reported positive results from the initial clinical
 study of daclizumab in patients with chronic, persistent asthma whose disease
 is not well controlled with high doses of inhaled corticosteroids.  There were
 statistically significant treatment differences (p=0.05) observed for the
 primary endpoint,  percent change in FEV1 from baseline to 12 weeks (day 84).
 Secondary clinical endpoints also supported these findings.  Treatment with
 daclizumab was generally well tolerated.   PDL currently expects that the next
 trial of daclizumab in asthma will be a small Phase I clinical trial intended
 to gather additional experience with the PDL-manufactured subcutaneous
 formulation of daclizumab in healthy volunteers, and should begin in the
 fourth quarter of this year.  The company expects that a subsequent Phase IIb
 clinical trial in moderate-to-severe persistent asthma should begin by the
 third quarter of 2005.
     Preparatory work for a PDL study of daclizumab in multiple sclerosis (MS)
 continues, and the company currently plans to initiate a Phase II study in MS
 in the first quarter of 2005.
 
     M200 (anti-alpha5beta1 integrin antibody).  PDL in September presented
 interim clinical data from a Phase I dose-escalation study of M200 for the
 treatment of refractory solid tumors.  M200 is an anti-angiogenic antibody
 that targets the endothelium of tumor neovasculature.
     Sixteen men and women between the ages of 29 and 81 (mean 58 years) with
 various solid tumor types refractory to standard therapy have been enrolled in
 this study.  Tumor types included colorectal, melanoma, hepatic, pancreatic
 and non-small cell lung cancers.  Patients were enrolled into dose cohorts as
 follows:  one patient at 0.5 mg/kg, 2 patients at 1 mg/kg, 3 patients at
 2.5 mg/kg, 3 patients at 5.0 mg/kg and 6 patients at 10 mg/kg.  Each patient
 received 5 doses of M200 on study days 1, 15, 22, 29 and 36.  The study data
 showed that adverse events were generally mild to moderate in intensity and
 included fatigue, nausea, constipation, headache and anorexia.  There were no
 severe or serious adverse events that were dose limiting or considered by
 investigators to be related to M200.
     In addition, 10 of 15 evaluable patients had stable disease as their best
 response, and five of six patients treated at the highest dose level,
 10 mg/kg, achieved stable disease.  Four patients with stable disease after
 5 doses of M200 in the Phase I study continued treatment with M200 in a Phase
 I extension study.  Three of these patients maintained stable disease for
 greater than 16 weeks over the two studies.
     PDL plans to initiate over the next few quarters a series of open-label,
 Phase II trials in renal, melanoma, pancreatic and non-small cell lung cancers
 in both combination studies with chemotherapy as well as single-agent use.
 
     F200 (anti-alpha5beta1 integrin antibody fragment).  PDL in early October
 reported preclinical data which demonstrated that F200 can inhibit retinal
 neovascularization induced by multiple growth factors, such as VEGF and bFGF,
 and supports previous data which demonstrated that F200 can block
 neovascularization in an experimental CNV animal model.  PDL currently expects
 to enter F200 into clinical trials by year-end 2005 for the potential
 treatment of age-related macular degeneration (AMD).
 
     Outlook
     The following statements are based on expectations as of November 1, 2004.
 These statements are forward-looking, and actual results may differ
 materially.  Except as expressly set forth below, these statements do not
 include the potential impact of new collaborations, material licensing
 arrangements or other strategic transactions.
     As we previously indicated, the signing of our corporate collaboration
 involving Zenapax in asthma with Hoffmann-La Roche (Roche) in the quarter as
 well as the continued strong initial sales of Genentech's Avastin antibody
 product will result in a significant favorable increase in financial guidance
 for the year.  As we noted on our September 16, 2004 conference call
 describing in more detail the Roche collaboration, the upfront $17.5 million
 payment received from Roche in September will be amortized over a period of
 six years, and reimbursement of half of the research expenses related to the
 U.S. asthma development program and manufacturing is being recognized as
 revenue in the License and Other Income line of our Consolidated Statements of
 Operations, effective September 1, 2004.
     We are updating our financial guidance for 2004 compared to 2003 with
 expectations compared to December 31, 2003 non-GAAP performance as follows:
 (a) total revenues are expected to be in the range of $93 to $95 million, an
 increase of approximately 39-42% compared to total revenues in 2003; (b)
 interest income for the year to total approximately $10 million and interest
 expense of approximately $5 million; (c) total costs and expenses of
 approximately $149 to $154 million, an increase of approximately 35-40% in
 2004 compared with total costs and expenses in 2003; and (d) capital
 expenditures in the range of approximately $88 million to $93 million in 2004.
 Approximately $20 million of capital expenditures related to completion and
 validation of our Brooklyn Park facility are now anticipated to be delayed in
 2004 and are therefore expected to be incurred in 2005.  As a result, we
 expect a net loss in 2004 in the range of approximately $52.0 million to
 $57.0 million, or approximately $0.55 to $0.60 per basic and diluted share.
 We continue to expect total full-time employee headcount to be in the range of
 650-675 at year-end 2004.
     Finally, we anticipate having available cash, cash equivalents, marketable
 securities and restricted investments of approximately $400 million at the end
 of 2004.  The change from previous end-of-year cash guidance is attributable
 to the Roche transaction, to improved overall royalty revenues and to
 significant cash arising from the Employee Stock Purchase Plan and stock
 option exercises.
 
     PDL will webcast a conference call live at 4:30 p.m. Eastern time today to
 review its third quarter 2004 financial results.  A link to the conference
 call webcast will be available through the PDL website:  www.pdl.com.  Please
 connect to this website at least 15 minutes prior to the conference call to
 ensure adequate time for any software download that may be needed to hear the
 webcast.  The webcast will be archived at www.pdl.com starting at
 approximately 6:30 p.m. Eastern time on November 1.  A replay of the
 conference call will also be available by telephone from approximately
 6:30 p.m. Eastern time on November 1 through 6:30 p.m. Eastern time on
 November 4, 2004.  To access the replay, dial 800-633-8284 from inside the
 United States and 402-977-9140 from outside the United States and enter
 conference ID number 21212418.
 
     The foregoing contains forward-looking statements involving risks and
 uncertainties and PDL's actual results may differ materially from those,
 express or implied, in the forward-looking statements.  Factors that may cause
 differences between current expectations and actual results include, but are
 not limited to, the following:  Financial results for 2004 are unpredictable
 and may fluctuate from quarter to quarter.  PDL expenses, in principal part,
 depend on the total headcount of the organization and the timing of expenses.
 PDL revenues depend on the success and timing of sales of our licensees and
 partners, including in particular the continued successful launch of Avastin
 antibody product by Genentech, as well as the seasonality of sales of Synagis
 from MedImmune, Inc.  In addition, quarterly revenues may be impacted by our
 ability to maintain and increase our revenues from licensing, which revenues
 depend on third parties entering into new patent licensing arrangements,
 exercising rights under existing patent rights agreements, paying royalties
 under existing patent licenses and the timing of the recognition of revenues
 under any new and existing agreements.  Our revenues and expenses would also
 be affected by the continuation of our asthma collaboration with Roche, new
 collaborations, material patent licensing arrangements or other strategic
 transactions.
     Further, there can be no assurance that results from completed and ongoing
 clinical studies, described above, will be successful or completed or
 initiated on the anticipated schedules.  Other factors that may cause our
 actual results to differ materially from those, express or implied, in the
 forward-looking statements in this press release are discussed in our Annual
 Report on Form 10-K for the year ended December 31, 2003, in our quarterly
 report on Form 10-Q for the period ended June 30, 2004, and in other
 filings with the Securities and Exchange Commission.  PDL expressly disclaims
 any obligation or undertaking to release publicly any updates or revisions to
 any forward-looking statements contained herein to reflect any change in our
 expectations with regard thereto or any change in events, conditions or
 circumstances on which any such statements are based.
 
     Protein Design Labs is a leader in the development of humanized antibodies
 to prevent or treat various disease conditions.  PDL currently has antibodies
 under development for autoimmune and inflammatory conditions, asthma and
 cancer.  PDL holds fundamental patents for its antibody humanization
 technology.  Further information on PDL is available at www.pdl.com.
 
     NOTE:  Protein Design Labs, the PDL logo and Nuvion are registered U.S.
 trademarks of Protein Design Labs, Inc.  Zenapax is a registered trademark of
 Roche.  Synagis is a registered U.S. trademark of MedImmune, Inc.  Herceptin
 and RAPTIVA are registered U.S. trademarks and Avastin is a trademark of
 Genentech, Inc.  Xolair is a trademark of Novartis AG.  Mylotarg is a
 registered U.S. trademark of Wyeth.
 
 
                           PROTEIN DESIGN LABS, INC.
                     CONSOLIDATED STATEMENTS OF OPERATIONS
                                  (Unaudited)
 
     (In thousands, except per share data )
 
                                         Three months ended  Nine months ended
                                           September 30,        September 30,
                                           2004      2003      2004      2003
     Revenues:
       Royalties                         $17,131    $8,758   $63,872   $43,808
       License and other                   2,653       567     9,323     9,265
 
     Total revenues                       19,784     9,325    73,195    53,073
 
     Costs and expenses:
       Research and development           27,326    21,812    92,364    58,323
       General and administrative          7,664     6,963    23,182    19,465
       Acquired in-process research and
        development                           --        --        --    37,834
     Total costs and expenses             34,990    28,775   115,546   115,622
 
     Operating loss                      (15,206)  (19,450)  (42,351)  (62,549)
 
       Interest and other income, net      2,822     4,291     7,689    13,151
       Interest expense                   (1,193)   (3,705)   (3,929)   (7,346)
       Impairment loss on investment          --        --        --      (150)
 
      Loss before income taxes           (13,577)  (18,864)  (38,591)  (56,894)
        Provision for income taxes            12        11        68        60
 
     Net loss                           $(13,589) $(18,875) $(38,659) $(56,954)
 
     Net loss per basic and diluted
      share:                              $(0.14)   $(0.20)   $(0.41)   $(0.62)
 
     Shares used in computation of net
      loss per basic and diluted share:   95,196    93,665    94,771    92,049
 
 
                        CONSOLIDATED BALANCE SHEET DATA
                                  (Unaudited)
 
                                               September 30,      December 31,
                                                   2004               2003*
     (In thousands)                                       (unaudited)
 
     Cash, cash equivalents, marketable
      securities and restricted investments       $425,797           $504,993
     Total assets                                  727,780            742,030
     Total stockholders' equity                    423,717            448,331
 
     * Derived from the December 31, 2003 audited consolidated financial
       statements
 
 
                             PROTEIN DESIGN LABS, INC.
                  NON-GAAP CONSOLIDATED STATEMENTS OF OPERATIONS
                                    (Unaudited)
 
     We use non-GAAP amounts that exclude certain non-cash charges, including
 amounts related to the amortization of intangible assets and stock-based
 compensation.  Management believes that these non-GAAP measures enhance an
 investor's overall understanding of our financial performance and future
 prospects by reconciling more closely to the actual cash expenses of the
 Company in its operations.  Our management uses these non-GAAP financial
 measures in evaluating the Company's operating performance and for budgeting
 and planning purposes.
 
     (In thousands, except per share data )
                                            Three months ended September 30,
                                                         2004
                                                GAAP   Adjustment    Non-GAAP
     Revenues:
       Royalties                              $17,131                $17,131
       License and other                        2,653                  2,653
 
     Total revenues                            19,784                 19,784
 
     Costs and expenses:
       Research and development                27,326    (958)(1)     26,368
       General and administrative               7,664     (14)(1)      7,650
       Acquired in-process research and
        development                                --                     --
     Total costs and expenses                  34,990    (972)        34,018
     Operating loss                           (15,206)    972        (14,234)
 
       Interest and other income, net           2,822                  2,822
       Interest expense                        (1,193)                (1,193)
       Impairment loss on investment               --                     --
 
       Loss before income taxes               (13,577)    972        (12,605)
       Provision for income taxes                  12                     12
 
     Net loss                                $(13,589)   $972       $(12,617)
 
     Net loss per basic and diluted share:     $(0.14)                $(0.13)
 
     Shares used in computation of net
      loss per basic and diluted share:        95,196                 95,196
 
 
     (In thousands, except per share data )
                                              Three months ended September 30,
                                                         2003
                                                GAAP   Adjustment    Non-GAAP
     Revenues:
       Royalties                               $8,758                 $8,758
       License and other                          567                    567
 
     Total revenues                             9,325                  9,325
 
     Costs and expenses:
       Research and development                21,812    (217)(2)     21,595
       General and administrative               6,963     (14)(2)      6,949
       Acquired in-process research and
        development                                --                     --
     Total costs and expenses                  28,775    (231)        28,544
     Operating loss                           (19,450)    231        (19,219)
 
       Interest and other income, net           4,291                  4,291
       Interest expense                        (3,705)                (3,705)
       Impairment loss on investment               --                    --
 
       Loss before income taxes               (18,864)    231        (18,633)
       Provision for income taxes                  11                     11
 
     Net loss                                $(18,875)   $231       $(18,644)
 
     Net loss per basic and diluted share:     $(0.20)                $(0.20)
 
     Shares used in computation of net
      loss per basic and diluted share:        93,665                 93,665
 
     (1) To exclude (i) the ongoing, non-cash amortization of acquired net
         intangible assets, including workforce, related to the Eos
         acquisition, and core technology, related to the purchase of certain
         patent rights from Roche, (ii) the restructuring charges related to
         the closure of our New Jersey facility and (iii) stock-based
         compensation charges related to stock options issued to non-employees
         and modifications to certain employee stock options.
 
     (2) To exclude (i) the ongoing, non-cash amortization of acquired net
         intangible assets, including workforce, related to the Eos
         acquisition, and (ii) stock-based compensation charges related to
         stock options issued to non-employees.
 
 
                             PROTEIN DESIGN LABS, INC.
                   NON-GAAP CONSOLIDATED STATEMENTS OF OPERATIONS
                                    (Unaudited)
 
     We use non-GAAP amounts that exclude certain non-cash charges, including
 amounts related to the amortization of intangible assets and stock-based
 compensation.  Management believes that these non-GAAP measures enhance an
 investor's overall understanding of our financial performance and future
 prospects by reconciling more closely to the actual cash expenses of the
 Company in its operations.  Our management uses these non-GAAP financial
 measures in evaluating the Company's operating performance and for budgeting
 and planning purposes.
 
     (In thousands, except per share data )
                                               Nine months ended September 30,
                                                          2004
                                               GAAP    Adjustment     Non-GAAP
     Revenues:
       Royalties                              $63,872                  $63,872
       License and other                        9,323                    9,323
 
     Total revenues                            73,195                   73,195
 
     Costs and expenses:
       Research and development                92,364    (2,954)(1)     89,410
       General and administrative              23,182       (42)(1)     23,140
       Acquired in-process research and
        development                               --                        --
     Total costs and expenses                 115,546    (2,996)       112,550
     Operating loss                           (42,351)    2,996        (39,355)
 
       Interest and other income, net           7,689                    7,689
       Interest expense                        (3,929)                  (3,929)
       Impairment loss on investment               --                       --
 
       Income (loss) before income  taxes     (38,591)    2,996        (35,595)
       Provision for income taxes                  68                       68
 
     Net loss                                $(38,659)   $2,996       $(35,663)
 
     Net loss per basic and diluted share:     $(0.41)                  $(0.38)
 
     Shares used in computation of net
      loss per basic and diluted share:        94,771                   94,771
 
 
     (In thousands, except per share data )
                                              Nine months ended September 30,
                                                         2003
                                              GAAP    Adjustment    Non-GAAP
     Revenues:
       Royalties                             $43,808                 $43,808
       License and other                       9,265                   9,265
 
     Total revenues                           53,073                  53,073
 
     Costs and expenses:
       Research and development               58,323      (579)(2)    57,744
       General and administrative             19,465       (28)(2)    19,437
       Acquired in-process research and
        development                           37,834   (37,834)(3)        --
     Total costs and expenses                115,622   (38,441)       77,181
     Operating loss                          (62,549)   38,441       (24,108)
 
       Interest and other income, net         13,151                   8,861
       Interest expense                       (7,346)                 (7,346)
       Impairment loss on investment            (150)                   (150)
 
       Income (loss) before income  taxes    (56,894)   38,441       (18,453)
       Provision for income taxes                 60                      60
 
     Net loss                               $(56,954)  $38,441      $(18,513)
 
     Net loss per basic and diluted share:    $(0.62)                 $(0.20)
 
     Shares used in computation of net
      loss per basic and diluted share:       92,049                  92,049
 
     (1) To exclude (i) the ongoing, non-cash amortization of acquired net
         intangible assets, including workforce, related to the Eos
         acquisition, and core technology, related to the purchase of certain
         patent rights from Roche, (ii) the restructuring charges related to
         the closure of our New Jersey facility and (iii) stock-based
         compensation charges related to stock options issued to non-employees
         and modifications to certain employee stock options.
 
     (2) To exclude (i) the ongoing, non-cash amortization of acquired net
         intangible assets, including workforce, related to the Eos
         acquisition, and (ii) stock-based compensation charges related to
         stock options issued to non-employees.
 
     (3) To exclude the non-cash charge of acquired in-process research and
         development, related to the Eos acquisition.
 
 
 

SOURCE Protein Design Labs, Inc.
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