Delaware | 0-19311 | 33-0112644 | ||
(State or other jurisdiction | (Commission | (IRS Employer | ||
of incorporation) | file number) | Identification No.) |
14 Cambridge Center, Cambridge, Massachusetts (Address of principal executive offices) |
02142 (Zip Code) |
o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
99.1 | Registrants press release dated February 15, 2007. |
|
99.2 | Registrants presentation dated February 15, 2007. |
Biogen Idec Inc. |
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By: | /s/ Robert A. Licht | |||
Robert A. Licht | ||||
Vice President and Assistant Secretary | ||||
Exhibit | ||
Number | Description | |
99.1
|
Registrants press release dated February 15, 2007. | |
99.2
|
Registrants presentation dated February 15, 2007. |
| Total revenues in 2006 were $2.68 billion, an increase of 11% from $2.42 billion in 2005. The increase was driven primarily by RITUXANÒ (rituximab) revenues from the unconsolidated joint business arrangement, which were up 14% to $811 million and AVONEXÒ (interferon beta-1a) sales, which increased 11% to $1.71 billion. During 2006, Biogen Idec also successfully launched RITUXAN in rheumatoid arthritis (RA) and TYSABRIÒ (natalizumab) in multiple sclerosis (MS). |
| On a reported basis, calculated in accordance with accounting principles generally accepted in the U.S. (GAAP), full year 2006 diluted earnings per share (EPS) were $0.63, an increase of 34% over $0.47 in 2005. GAAP net income for 2006 was $218 million, an increase of 35% over 2005 GAAP net income of $161 million. |
| Non-GAAP diluted EPS for 2006 were $2.25, an increase of 43% over 2005. Non-GAAP net income for 2006 was $777 million, an increase of 43% over 2005 non-GAAP net income of $542 million. These non-GAAP results exclude purchase accounting and merger-related accounting impacts, stock option expense and the cumulative effect of an accounting change relating to the adoption of the stock option expensing rules, and other items. |
| Fourth quarter revenues were $708 million, an increase of 12% from $633 million in the prior year, driven primarily by AVONEX sales up 6% to $439 million and RITUXAN revenues from the unconsolidated joint business arrangement up 20% to $218 million. |
| Fourth quarter 2006 GAAP diluted EPS were $0.32, an increase of 100% from $0.16 in the fourth quarter of 2005. GAAP net income for the quarter was $109 million, an increase of 95% from $56 million in the prior year. |
| Fourth quarter 2006 non-GAAP diluted EPS were $0.53, an increase of 10% over non-GAAP diluted EPS of $0.48 in the fourth quarter 2005. Non-GAAP net income for the fourth quarter was $184 million, an increase of 11% over non-GAAP net income of $165 million in the fourth quarter of 2005. These non-GAAP results exclude purchase accounting and merger-related accounting impacts, stock option expense and the cumulative effect of an accounting change relating to the adoption of the stock option expensing rules, and other items. |
| Global in-market net sales of TYSABRI in the fourth quarter of 2006 were $30 million, comprised of $23 million in the U.S. and $7 million in Europe. Based on our collaboration structure with Elan, Biogen Idec recognized revenue of $18 million related to TYSABRI in the fourth quarter of 2006. |
| Pre-tax charges of $60 million for the amortization of intangibles relating to the 2003 Biogen and Idec merger and the acquisitions of Conforma and Fumapharm; |
| Pre-tax loss of $28 million on the settlement of a license agreement with Fumedica; |
| Pre-tax gain of $16 million on the sale of our Bio-1 research facility located in Cambridge, MA; |
| Pre-tax share-based payment expense under FAS 123R of $8 million (or $0.01 per share), primarily employee stock option expense; and |
| Tax benefit relating to the pre-tax items listed above. |
| $10.3 million related to product sold through Elan in the U.S.; and |
| $7.2 million related to product sold in Europe. |
| Total revenue growth of mid-teens percentage over 2006; |
| We expect the non-GAAP P&L to have a margin structure (as a percentage of revenues) similar to 2006, with the exception of Research and Development expense; |
| Research and Development expense of 27 29% of total revenues, assuming a slightly higher level of new business development than in 2006. This excludes any potential charges for acquired in-process research and development (IPR&D). |
| Non-GAAP diluted EPS will be in the range of $2.50 $2.65. This non-GAAP diluted EPS estimate excludes the impact of purchase accounting and merger-related adjustments, and stock option expense; |
| The Company anticipates that 2007 capital expenditures will be in the range of $250 $300 million. |
| Purchase accounting charges, including amortization of acquired intangible assets and IPR&D, is estimated to be in the range of $300 $315 million for already completed transactions; and | ||
| Stock options expense due to FAS 123R in 2007 is estimated to be in the range of $40 $55 million, or approximately $0.08 $0.11 per share. |
| On November 8th, AVONEX, the most prescribed MS therapy worldwide, launched in Japan. |
| On November 11th, Biogen Idec and Genentech announced positive results from interim analyses of ongoing open-label extension studies of RITUXAN therapy in patients with RA who have had an inadequate response to previous treatment with one or more tumor necrosis factor (TNF) antagonist therapies. Interim findings showed that a greater proportion of patients achieved an American College of Rheumatology (ACR) 20, 50 or 70 response following treatment with a subsequent course of RITUXAN, in combination with methotrexate (MTX), compared to outcomes after their first course. These findings, along with data on physical function and mental and physical health measures and a preliminary safety analysis of TNF antagonist use following RITUXAN treatment, have been presented at the ACR Annual Scientific Meeting. |
| On December 10th, Biogen Idec announced data from a Phase I/II study of an investigational anti-CD23 monoclonal antibody, lumiliximab, suggesting it may be synergistic with fludarabine, cyclophosphamide and rituximab (FCR), an emerging standard of care for chronic lymphocytic leukemia (CLL) patients. When added to the FCR regimen, lumiliximab demonstrated a 52 percent complete response (CR) rate in patients who have CLL that was progressing after prior therapy. The data were announced at the 48th Annual Meeting of the American Society of Hematology (ASH), held December 9-12 in Orlando. Based on the positive results of the trial, Biogen Idec is initiating a registrational global, multicenter clinical trial comparing lumiliximab plus FCR vs. FCR alone. |
| On December 15th, Biogen Idec and Elan announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval to market TYSABRI in the U.S. as a treatment for patients with moderately to severely active Crohns disease (CD). |
| On January 9th, Biogen Idec announced the initiation of the Phase III clinical program of BG-12, an oral fumarate in development for relapsing-remitting MS. |
| On January 25th, Biogen Idec announced the initiation of a Phase III randomized, double-blind study of an investigational anti-CD80 monoclonal antibody, galiximab, for patients with lymphoma. The trial will compare treatment with galiximab in combination with RITUXAN to RITUXAN in combination with placebo in patients with follicular NHL that has relapsed or failed to respond to initial therapy. |
| On January 31st, Biogen Idec completed its acquisition of Syntonix Pharmaceuticals. Syntonix will continue to focus on discovering and developing long-acting therapeutic products to improve treatment regimens for chronic diseases, and has multiple pre-clinical programs in hemophilia. The $40 million purchase price is subject to increase to as much as $120 million if certain development milestones with respect to Syntonixs lead product, FIX:Fc, are achieved, and we expect substantially all of the purchase price of Syntonix to be allocated to IPR&D. |
| On February 7th, Biogen Idec announced the initiation of a randomized, controlled, registration trial of an investigational anti-CD23 monoclonal antibody, lumiliximab, for patients with CLL. The trial will compare treatment with lumiliximab in combination FCR, an emerging standard of care, to FCR alone in patients with CLL that has relapsed or failed to respond to initial therapy. Lumiliximab has been granted Fast Track and Orphan Drug designations by the FDA for the above indication. Biogen Idec owns the worldwide rights to lumiliximab. |
(1) | Purchase accounting and merger-related adjustments Non-GAAP net income and diluted EPS exclude certain purchase accounting impacts such as those related to the merger with Biogen, Inc. (the Merger) and the acquisitions of Fumapharm AG and Conforma Therapeutics Corporation. These include charges for IPR&D and the incremental charge to cost of goods sold from our sale of acquired inventory that was written up to fair value at the acquisition date. Additionally, these excluded impacts include the incremental charges related to the amortization of the acquired intangible assets. Excluding these charges allows management and investors an alternative view of our financial results as if the acquired intangible asset had been developed internally rather than acquired and, therefore, provides a supplemental measure of performance in which the Companys acquired intellectual property is treated in a comparable manner to its internally developed intellectual property. |
(2) | Stock option expense and the cumulative effect of an accounting change relating to the initial adoption of SFAS No. 123R Non-GAAP net income and diluted EPS exclude the impact of our stock option expense recorded in accordance with SFAS No. 123R and the cumulative effect of an accounting change relating to its initial adoption. We believe that excluding the impact of expensing stock options and the adoption impact facilitates comparisons between 2006 and prior periods, which do not include a similar charge in reported, or GAAP, net income and diluted EPS. Additionally, in order to facilitate comparability between 2006 and prior periods, we do include the P&L impact of restricted stock awards and other cash incentives in our non-GAAP financials. |
(3) | Other items Non-GAAP net income and diluted EPS exclude other unusual or non-recurring items that are evaluated on an individual basis. Our evaluation of whether to exclude an item for purposes of determining our non-GAAP financial measures considers both the quantitative and qualitative aspects of the item, including, among other things (i) its size and nature, (ii) whether or not it relates to our ongoing business operations, and (iii) whether or not we expect it to occur as part of our normal business on a regular basis. Items excluded for purposes of determining non-GAAP net income and diluted EPS are gains and losses on the settlement of license agreements in connection with our Fumapharm AG acquisition and Fumedica transaction, gains and losses on the sale and impairments of long-lived assets and product lines, including Amevive and our Bio 1 facility, and severance and restructuring charges related to the planned ZEVALIN® (ibritumomab tiuxetan) disposition. |
Three Months Ended | Twelve Months Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2006 | 2005 | 2006 | 2005 | |||||||||||||
REVENUES |
||||||||||||||||
Product |
$ | 463,617 | $ | 429,231 | $ | 1,781,313 | $ | 1,617,004 | ||||||||
Unconsolidated joint business |
217,568 | 181,896 | 810,864 | 708,881 | ||||||||||||
Royalties |
25,517 | 21,594 | 86,231 | 93,193 | ||||||||||||
Corporate partner |
1,639 | 132 | 4,641 | 3,422 | ||||||||||||
Total revenues |
708,341 | 632,853 | 2,683,049 | 2,422,500 | ||||||||||||
COST AND EXPENSES |
||||||||||||||||
Cost of goods sold and royalties |
62,103 | 113,352 | 274,383 | 373,614 | ||||||||||||
Research and development |
199,480 | 168,314 | 718,390 | 747,671 | ||||||||||||
Selling, general and administrative |
186,945 | 169,122 | 685,067 | 644,758 | ||||||||||||
Amortization of acquired intangible assets |
60,020 | 73,558 | 266,998 | 302,305 | ||||||||||||
Collaboration profit (loss) sharing |
(4,393 | ) | | (9,682 | ) | | ||||||||||
Acquired in-process R&D |
| | 330,520 | | ||||||||||||
(Gain)/loss on sale and impairment of long lived assets, net |
(15,584 | ) | 15,208 | (16,507 | ) | 118,112 | ||||||||||
Loss/(gain) on settlement of license agreements, net |
28,052 | | (6,140 | ) | | |||||||||||
Total cost and expenses |
516,623 | 539,554 | 2,243,029 | 2,186,460 | ||||||||||||
Income from operations |
191,718 | 93,299 | 440,020 | 236,040 | ||||||||||||
Other (expense)/income, net |
(10,647 | ) | 11,837 | 52,143 | 20,155 | |||||||||||
INCOME BEFORE INCOME TAXES AND CUMULATIVE EFFECT
OF ACCOUNTING CHANGE |
181,071 | 105,136 | 492,163 | 256,195 | ||||||||||||
Income taxes |
72,515 | 49,574 | 278,431 | 95,484 | ||||||||||||
INCOME BEFORE CUMULATIVE EFFECT OF
ACCOUNTING CHANGE |
108,556 | 55,562 | 213,732 | 160,711 | ||||||||||||
Cumulative effect of accounting change, net of income tax |
| | 3,779 | | ||||||||||||
NET INCOME |
$ | 108,556 | $ | 55,562 | $ | 217,511 | $ | 160,711 | ||||||||
BASIC EARNINGS PER SHARE |
||||||||||||||||
Income before cumulative effect of accounting change |
$ | 0.32 | $ | 0.16 | $ | 0.63 | $ | 0.48 | ||||||||
Cumulative effect of accounting change, net of income tax |
| | 0.01 | | ||||||||||||
BASIC EARNINGS PER SHARE |
$ | 0.32 | $ | 0.16 | $ | 0.64 | $ | 0.48 | ||||||||
DILUTED EARNINGS PER SHARE |
||||||||||||||||
Income before cumulative effect of accounting change |
$ | 0.32 | $ | 0.16 | $ | 0.62 | $ | 0.47 | ||||||||
Cumulative effect of accounting change, net of income tax |
| | 0.01 | | ||||||||||||
DILUTED EARNINGS PER SHARE |
$ | 0.32 | $ | 0.16 | $ | 0.63 | $ | 0.47 | ||||||||
SHARES USED IN CALCULATING: |
||||||||||||||||
BASIC EARNINGS PER SHARE |
335,645 | 337,884 | 338,585 | 335,586 | ||||||||||||
DILUTED EARNINGS PER SHARE |
343,070 | 345,064 | 345,281 | 346,163 | ||||||||||||
December 31, | December 31, | |||||||
2006 | 2005 | |||||||
ASSETS |
||||||||
Cash, cash equivalents and securities available-for-sale |
$ | 902,691 | $ | 850,753 | ||||
Accounts receivable, net |
317,353 | 265,742 | ||||||
Inventory |
169,102 | 182,815 | ||||||
Other current assets |
323,421 | 318,771 | ||||||
Total current assets |
1,712,567 | 1,618,081 | ||||||
Long-term securities available-for-sale |
1,412,238 | 1,204,378 | ||||||
Property and equipment, net |
1,280,385 | 1,174,396 | ||||||
Intangible assets, net |
2,747,241 | 2,975,601 | ||||||
Goodwill |
1,154,757 | 1,130,430 | ||||||
Other |
245,620 | 264,061 | ||||||
TOTAL ASSETS |
$ | 8,552,808 | $ | 8,366,947 | ||||
LIABILITIES AND SHAREHOLDERS EQUITY |
||||||||
Current liabilities |
$ | 582,855 | $ | 583,036 | ||||
Long-term deferred tax liability |
643,645 | 762,282 | ||||||
Non-current liabilities |
176,530 | 115,753 | ||||||
Shareholders equity |
7,149,778 | 6,905,876 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
$ | 8,552,808 | $ | 8,366,947 | ||||
Three Months Ended | Twelve Months Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
EARNINGS PER SHARE | 2006 | 2005 | 2006 | 2005 | ||||||||||||
GAAP earnings per share Diluted |
$ | 0.32 | $ | 0.16 | $ | 0.63 | $ | 0.47 | ||||||||
Adjustment to net income (as detailed below) |
0.21 | 0.32 | 1.62 | 1.10 | ||||||||||||
Non-GAAP earnings per share Diluted |
$ | 0.53 | $ | 0.48 | $ | 2.25 | $ | 1.57 | ||||||||
GAAP net income |
$ | 108.6 | $ | 55.6 | $ | 217.5 | $ | 160.7 | ||||||||
Adjustments: |
||||||||||||||||
COGS: Fair value step up of inventory acquired from former
Biogen, Inc. and Fumapharm AG |
| 4.6 | 7.8 | 34.2 | ||||||||||||
COGS: Stock option expense |
| | 0.1 | | ||||||||||||
COGS: Amevive divestiture |
| 36.4 | | 36.4 | ||||||||||||
R&D: Costs associated with sale of Oceanside Manufacturing Facility |
| | | 1.9 | ||||||||||||
R&D: Severance and restructuring |
| 0.5 | 0.3 | 20.3 | ||||||||||||
R&D: Stock option expense |
2.9 | | 19.3 | | ||||||||||||
SG&A: Merger related and purchase accounting costs |
| | 0.1 | | ||||||||||||
SG&A: Severance and restructuring |
0.4 | 11.0 | 2.0 | 19.3 | ||||||||||||
SG&A: Stock option expense |
4.6 | | 28.9 | | ||||||||||||
Amortization of acquired intangible assets related to the
merger with former Biogen, Inc.,
Conforma Therapeutics Corporation and Fumapharm AG |
60.0 | 73.6 | 267.0 | 302.3 | ||||||||||||
In-process research and development related to the acquisition
of Conforma Therapeutics
Corporation and Fumapharm AG |
| | 330.5 | | ||||||||||||
Loss/(gain) on settlement of license agreement with
Fumedica and on settlement of license agreement with Fumapharm AG, net |
28.1 | | (6.1 | ) | | |||||||||||
(Gain)/loss on sale and impairment of long lived assets, net |
(15.6 | ) | 15.2 | (16.5 | ) | 111.8 | ||||||||||
Income taxes: Income tax effect of reconciling items |
(5.5 | ) | (32.3 | ) | (70.3 | ) | (145.2 | ) | ||||||||
Cumulative effect of accounting change from adoption of FAS123R, net
of income tax |
| | (3.8 | ) | | |||||||||||
Non-GAAP net income |
$ | 183.5 | $ | 164.6 | $ | 776.8 | $ | 541.7 | ||||||||
Three Months Ended | ||||||||
December 31, | ||||||||
2006 | 2005 | |||||||
PRODUCT REVENUES |
||||||||
Avonex® |
$ | 438,758 | $ | 413,002 | ||||
Amevive® |
376 | 12,353 | ||||||
Tysabri® |
17,569 | (196 | ) | |||||
Zevalin® |
3,879 | 4,072 | ||||||
Fumaderm® |
3,035 | | ||||||
Total product revenues |
$ | 463,617 | $ | 429,231 | ||||
Twelve Months Ended | ||||||||
December 31, | ||||||||
2006 | 2005 | |||||||
PRODUCT REVENUES |
||||||||
Avonex® |
$ | 1,706,719 | $ | 1,543,085 | ||||
Amevive® |
11,524 | 48,457 | ||||||
Tysabri® |
35,831 | ** | 4,656 | |||||
Zevalin® |
17,767 | 20,806 | ||||||
Fumaderm® |
9,472 | | ||||||
Total product revenues |
$ | 1,781,313 | $ | 1,617,004 | ||||
** | Biogen Idecs TYSABRI revenues for the twelve months ended December 31, 2006 includes $14 million of revenue that was deferred at the time of the initial TYSABRI launch in accordance with the Companys revenue recognition policy. The revenue was recognized in Q3 2006, as the ultimate disposition of the product was determined in that period. |
Exhibit 99.2
Biogen Idec Q4 and FY 2006 Earnings Conference Call and Webcast February 15, 2007 |
Safe Harbor Statement This presentation contains forward-looking statements about the launch of TYSABRI(r) (natalizumab) and our financial guidance for 2007. In addition, in the course of the presentation, we may provide additional information of a forward-looking nature. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from that which we expect. Important factors that could cause our actual results to differ include our continued dependence on our two principal products, the uncertainty of success in commercializing other products including the launch of TYSABRI(r), the occurrence of adverse safety events with our products, the failure to execute our growth strategy successfully or to compete effectively in our markets, our dependence on collaborations over which we may not always have full control, possible adverse impact of government regulation and changes in the availability of reimbursement for our products, problems with our manufacturing processes and our reliance on third parties, fluctuations in our operating results, our ability to protect our intellectual property rights and the cost of doing so, the risks of doing business internationally and the other risks and uncertainties that are described in our most recent Form 10-Q filing with the SEC. These forward-looking statements speak only as of the date of this presentation, and do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise. |
Q4 and FY 2006 Earnings Call Agenda Introduction Elizabeth Woo, VP Investor Relations Overview Jim Mullen, CEO Tysabri Launch Bob Hamm, SVP Neurology SBU Financial Performance Peter Kellogg, CFO Q&A ALL |
James Mullen Chief Executive Officer Business Overview |
Overview Executing on Three Key Value Drivers: Reinvestment in the Pipeline TYSABRI(r) Efficacy Delivering Long-Term Financial Results |
Business Development Momentum Six Deals In Less Than A Year HSP90 Inhibitors Oncology FUMADERM(r) (fumaric acid esters) Psoriasis BG-12 MS, Psoriasis Aviptadil PAH RNAi therapy PML CDP323 MS FIX:Fc & rFXIII Hemophilia May 2006 May 2006 September 2006 September 2006 October 2006 January 2007 |
Significant Reinvestment in the Pipeline Progress over last 12 months: Building business development momentum Expanding into new therapeutic areas Initiating late-stage registrational trials BG-12 for MS Galiximab (anti-CD80 MAb) for NHL Lumiliximab (anti-CD23 MAb) for CLL Adding talent David Parkinson M.D., SVP, Oncology R&D Cecil Pickett Ph.D., President, R&D |
TYSABRI(r) Launch Approach Phase 1 H2 2006 Prepare the Foundation Phase 2 2007 Reinforce Efficacy & Broaden Use RiskMAP & TOUCHTM education Infusion site capacity Payor access Benefit-Risk and Fair Balance Broaden use with proper patient selection Launch Focus |
Limitations of Current Therapies Partial or no response to ß IFNs & COPAXONE(tm) Flu-like symptoms Dosing too frequent Don't want injection responsibility/inconvenience Multiple Sclerosis Market Unmet Need Remains High TYSABRI(r) 2-year Phase 3 efficacy - Relapse rate reduced by 2/3 No flu-like symptoms Once every 4 weeks IV infusion done by healthcare provider Note: COPAXONE is a trademark of Teva Pharmaceutical Industries Ltd. |
AVONEX(r) & RITUXAN(r) Revenue Growth 2005 2006 AVONEX Worldwide Sales 1543 1707 2005 2006 BIIB Revenue 709 811 US Net Sales 1832 2071 AVONEX(r) RITUXAN(r) 11% 13% 14% |
2003 2004 2005 2006 Revenue 1.9 2.2 2.4 2.7 Delivering Long-Term Financial Results 2003 2004 2005 2006 non-GAAP 1.22 1.4 1.57 2.25 GAAP -4.92 0.07 0.47 0.63 $B 43% 23% 13% 11% ($4.92) 2003 - 2007 goal: 20% non-GAAP EPS CAGR |
Bob Hamm SVP, Neurology Strategic Business Unit TYSABRI(r) Launch |
TYSABRI(r) Launch Update Initial U.S. rollout of TOUCH program complete Patients seeking alternatives to existing products Patients switching from all therapies Nearly 10,000 patients prescribed TYSABRI(r) worldwide to date: International: ~1,600 patients U.S.: ~5,000 patients on therapy; ~3,000 patients in the queue Over 1,300 prescribing physicians in U.S. |
TYSABRI(r) Launch Status H2 2006 Launched H1 2007 H2 2007 Expected U.S. Germany Ireland Sweden Denmark Netherlands Finland Norway Austria UK Launched: Italy Canada Slovakia Expected: Luxembourg France Switzerland Spain Belgium Czech Republic Slovenia Portugal Australia Reimbursement in Place |
0.23 3-Year Analysis Relapse reduction sustained over 3 years 0.73 0.23 2-Year Analysis 42% reduction in risk of increased disability 68% p<0.001 TYSABRI(r) 2/3 Reduction in Relapses Placebo n=315 Natalizumab n=627 68% Annualized Relapse Rate (95% CI) 0.81 0.26 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 1-Year Analysis p<0.001 Note: Three year efficacy data presented at ECTRIMS 2006. 68% reduction in relapses published in New England Journal of Medicine and on E.U. prescribing information. U.S. prescribing information states 67% reduction in relapses. |
TYSABRI(r) MRI Efficacy Data Gd+ Lesions (2 yrs) % of patients with: Tysabri (n=627) Placebo (n=315) 0 lesions 97% 72% 1 lesion 2% 12% 2 or more lesions 1% 16% Note: Data from TYSABRI label p value <0.001 Gadolinium-enhancing - Currently active MS disease process T2-weighted hyperintense - Total brain tissue involved in disease process T2 Gd New or newly enlarging T2-hyperintense lesions (2 yrs) % of patients with: Tysabri (n=627) Placebo (n=315) 0 lesions 57% 15% 1 lesion 17% 10% 2 lesions 8% 8% 3 or more lesions 18% 68% Lesion Type |
ABCR Switcher 69% Other 31% TYSABRI(r) U.S. Source of Patients COPAXONETM most switched from product (January 2007) 34% 31% 15% 20% AVONEX(r) (interferon beta-1a) BETASERONTM (interferon beta-1b)* COPAXONETM (glatiramer acetate)* REBIFTM (interferon beta-1a)* January ABCR Switchers TYSABRI(r) source of business from launch Other Category: Returning quitter Other non- ABCR therapies Naive patients ABCR Switchers: AVONEX(r) BETASERONTM COPAXONETM REBIFTM Note: BETASERON is a trademark of Berlex, Inc.; REBIF is a trademark of Merck Serono S.A.; COPAXONE is a trademark of Teva Pharmaceutical Industries Ltd. |
TYSABRI(r) U.S. Reimbursement Status Update 95% of private payer patients have good access to TYSABRI(r) 40% of patients have no prior usage requirements 55% of patients have one agent prior usage required TYSABRI(r) has broad access within public payers 100% of Medicare patients have access to TYSABRI(r) per label 88% of Medicaid patients have access with no prior usage or one prior agent |
Start with AVONEX(r) ... For Lasting Efficacy $1.71 B $1.54 B Most prescribed MS therapy - 11 years as market leader +11% |
Multiple Therapeutic Approaches to MS T cell B cell DACLIZUMAB: Modifies the immune system response BG 12: Modifies the immune system response RITUXAN(r): Marks B-Cells for destruction NOGO: Triggers regeneration of nerves AVONEX(r): Modifies the immune system response LINGO: Repairs Myelin TYSABRI(r)/CDP 323: Prevents immune cells moving from bloodstream to tissues |
Leading Multiple Sclerosis Franchise AVONEX(r) - #1 prescribed MS therapy worldwide TYSABRI(r) - New level of efficacy Pipeline - Best and broadest for the future |
Peter Kellogg Chief Financial Officer Financial Performance |
Q4 and FY 2006 Financial Worksheet Revenues ($ millions) Q4 2005 Q4 2006 %D FY 2005 FY 2006 %D Notes AVONEX(r) U.S. Revenues 242 261 8% 939 1,022 9% AVONEX(r) International Revenues 171 178 4% 604 685 13% Total AVONEX(r) Sales 413 439 6% 1,543 1,707 11% TYSABRI(r) Revenue to BIIB (0.2) 18 - 5 36 620% Total Product Sales 429 464 8% 1,617 1,781 10% Revenue from Unconsolidated Joint Business [RITUXAN(r)] 182 218 20% 709 811 14% Royalties 22 26 18% 93 86 (8%) Total Revenue 633 708 12% 2,423 2,683 11% |
Q4 and FY 2006 Financial Worksheet Costs and Expenses ($ millions) Q4 2005 Q4 2006 %D FY 2005 FY 2006 %D Notes Non-GAAP Cost of Sales1 72 62 (14%) 303 266 (12%) % of Product Revenues 17% 13% 19% 15% Non-GAAP R&D Expenses2 168 197 17% 725 699 (4%) % of Total Revenues 27% 28% 30% 26% Non-GAAP SG&A Expenses3 158 182 15% 625 654 5% % of Total Revenues 25% 26% 26% 24% Collaboration Profit (Loss) Sharing [TYSABRI(r)] - (4.4) - (9.7) For Q4'05 GAAP COGS expense was $113.4 million and 26% of Product Revenues, and non-GAAP COGS expense of $72.4 million excludes $4.6 million in fair value step up of inventory acquired from former Biogen, Inc. and $36.4 million related to AMEVIVE divestiture. For Q4'06 GAAP COGS expense was $62.1 million and 13% of Product Revenues, and there were no adjustments to a non-GAAP COGS expense. For 2005 GAAP COGS expense was $373.6 million and 23% of Total Revenues, and non-GAAP COGS expense of $303.0 million excludes $34.2 million in fair value step up of inventory acquired from former Biogen, Inc. and $36.4 million related to AMEVIVE divestiture. For 2006 GAAP COGS expense was $274.4 million and 15% of Product Revenues, and non-GAAP COGS expense of $266.5 million excludes $7.8 million in fair value step up of inventory acquired from former Biogen, Inc. and Fumapharm AG and $0.1 million in stock option expense. For Q4'05 GAAP R&D expense was $168.3 million and 27% of Total Revenues, and non-GAAP R&D expense of $167.8 million excludes $0.5 million in severance and restructuring. For Q4'06 GAAP R&D expense was $199.5 million and 28% of Total Revenues, and non-GAAP R&D expense of $196.6 million excludes $2.9 million in stock option expense. For 2005 GAAP R&D expense was $747.7 million and 31% of Total Revenues, and non-GAAP R&D expense of $725.5 million excludes $1.9 million in costs associated with sale of Oceanside manufacturing facility and $20.3 million in severance and restructuring. For 2006 GAAP R&D expense was $718.4 million and 27% of Total Revenues, and non-GAAP R&D expense of $698.8 million excludes $0.3 million in severance and restructuring and $19.3 million in stock option expense. For Q4'05 GAAP SG&A expense was $169.1 million and 27% of Total Revenues, and non-GAAP SG&A expense of $158.1 million excludes $11.0 million in severance and restructuring. For Q4'06 GAAP SG&A expense was $186.9 million and 26% of Total Revenues, and non-GAAP SG&A expense of $181.9 million excludes $0.4 million in severance and restructuring and $4.6 million in stock option expense. For 2005 GAAP SG&A expense was $644.8 million and 27% of Total Revenues, and non- GAAP SG&A expense of $625.5 million excludes $19.3 million in severance and restructuring. For 2006 GAAP SG&A expense was $685.1 million and 26% of Total Revenues, and non-GAAP SG&A expense of $654.1 million excludes $0.1 million in merger related and purchase accounting costs, $2.0 million in severance and restructuring and $28.9 million in stock option expense. |
Q4 and FY 2006 Financial Worksheet Other Selected Financials ($ millions) Q4 2005 Q4 2006 %D FY 2005 FY 2006 %D Notes Other income, Net $12 ($11) - $20 $52 160% Non-GAAP Tax Rate1 33% 30% 31% 31% Non-GAAP Net Income2 $165 $184 12% $542 $777 43% Weighted Average Shares Outstanding (millions) 345 343 346 345 Non-GAAP EPS2 $0.48 $0.53 10% $1.57 $2.25 43% For Q4'05 GAAP tax rate was 47%. For Q4'06 GAAP tax rate was 40%. For 2005 GAAP tax rate was 37%. For 2006 GAAP tax rate was 57%. The difference between the GAAP tax rate to the non-GAAP tax rate for all periods is a result of the reconciliation that can be found on Table 3 from Biogen Idec's Q4 2006 earnings press release or slide 30 of this presentation and the footnotes to slide 24 of this presentation. See Table 3 from Biogen Idec's Q4 2006 earnings press release or slide 30 of this presentation for the most directly comparable GAAP net income and diluted GAAP EPS, with a reconciliation to the non-GAAP net income and diluted non-GAAP EPS. |
2007 Financial Guidance Mid-teens revenue growth Key drivers: TYSABRI(r) and RITUXAN(r) RA launches Similar margins as 2006 Except for R&D: Expected to be 27 - 29% of Total Revenues Assumes slightly higher level of new business development Non-GAAP EPS $2.50 - $2.65 Excludes FAS123R stock option expensing of $0.08 - 0.11 Excludes purchase accounting and merger-related accounting impacts GAAP EPS guidance $1.69 - $1.84 Capital Expenditures $250 - $300 million |
James Mullen Chief Executive Officer Summary |
2007 Focus Driving TYSABRI Business Development Organic pipeline Initiating several proof-of-concept trials May 17th R&D Day hosted by Cecil Pickett Delivering financial results to achieve long-term growth goals |
Reconciliation |
GAAP to non-GAAP Reconciliation Diluted EPS and Net Income: Q4/FY 2005 & 2006 Note: Numbers may not foot due to rounding. |
GAAP to non-GAAP Reconciliation Diluted EPS and Net Income: Four Year History Condensed Consolidated Statements of Income - Operating Basis FY 2003 FY 2004 FY 2005 FY 2006 GAAP diluted EPS ($4.92) $0.07 $0.47 $0.63 Adjustment to net income (see below) 6.14 1.38 1.10 1.62 Effect of FAS128 and ETIF 0306 - (0.05) - - Non-GAAP diluted EPS $1.22 $1.40 $1.57 $2.25 GAAP Net Income ($M) ($875.1) $25.1 $160.7 $217.5 Revenue - Pre-merger Biogen product, royalty and corporate partner revenue 1173.1 - - - COGS - Fair value step up of inventory acquired from Biogen and Fumapharm 231.6 295.5 34.2 7.8 COGS - Pre-merger Biogen cost of sales (179.2) - - - COGS - Royalties related to Corixa 1.8 - - - COGS - Amevive divesture - - 36.4 - R&D - Pre-merger Biogen net R&D (301.1) - - - R&D - Severance and restructuring - 3.1 20.3 0.3 R&D - Sale of plant - - 1.9 - SG&A - Pre-merger Biogen SG&A (346.7) - - - SG&A - Merger related and purchase accounting costs - - - 0.1 SG&A - Severance and restructuring 13.2 9.3 19.3 2.0 Amortization of intangible assets primarily related to Biogen merger 33.2 347.7 302.3 267.0 Acquisition of in-process R&D related to Biogen and Idec merger and Conforma and Fumapharm acquisitions 823.0 - - 330.5 Loss/(gain) on settlement of license agreements with Fumedica and Fumapharm - - - (6.1) (Gain)/loss on sale of long lived assets - - 111.8 (16.5) Pre-merger Biogen other income 32.9 - - - Write down of investments - 12.7 - - Charitable donations and legal settlements 30.7 - - - Income taxes - Effect of reconciling items (205.8) (195.4) (145.2) (70.3) Stock option expense - - - 44.5 Non-GAAP Net Income $431.7 $498.0 $541.7 $776.8 Source: Biogen Idec Annual Reports, 10-K filings and earnings press releases (FY 2003-2005) and 2006 earnings press release. |
Questions & Answers |