0001193125-12-178878.txt : 20120424 0001193125-12-178878.hdr.sgml : 20120424 20120424162104 ACCESSION NUMBER: 0001193125-12-178878 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20120424 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20120424 DATE AS OF CHANGE: 20120424 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AMGEN INC CENTRAL INDEX KEY: 0000318154 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 953540776 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-12477 FILM NUMBER: 12776276 BUSINESS ADDRESS: STREET 1: ONE AMGEN CENTER DRIVE CITY: THOUSAND OAKS STATE: CA ZIP: 91320 BUSINESS PHONE: (805)447-1000 MAIL ADDRESS: STREET 1: ONE AMGEN CENTER DRIVE CITY: THOUSAND OAKS STATE: CA ZIP: 91320 FORMER COMPANY: FORMER CONFORMED NAME: AMGEN DATE OF NAME CHANGE: 19870305 8-K 1 d339480d8k.htm FORM 8-K Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported)

April 24, 2012

 

 

AMGEN INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   000-12477   95-3540776

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

One Amgen Center Drive

Thousand Oaks, CA

  91320-1799
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code

805-447-1000

N/A

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

 


Item 2.02 Results of Operations and Financial Condition.

On April 24, 2012, Amgen Inc. (the Company) issued a press release announcing its unaudited results of operations for the three months ended March 31, 2012 and its unaudited financial position as of March 31, 2012. The full text of the press release is set forth in Exhibit 99.1 attached hereto.

In its press release the Company included certain historical non-U.S. Generally Accepted Accounting Principles (non-GAAP) financial measures as defined in Regulation G promulgated by the Securities and Exchange Commission with respect to March 31, 2012 and for the three months ended March 31, 2012 and 2011. Reconciliations for such historical non-GAAP financial measures are attached to the press release set forth as Exhibit 99.1 attached hereto. The Company believes that its presentation of historical non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. These historical non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with U.S. Generally Accepted Accounting Principles (GAAP).

As of March 31, 2012

As of March 31, 2012, the Company reported a non-GAAP financial measure for total outstanding debt which excluded the impact of bifurcating the debt and equity components of its convertible notes as required by U.S. accounting standards for these securities commencing in 2009. The Company believes that excluding this impact provides a supplemental measure of financial condition that will facilitate comparisons before, during and after its convertible notes are outstanding.

Three months ended March 31, 2012

For the three months ended March 31, 2012, the Company’s adjustments to GAAP financial measures relate to amounts associated with:

 

   

the incremental expense resulting from accelerating depreciation as a result of our transaction with Boehringer Ingelheim (BI) involving our Fremont, California manufacturing facility (the 2012 BI Fremont Transaction Expense);

 

   

the impact of expensing stock options;

 

   

acquisition related expenses;

 

   

the non-cash amortization of product technology rights acquired in a prior year business combination (the Product Technology Rights’ Amortization);

 

   

certain charges, pursuant to our continuing efforts to improve cost efficiencies in our operations in 2011 (the Cost-Savings Initiatives Expense);

 

   

the expense resulting from changes in the estimated fair values of the contingent consideration obligations related to a prior year business combination (the Contingent Consideration Costs);

 

   

the expense related to certain legal proceedings (the Legal Expense);

 

   

the non-cash interest expense associated with our convertible notes (the Non-Cash Interest Expense); and

 

   

the tax effect of the adjustments above in 2012 (the 2012 Tax Effect).

For the three months ended March 31, 2012, the Company reported non-GAAP financial results for cost of sales (excludes amortization of certain acquired intangible assets) (COS) expense, research and development (R&D) expense, selling, general and administrative (SG&A) expense, and weighted average shares used in the calculation of adjusted diluted earnings per share:

 

   

COS expense, R&D expense and SG&A expense were adjusted to exclude the effects of expensing stock options;

 

   

COS expense was also adjusted to exclude the 2012 BI Fremont Transaction Expense;

 

   

R&D expense and SG&A expense were also adjusted to exclude the effects of the acquisition-related expenses; and

 

   

weighted average shares used in the calculation of adjusted diluted earnings per share were adjusted to exclude the related effects of expensing stock options.

The Company believes that excluding the impact of expensing stock options and the related effects of expensing stock options provide supplemental measures of profitability that will facilitate comparisons between periods before and during when such expenses are incurred. The Company believes that excluding the 2012 BI Fremont Transaction Expense and the acquisition-related expenses provide supplemental measures of profitability that will facilitate comparisons before, during and after such expenses are incurred.

For the three months ended March 31, 2012, the Company reported non-GAAP provision for income taxes, non-GAAP net income and non-GAAP earnings per share excluding, where applicable:

 

   

the foregoing expense amounts and the related effects of expensing stock options on weighted average shares used in the calculation of adjusted diluted earnings per share for the reasons discussed above;

 

   

the Product Technology Rights’ Amortization;

 

   

the Cost-Savings Initiatives Expense;

 

   

the Contingent Consideration Costs;

 

   

the Legal Expense;

 

   

the Non-Cash Interest Expense; and

 

   

the 2012 Tax Effect.

The Company believes that excluding the Product Technology Rights’ Amortization treats those assets as if the Company had developed them internally in the past, and thus provides a supplemental measure of profitability in which the Company’s acquired intellectual property is treated in a comparable manner to its internally developed intellectual property. The Company believes that excluding the Cost-Savings Initiatives Expense and the Legal Expense provides supplemental measures of profitability that will facilitate comparisons between periods in which such items did not occur. The Company believes that excluding the Contingent Consideration Costs and the Non-Cash Interest Expense provide supplemental measures of profitability that will facilitate comparisons before, during and after such expenses are incurred. The Company believes that excluding the 2012 Tax Effect provides a supplemental measure of profitability that will facilitate comparisons before, during and after the related adjustments have occurred.


Three months ended March 31, 2011

For the three months ended March 31, 2011, the Company’s adjustments to GAAP financial measures relate to amounts associated with:

 

   

the impact of expensing stock options;

 

   

the incremental expense resulting from accelerating depreciation and accruing losses for facility operating leases as a result of our transaction with BI involving our Fremont, California manufacturing facility (the 2011 BI Fremont Transaction Expense);

 

   

the non-cash amortization of R&D technology intangible assets acquired in business combinations in prior years (the R&D Technology Intangible Assets’ Amortization);

 

   

acquisition-related expenses;

 

   

the Product Technology Rights’ Amortization;

 

   

the Cost-Savings Initiatives Expense;

 

   

the Non-Cash Interest Expense;

 

   

the tax effect of the adjustments above in 2011 (the 2011 Tax Effect); and

 

   

the income tax benefit related to certain prior period charges excluded from adjusted earnings (the 2011 Prior Period Charges Tax Benefit).

For the three months ended March 31, 2011, the Company reported non-GAAP financial results for COS expense, R&D expense, SG&A expense, and weighted average shares used in the calculation of adjusted diluted earnings per share:

 

   

COS expense, R&D expense and SG&A expense were adjusted to exclude the effects of expensing stock options;

 

   

COS expense was also adjusted to exclude the 2011 BI Fremont Transaction Expense;

 

   

R&D expense was also adjusted to exclude the R&D Technology Intangible Assets’ Amortization and the effects of the acquisition-related expenses;

 

   

SG&A expense was also adjusted to exclude the effects of the acquisition-related expenses; and

 

   

weighted average shares used in the calculation of adjusted diluted earnings per share were adjusted to exclude the related effects of expensing stock options.

The Company believes that excluding the impact of expensing stock options and the related effects of expensing stock options provide supplemental measures that will facilitate comparisons between periods before and during when such expenses are incurred. The Company believes that excluding the 2011 BI Fremont Transaction Expense and the acquisition-related expenses provide supplemental measures of profitability that will facilitate comparisons before, during and after such expenses are incurred. The Company believes that excluding the R&D Technology Intangible Assets’ Amortization treats those assets as if the Company had developed them internally in the past, and thus provides a supplemental measure of profitability in which the Company’s acquired intellectual property is treated in a comparable manner to its internally developed intellectual property.

For the three months ended March 31, 2011, the Company reported non-GAAP adjusted provision for income taxes, adjusted net income and adjusted earnings per share excluding, where applicable:

 

   

the foregoing expense amounts and the related effects of expensing stock options on weighted average shares used in the calculation of adjusted diluted earnings per share for the reasons discussed above;

 

   

the Product Technology Rights’ Amortization;

 

   

the Cost-Savings Initiatives Expense;

 

   

the Non-Cash Interest Expense;

 

   

the 2011 Tax Effect; and

 

   

the 2011 Prior Period Charges Tax Benefit.

The Company believes that excluding the Product Technology Rights’ Amortization treats those assets as if the Company had developed them internally in the past, and thus provides a supplemental measure of profitability in which the Company’s acquired intellectual property is treated in a comparable manner to its internally developed intellectual property. The Company believes that excluding the Cost-Savings Initiatives Expense and the 2011 Prior Period Charges Tax Benefit provide supplemental measures that will facilitate comparisons between periods in which such items did not occur. The Company believes that excluding the Non-Cash Interest Expense provides a supplemental measure of profitability that will facilitate comparisons before, during and after such expense is incurred. The Company believes that excluding the 2011 Tax Effect provides a supplemental measure of profitability that will facilitate comparisons before, during and after the related adjustments have occurred.

The Company uses the foregoing non-GAAP financial measures in connection with its own budgeting and financial planning.

Due to the differing treatments of expensing stock options for the purpose of presenting adjusted earnings per share within and across industries, the Company also reported non-GAAP adjusted earnings per share including the impact of expensing stock options for the three months ended March 31, 2012 and 2011, as a convenience to investors.


Item 9.01 Financial Statements and Exhibits.

(c) Exhibits.

 

99.1    Press Release dated April 24, 2012


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    AMGEN INC.
Date: April 24, 2012     By:  

/s/ Jonathan M. Peacock

    Name:   Jonathan M. Peacock
    Title:   Executive Vice President and Chief Financial Officer


EXHIBIT INDEX

 

Exhibit

Number

  

Document Description

99.1    Press release dated April 24, 2012
EX-99.1 2 d339480dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

 

LOGO

  
  

One Amgen Center Drive

Thousand Oaks, CA 91320-1799

Telephone 805-447-1000

www.amgen.com

News Release   

AMGEN’S FIRST QUARTER 2012 REVENUE

INCREASED 9 PERCENT TO $4.0 BILLION AND

ADJUSTED EARNINGS PER SHARE (EPS)

INCREASED 20 PERCENT TO $1.61

 

 

First Quarter 2012 GAAP EPS Increased

23 Percent to $1.48

THOUSAND OAKS, Calif. (April 24, 2012) – Amgen (NASDAQ:AMGN) reported total revenue increased 9 percent during the first quarter of 2012 to $4,048 million versus $3,706 million in the first quarter of 2011.

Adjusted earnings per share (EPS) were $1.61 for the first quarter of 2012, an increase of 20 percent compared to $1.34 for the first quarter of 2011. Adjusted net income increased 2 percent to $1,287 million in the first quarter of 2012 compared to $1,258 million in the first quarter of 2011.

“We delivered strong sales and earnings during the first quarter, reflecting broad strength across the portfolio”, said Kevin Sharer, chairman & CEO. “The pipeline is developing well and the business is in good shape to address the opportunities and challenges ahead,” concluded Sharer.

Adjusted EPS and adjusted net income for the first quarter of 2012 and 2011 exclude, for the applicable periods, certain expenses related to acquisitions and cost-savings initiatives, non-cash interest expense associated with our convertible notes and certain other items. These adjustments and other items are presented on the attached reconciliations.

On a reported basis in accordance with United States (U.S.) Generally Accepted Accounting Principles (GAAP), Amgen’s GAAP diluted EPS were $1.48 for the first quarter of 2012, an increase of 23 percent compared to $1.20 for the first quarter of 2011. GAAP net income increased 5 percent to $1,184 million in the first quarter of 2012 compared to $1,125 million for the first quarter of 2011.


First Quarter 2012 Revenue Increased 9 Percent to $4.0 Billion and Adjusted

Earnings Per Share Increased 20 Percent to $1.61

Page 2

 

Product Sales Performance

Total product sales increased 8 percent to $3,901 million in the first quarter of 2012 versus $3,618 million in the first quarter of 2011. U.S. product sales increased 8 percent to $2,997 million in the first quarter of 2012 versus $2,778 million in the first quarter of 2011. International product sales increased 8 percent to $904 million in the first quarter of 2012 versus $840 million in the first quarter of 2011. The impact of foreign exchange on international product sales for the first quarter of 2012 was not material.

XGEVA® (denosumab) sales were $153 million in the first quarter of 2012, an increase of 14 percent over the fourth quarter of 2011, reflecting increased segment share as well as overall segment growth.

Prolia® (denosumab) sales were $88 million in the first quarter of 2012, an increase of 9 percent over the fourth quarter of 2011, reflecting continued global growth.

Combined Neulasta® (pegfilgrastim) and NEUPOGEN® (Filgrastim) sales increased 9 percent to $1,344 million in the first quarter of 2012 versus $1,232 million in the first quarter of 2011. Combined U.S. Neulasta and NEUPOGEN sales increased 13 percent to $1,053 million in the first quarter of 2012 versus $930 million in the first quarter of 2011, driven primarily by an increase in the average net sales price and, to a lesser extent, an increase in Neulasta unit demand. Combined Neulasta and NEUPOGEN international sales decreased 4 percent to $291 million in the first quarter of 2012 versus $302 million in the first quarter of 2011, due primarily to a decrease in the average net sales price. A mid single-digit percentage point increase in Neulasta unit demand was offset by a decline in NEUPOGEN units due primarily to biosimilar competition.

Enbrel® (etanercept) sales increased 7 percent to $938 million in the first quarter of 2012 versus $875 million in the first quarter 2011, driven primarily by an increase in the average net sales price. ENBREL remains the segment share leader in both the rheumatology and dermatology segments.

Aranesp® (darbepoetin alfa) sales decreased 11 percent to $518 million in the first quarter of 2012 versus $580 million in the first quarter of 2011. U.S. Aranesp sales decreased 19 percent to $202 million in the first quarter of 2012 versus $250 million in the first quarter of 2011, due primarily to a decline in unit demand, offset partially by a mid single-digit percentage point increase in the average net sales price. The unit decline reflects segment contraction resulting from changes to the product label and reimbursement environment that occurred during 2011. International Aranesp sales decreased 4 percent to $316 million in the first quarter of 2012 versus $330 million in the first quarter of 2011, due primarily to a decrease in the average net sales price.

EPOGEN® (epoetin alfa) sales decreased 17 percent to $446 million in the first quarter of 2012 versus $535 million in the first quarter of 2011, reflecting the impact of changes to the label and reimbursement. The decline was comprised of an approximately 30 percent decrease in unit demand driven by a reduction in dose utilization, offset partially by reductions in customer discounts as part of new provider contracts that became effective Jan. 1, 2012.


First Quarter 2012 Revenue Increased 9 Percent to $4.0 Billion and Adjusted

Earnings Per Share Increased 20 Percent to $1.61

Page 3

 

On a sequential basis, EPOGEN sales decreased 8 percent, comprised of an approximately 20 percent decrease in unit demand driven by the timing of end-user purchases at the end of 2011 and a reduction in dose utilization. These decreases were offset partially by reductions in customer discounts as part of new provider contracts.

Sales of our other, growth-phase products increased 22 percent to $399 million in the first quarter 2012 versus $327 million in the first quarter of 2011. Sales of Sensipar®/Mimpara® (cinacalcet) increased 17 percent to $219 million in the first quarter of 2012 versus $187 million in the first quarter of 2011. Sales of Vectibix® (panitumumab) increased 20 percent to $90 million in the first quarter of 2012 versus $75 million in the first quarter of 2011. Sales of Nplate® (romiplostim) increased 38 percent to $90 million in the first quarter of 2012 versus $65 million in the first quarter of 2011. These increases were driven primarily by global unit growth.

Operating Expense Analysis on an Adjusted Basis:

Cost of sales increased to 17.1 percent of sales in the first quarter of 2012 versus 14.9 percent of sales in the first quarter of 2011. Excluding the impact of the Puerto Rico excise tax, cost of sales would have been 15.0 percent of sales for the first quarter of 2012 versus 14.6 percent of sales for the first quarter of 2011 driven primarily by higher inventory write-offs.

Research & Development (R&D) expenses increased 3 percent to $723 million in the first quarter of 2012 versus $703 million in the first quarter of 2011. The increase was due to higher costs associated with supporting our later stage clinical programs including AMG 145, AMG 785 and talimogene laherparepvec. This increase was offset partially by reduced expenses in Discovery Research and Translational Sciences.

Selling, General & Administrative (SG&A) expenses increased 5 percent to $1,057 million in the first quarter of 2012 versus $1,011 million in the first quarter of 2011. This increase was driven principally by higher spending on marketed products, related primarily to the launch of ENBREL and Prolia direct-to-consumer advertising campaigns as well as international expansion, and by increased ENBREL profit share expenses. These increases were offset partially by a favorable change to the estimated 2011 U.S. healthcare reform federal excise fee.

The adjusted tax rate for the first quarter of 2012 was 15.6 percent compared with 16.6 percent for the first quarter of 2011. The decrease was due primarily to changes in revenue and expense mix, the aforementioned adjustment to the non-deductible healthcare reform federal excise fee, and additional foreign tax credits associated with the Puerto Rico excise tax. This decrease was offset partially by the federal R&D credit benefit in the first quarter of 2011. As of March 31, 2012, the U.S. Congress had not extended the R&D tax credit that expired at the end of 2011. Excluding the impact of the Puerto Rico excise tax, the adjusted tax rate for the first quarter of 2012 would have been 20.2 percent versus 20.9 percent in the first quarter of 2011.


First Quarter 2012 Revenue Increased 9 Percent to $4.0 Billion and Adjusted

Earnings Per Share Increased 20 Percent to $1.61

Page 4

 

During the first quarter of 2012, Amgen repurchased approximately 21 million shares of common stock at a total cost of $1.4 billion. The Company currently has $3.6 billion remaining under its authorized stock repurchase program.

The Company previously announced that its Board of Directors declared a $0.36 per share dividend for the second quarter of 2012. The dividend will be paid on June 7, 2012, to all stockholders of record as of the close of business on May 16, 2012.

Average diluted shares for adjusted EPS for the first quarter of 2012 were 799 million versus 940 million for the first quarter of 2011.

Capital expenditures for the first quarter of 2012 were $129 million versus $100 million in the first quarter of 2011. Operating cash flow for the first quarter of 2012 was $1.0 billion, approximately the same as the first quarter of 2011. Worldwide cash and marketable securities were $19.4 billion and adjusted outstanding debt was $21.5 billion as of March 31, 2012.

2012 Guidance

The Company continues to expect 2012 total revenue to be in the range of $16.1 billion to $16.5 billion, and 2012 adjusted EPS to be in the range of $5.90 to $6.15, excluding certain expenses related to acquisitions and cost-savings initiatives, non-cash interest expense associated with our convertible notes and certain other items.

With respect to other guidance, Amgen continues to expect the adjusted tax rate for 2012 to be in the range of 14 percent to 15 percent. Excluding the Puerto Rico excise tax, Amgen still expects the adjusted tax rate for 2012 to be in the range of 19 percent to 20 percent.

The Company still expects 2012 capital expenditures to be approximately $700 million.

First Quarter Product and Pipeline Update

The Company provided the following information on selected products and clinical programs:

AMG 145: The Company discussed recently presented positive results from a Phase 1b clinical study in patients with high cholesterol who were taking statins. The Company also announced that four Phase 2 studies in subjects with high cholesterol had completed enrollment.

AMG 785: The Company discussed the recent initiation of a Phase 3 clinical study for the treatment of postmenopausal osteoporosis.

Brodalumab (AMG 827): The Company discussed the recent publication of positive results from a Phase 2 clinical study in patients with psoriasis and plans to commence Phase 3 clinical studies in 2012.


First Quarter 2012 Revenue Increased 9 Percent to $4.0 Billion and Adjusted

Earnings Per Share Increased 20 Percent to $1.61

Page 5

 

The Company discussed the collaboration with AstraZeneca Plc announced on April 2 to jointly develop and commercialize five monoclonal antibodies from Amgen’s clinical inflammation portfolio.

The Company discussed the agreement announced on April 10 under which Amgen will acquire KAI, a privately held pharmaceutical company based in South San Francisco. The acquisition is subject to customary closing conditions.

Non-GAAP Financial Measures

Management has presented its operating results in accordance with GAAP and on an “adjusted” (or non-GAAP) basis for the three months ended March 31, 2012 and 2011. In addition, management has presented its outstanding debt in accordance with GAAP and on an “adjusted” (or non-GAAP) basis as of March 31, 2012. The Company believes that the presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. The Company uses these non-GAAP financial measures in connection with its own budgeting and financial planning. These non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in conformity with GAAP. Further, our reconciliations of GAAP to “adjusted” operating results, which are included on the attached tables, are presented in the format of condensed consolidated statements of income solely to facilitate a reader’s understanding of the impact of the various adjustments to our GAAP operating results, individually and in the aggregate, and are not intended to place any undue prominence on our adjusted operating results.

About Amgen

Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab to manufacturing plant to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. To learn more about our pioneering science and vital medicines, visit www.amgen.com. Follow us on www.twitter.com/amgen.

Forward-Looking Statements

This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in our Form 10-K for the year ended Dec. 31, 2011, and in our periodic reports on Form 10-Q and Form 8-K. Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. The Company’s results may be affected by our ability to


First Quarter 2012 Revenue Increased 9 Percent to $4.0 Billion and Adjusted

Earnings Per Share Increased 20 Percent to $1.61

Page 6

 

successfully market both new and existing products domestically and internationally, clinical and regulatory developments (domestic or foreign) involving current and future products, sales growth of recently launched products, competition from other products (domestic or foreign) and difficulties or delays in manufacturing our products. In addition, sales of our products are affected by reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and health care cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others’ regulations and reimbursement policies may affect the development, usage and pricing of our products. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We, or others, could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock.

CONTACT: Amgen, Thousand Oaks

Christine Regan, 805-447-5476 (media)

Arvind Sood, 805-447-1060 (investors)

###


First Quarter 2012 Revenue Increased 9 Percent to $4.0 Billion and Adjusted

Earnings Per Share Increased 20 Percent to $1.61

Page 7

 

Amgen Inc.

Condensed Consolidated Statements of Income and

Reconciliation of GAAP Earnings to “Adjusted” Earnings

(In millions, except per share data)

(Unaudited)

 

     Three months ended
March 31, 2012
     Three months ended
March 31, 2011
 
     GAAP      Adjustments     “Adjusted”      GAAP      Adjustments     “Adjusted”  

Revenues:

               

Product sales

   $ 3,901       $ —        $ 3,901       $ 3,618       $ —        $ 3,618   

Other revenues

     147         —          147         88         —          88   
  

 

 

    

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Total revenues

     4,048         —          4,048         3,706         —          3,706   
  

 

 

    

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Operating expenses:

               

Cost of sales (excludes amortization of certain acquired intangible assets presented below)

     679         (13 ) (a)      666         564         (24 (a)      540   

Research and development

     736         (13 ) (b)      723         736         (33 (b)      703   

Selling, general and administrative

     1,076         (19 ) (c)      1,057         1,023         (12 (c)      1,011   

Amortization of certain acquired intangible assets

     74         (74 ) (d)      —           74         (74 (d)      —     

Other

     6         (6 ) (e)      —           16         (16 (e)      —     
  

 

 

    

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Total operating expenses

     2,571         (125     2,446         2,413         (159     2,254   
  

 

 

    

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Operating income

     1,477         125        1,602         1,293         159        1,452   

Interest expense, net

     235         (34 ) (f)      201         135         (44 (f)      91   

Interest and other income, net

     124         —          124         148         —          148   
  

 

 

    

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Income before income taxes

     1,366         159        1,525         1,306         203        1,509   

Provision for income taxes

     182         56   (g)      238         181         70   (g)      251   
  

 

 

    

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Net income

   $ 1,184       $ 103      $ 1,287       $ 1,125       $ 133      $ 1,258   
  

 

 

    

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Earnings per share:

               

Basic

   $ 1.50         $ 1.63       $ 1.21         $ 1.35   

Diluted (h)

   $ 1.48         $ 1.61       $ 1.20         $ 1.34   

Average shares used in calculation of earnings per share:

               

Basic

     791           791         933           933   

Diluted (h)

     800           799         941           940   

(a) - (h) See explanatory notes on the following pages.


First Quarter 2012 Revenue Increased 9 Percent to $4.0 Billion and Adjusted

Earnings Per Share Increased 20 Percent to $1.61

Page 8

 

Amgen Inc.

Notes to Reconciliation of GAAP Earnings to “Adjusted” Earnings

(In millions, except per share data)

(Unaudited)

 

     Three months ended
March 31,
 
     2012     2011  

(a)  Adjustments to cost of sales:

    

Incremental expense resulting from accelerating depreciation and/or accruing losses for facility operating leases as a result of our transaction with Boehringer Ingelheim involving our Fremont, California manufacturing facility (the BI transaction)

   $ (10   $ (21

Stock option expense (i)

     (3     (3
  

 

 

   

 

 

 

Total adjustments to cost of sales

   $ (13   $ (24
  

 

 

   

 

 

 

(b)  Adjustments to research and development expenses:

    

Acquisition-related expenses

   $ (7   $ (7

Non-cash amortization of R&D technology intangible assets acquired in business combinations in prior years

     —          (17

Stock option expense (i)

     (6     (9
  

 

 

   

 

 

 

Total adjustments to research and development expenses

   $ (13   $ (33
  

 

 

   

 

 

 

(c)  Adjustments to selling, general and administrative expenses:

    

Acquisition-related expenses

   $ (12   $ (2

Stock option expense (i)

     (7     (10
  

 

 

   

 

 

 

Total adjustments to selling, general and administrative expenses

   $ (19   $ (12
  

 

 

   

 

 

 

(d)  Adjustments to amortization of certain acquired intangible assets:

    

Non-cash amortization of product technology rights acquired in a prior year business combination

   $ (74   $ (74
  

 

 

   

 

 

 

(e)  Adjustments to other operating expenses:

    

Certain charges pursuant to our continuing efforts to improve cost efficiencies in our operations

   $ (1   $ (16

Expense resulting from changes in the estimated fair values of the contingent consideration obligations related to a prior year business combination

     (2     —     

Expense related to certain legal proceedings

     (3     —     
  

 

 

   

 

 

 

Total adjustments to other operating expenses

   $ (6   $ (16
  

 

 

   

 

 

 

(f)  Adjustments to interest expense, net:

    

Non-cash interest expense associated with our convertible notes

   $ (34   $ (44
  

 

 

   

 

 

 

(g)  Adjustments to provision for income taxes:

    

Income tax effect of the above adjustments (j)

   $ 56      $ 65   

Income tax benefit related to certain prior period charges excluded from “Adjusted” earnings

     —          5   
  

 

 

   

 

 

 

Total adjustments to provision for income taxes

   $ 56      $ 70   
  

 

 

   

 

 

 


First Quarter 2012 Revenue Increased 9 Percent to $4.0 Billion and Adjusted

Earnings Per Share Increased 20 Percent to $1.61

Page 9

 

Amgen Inc.

Notes to Reconciliation of GAAP Earnings to “Adjusted” Earnings

(In millions, except per share data)

(Unaudited)

 

(h) The following table presents the computations for GAAP and “Adjusted” diluted EPS, computed under the treasury stock method.

“Adjusted” EPS presented below excludes stock option expense:

 

     Three months ended
March 31, 2012
    Three months ended
March 31, 2011
 
     GAAP      “Adjusted”     GAAP      “Adjusted”  

Income (Numerator):

          

Net income for basic and diluted EPS

   $ 1,184       $ 1,287      $ 1,125       $ 1,258   
  

 

 

    

 

 

   

 

 

    

 

 

 

Shares (Denominator):

          

Weighted-average shares for basic EPS

     791         791        933         933   

Effect of dilutive securities

     9         8 (*)      8         7 (*) 
  

 

 

    

 

 

   

 

 

    

 

 

 

Weighted-average shares for diluted EPS

     800         799        941         940   
  

 

 

    

 

 

   

 

 

    

 

 

 

Diluted EPS

   $ 1.48       $ 1.61      $ 1.20       $ 1.34   
  

 

 

    

 

 

   

 

 

    

 

 

 

 

  (*) Dilutive securities used to compute “Adjusted” diluted EPS for the three months ended March 31, 2012 and 2011 were computed under the treasury stock method assuming that we do not expense stock options.

 

(i) For the three months ended March 31, 2012 and 2011, the total pre-tax expense for employee stock options was $16 million and $22 million, respectively.

“Adjusted” diluted EPS including the impact of stock option expense for the three months ended March 31, 2012 and 2011 was as follows:

     Three months ended
March  31,
 
     2012     2011  

“Adjusted” diluted EPS, excluding stock option expense

   $ 1.61      $ 1.34   

Impact of stock option expense (net of tax)

     (0.02     (0.02
  

 

 

   

 

 

 

“Adjusted” diluted EPS, including stock option expense

   $ 1.59      $ 1.32   
  

 

 

   

 

 

 

 

(j) The tax effect of the adjustments between our GAAP and “Adjusted” results takes into account the tax treatment and related tax rate(s) that apply to each adjustment in the applicable tax jurisdiction(s). Generally, this results in a tax impact at the U.S. marginal tax rate for certain adjustments, including amortization of intangible assets and non-cash interest expense associated with our convertible notes, whereas the tax impact of other adjustments, including stock option expense, depends on whether the amounts are deductible in the tax jurisdictions where the expenses are incurred or the asset is located and the applicable tax rate(s) in those jurisdictions. Due to these factors, the effective tax rates for the adjustments to our GAAP results noted in notes (a) - (f) above, for the three months ended March 31, 2012 and 2011 were 35.2% and 32.0%, respectively.


First Quarter 2012 Revenue Increased 9 Percent to $4.0 Billion and Adjusted

Earnings Per Share Increased 20 Percent to $1.61

Page 10

 

Amgen Inc.

Product Sales Detail by Product and Geographic Region

(In millions)

(Unaudited)

 

     Three months ended
March  31,
 
     2012      2011  

XGEVA® - U.S.

   $ 139       $ 42   

XGEVA® - International

     14         —     

Prolia® - U.S.

     54         17   

Prolia® - International

     34         10   

Enbrel® - U.S.

     878         821   

Enbrel® - Canada

     60         54   

Neulasta® - U.S.

     814         710   

NEUPOGEN® - U.S.

     239         220   

Neulasta® - International

     225         226   

NEUPOGEN® - International

     66         76   

Aranesp® - U.S.

     202         250   

Aranesp® - International

     316         330   

EPOGEN® - U.S.

     446         535   

Sensipar® - U.S.

     140         116   

Mimpara® - International

     79         71   

Vectibix® - U.S.

     31         30   

Vectibix® - International

     59         45   

Nplate® - U.S.

     54         37   

Nplate® - International

     36         28   

Other - International

     15         —     
  

 

 

    

 

 

 

Total product sales

   $ 3,901       $ 3,618   
  

 

 

    

 

 

 

U.S.

   $ 2,997       $ 2,778   

International

     904         840   
  

 

 

    

 

 

 

Total product sales

   $ 3,901       $ 3,618   
  

 

 

    

 

 

 


First Quarter 2012 Revenue Increased 9 Percent to $4.0 Billion and Adjusted

Earnings Per Share Increased 20 Percent to $1.61

Page 11

 

Amgen Inc.

Condensed Consolidated Balance Sheets - GAAP

(In millions)

(Unaudited)

 

     March 31,
2012
     December 31,
2011
 

Assets

     

Current assets:

     

Cash, cash equivalents and marketable securities

   $ 19,374       $ 20,641   

Trade receivables, net

     2,988         2,896   

Inventories

     2,499         2,484   

Other current assets

     1,994         1,572   
  

 

 

    

 

 

 

Total current assets

     26,855         27,593   

Property, plant and equipment, net

     5,392         5,420   

Intangible assets, net

     3,445         2,584   

Goodwill

     12,121         11,750   

Other assets

     1,437         1,524   
  

 

 

    

 

 

 

Total assets

   $ 49,250       $ 48,871   
  

 

 

    

 

 

 

Liabilities and Stockholders’ Equity

     

Current liabilities:

     

Accounts payable and accrued liabilities

   $ 5,917       $ 5,670   

Current portion of long-term debt

     2,381         84   
  

 

 

    

 

 

 

Total current liabilities

     8,298         5,754   

Long-term debt

     19,028         21,344   

Other non-current liabilities

     3,050         2,744   

Stockholders’ equity

     18,874         19,029   
  

 

 

    

 

 

 

Total liabilities and stockholders’ equity

   $ 49,250       $ 48,871   
  

 

 

    

 

 

 

Shares outstanding

     781         796   


First Quarter 2012 Revenue Increased 9 Percent to $4.0 Billion and Adjusted

Earnings Per Share Increased 20 Percent to $1.61

Page 12

 

Amgen Inc.

Reconciliation of GAAP Debt Outstanding to “Adjusted” Debt Outstanding

(In millions)

(Unaudited)

 

     GAAP      Adjustments for
accounting
standard (a)
     “Adjusted”  

March 31, 2012

   $ 21,409       $  119       $  21,528   

 

(a) To exclude the impact of bifurcating the debt and equity components of our convertible notes as required by U.S. accounting standards for these securities commencing in 2009.

Reconciliation of GAAP EPS Guidance to “Adjusted”

EPS Guidance for the Year Ending December 31, 2012

(Unaudited)

 

         2012  

GAAP EPS (diluted) guidance

     $ 5.41       -    $ 5.67   

Known adjustments to arrive at “Adjusted” earnings*:

          

Amortization of acquired intangible assets

   (a)           0.27   

Non-cash interest expense associated with our convertible notes

   (b)           0.11   

Stock option expense

   (c)     0.05       -      0.06   

Charges associated with cost savings initiatives

   (d)           0.03   

Acquisition-related expenses

   (e)           0.02   
    

 

 

 

“Adjusted” EPS (diluted) guidance

     $ 5.90       -    $ 6.15   
    

 

 

 

 

* The known adjustments are presented net of their related aggregate tax impact of approximately $0.27 per share.
(a) To exclude the ongoing, non-cash amortization of intangible assets acquired in business combinations.
(b) To exclude the non-cash interest expense associated with our convertible notes.
(c) To exclude stock option expense.
(d) To exclude charges associated with cost savings initiatives, resulting primarily from accelerating depreciation as a result of the BI transaction.
(e) To exclude acquisition-related expenses.

On April 10, 2012, we announced that we have entered into a definitive acquisition agreement to acquire KAI Pharmaceuticals. Any resulting adjustments from this transaction have not been determined. As a result, no adjustments are included in the table above.

Reconciliation of GAAP Tax Rate Guidance to “Adjusted”

Tax Rate Guidance for the Year Ending December 31, 2012

(Unaudited)

 

     2012 with PR excise tax     2012 without PR excise tax  

GAAP tax rate guidance

     11.5     -         12.6     17.2     -         18.3

Tax rate effect of known adjustments discussed above

     2.4     -         2.5     1.7     -         1.8
  

 

 

   

 

 

 

“Adjusted” tax rate guidance

     14.0     -         15.0     19.0     -         20.0
  

 

 

   

 

 

 
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