Amgen Inc. v. F. Hoffmann-LaRoche LTD et al

Filing 54

DECLARATION re #53 Memorandum in Opposition to Motion of Michael R. Gottfried in Support of Amgen Inc.'s Opposition to Defendants' Motion to Dismiss for Lack of Subject Matter Jurisdiction and Failure to State A Claim for Which Releif May be Granted by Amgen Inc.. (Attachments: #1 Exhibit 1#2 Exhibit 2#3 Exhibit 3#4 Exhibit 4#5 Exhibit 5#6 Exhibit 6#7 Exhibit 7#8 Exhibit 8#9 Exhibit 9#10 Exhibit 10#11 Exhibit 11#12 Exhibit 12#13 Exhibit 13#14 Exhibit 14#15 Exhibit 15#16 Exhibit 16#17 Exhibit 17#18 Exhibit 18#19 Exhibit 19#20 Exhibit 20 (part 1 of 2)#21 Exhibit 20 (part 2 of 2))(Gottfried, Michael)

Amgen Inc. v. F. Hoffmann-LaRoche LTD et al

Doc. 54 Att. 15

Case 1:05-cv-12237-WGY

Document 54-16

Filed 04/25/2006

Page 1 of 14

EXHIBIT 15

Dockets.Justia.com

Case 1:05-cv-12237-WGY

Document 54-16

Filed 04/25/2006

Page 2 of 14

FINAL
AMGN -Q2 2004Amgen Earnings Conference Call
Event Date/Time: Jul. 22.2004 / 5:00PM ET Event Duration: 42 min

OVERVIEW
AMGN reported 2Q04 adjusted EPS of $0.62 and GAAP adjusted EPS of $0.57. In 2Q04, AMGN submitted the BiologicaLicense Application (BLA)with the FDAforpalifermin for oral m ucositis and hematologic transplantations. In 2Q04, the Co. repurchased approx. 17m shares spending $1b to do so. Q&A Focus: Reimbu~ment, C£RA, inventory, and outlook.

@3304 ]]~omson Rnandal. Pepub]is~ed with pe'mi~ on.No pat ofthispublicalion m~ bereproduced ortraqsmitted in any form orby any means without Ihe prior w~tt~n (x)nsant of'lhomson Finand~,

Case 1:05-cv-12237-WGY

Document 54-16

Filed 04/25/2006

Page 3 of 14

I~vi(~l- ~2004/~gen Earnings O:~nferenm (~11
CORPORATE
Richard Nanula Amgen Inc. - Executive ViceR'eddent andChief FinancialCXficer George Morrow Amgen Inc.Executive VicePreddent of (3obal Commercial Operations Laura E~swas Amgen Inc-A.s~ciate Directoroflnve~orPdations Kevin S~arer Amgen Inc. - Chairman & Chief Executive Cfficer,

FINAL
Bise ~l~'l CI PANTS
~nith BameyQ'tigroup-Analyst John Sonnier Rudential EquityGoup - Analyst Eric Ende Merrill Lynch - Analyst

TRANSCRIPT

PREBfrA'nCN
Operator Good afternoon. Myname isSJsanna, and Iwill beyour conference fadlitator today. At this time, I would like to wdcome everyone to theAmgen's Sacond Quarter Financial F~$Jlts for 2004 Conference C:all. ,NI lines have b~ placed on mute to prevent any background noise. ]here will bea question and anger semon at theconcludon of thespeakers' remarks You will be allowed to a.. one question. In order to a.~ a quedion, please pre~ "~tar" then thenumber "one"on yourtdephone keypad, Towithdraw yourques~ion, please pre~"sl~' then t henumber "two" on yourtdephone ke/pad, Thank you. Ladi~ and gentlemen, I would like to introduceLaura Bi~Nas, Aseociate Director of Inve~tor Ralations Ms Big,vas, you may now begin. Laura E]iswas - Amgenlnc-As~ciate Directoroflnvedor F~ations Thank you. Good afternoon and wdcome to Arngen's second-quarter 2004 conference c~l. I'm Laura Bis~vas /L'=eociate Director of Inve~or Raiations Before westart, I'd liketo ma~e ~me cautionarydaterr~3ts W]en weestimate revenue,~ operating margins, capital expenditures, ~ and other financial metricsand discuseexpected legal, arbitration, politic~, regulatory ordinic~ resJIts, ~uch estimates and resJIts are forward-looking statements and of course, no assurance can begiven if thee~imates will beaccurate end actual results could vary materially. On this call, wemay discuss GAAP and non-GAAPfinandal metrics in accordance with ~ F~gulafion G. Youcan find a recondliation of the~ two mea,~ures on our webdte at www.amgen.com within the inved:ors saction. Pleese refer to Amgen's mos~ recent Form IO-Q report for additional information on the uncertainties and rig< factors rdated to ourbudne~ If you'venot received our preg~ retease, ples,~ call Denim Burrdl (,oh) at 805-447-3433. If you have further que~ions after the confarence call, please contact ouroffice

(£NFERBx~

~ P~IIQPAr~B

Steven Hart MorganEtanley Dean t41tter. Analyst Oraig Parker Lehman Brothers-Analyst Michael King Banc of America S~cu rities- Analyst Matt Murray AflianceCapitaI- Analyst Eric Schmidt ~cowen -Analyst Joel Sendek LazardFreres & Co. -Analyst Geoffrey Porges 8~nford Bornst ein - Analyst May Kin Ho CoIdman ~chs- Analyst I~obert Goldman BuchnghamRe..~arch - Analyst I~onald Renaud JPMorgan- Analyst Jim l~ddoch Friedman BillingsRamsey- Analyst David a~an J~r~ni~:~n As~ciates-Analyst Matt Geller O'BCl40fld Markets- Analyst Mark Augusline Oredit ,gaisee First Boston- Analy~ ~anley G~'ossman Berman Oapi~ al- Analyst

streetevents@ho mson.com

617.603.7900 www.streetevents

©20~ "]homson Rnmd~. R~publishedwith pm'nission.No pal oflhlspublication me/bereproduco:J ortnmsrnitte:l in my form orby a~y meres without the prior writtm consent oflhomson Rnald~.

Case 1:05-cv-12237-WGY

Document 54-16

Filed 04/25/2006

Page 4 of 14

FINAL
l/WIG'q- Q22004,z~gen Earrir~sO:~re~C~ll
at 805-447-1060. [his conference call is being the Arngen homepage and will bearchived for 72hours following the c.,a& Now, I would like to introduceKe~4n 8~arer, Arngen's Chairman and Chief Executive Office:. Kevin 81~arer - Amgenlnc. - Chairman& ChiefExecutiveOlficer. Thanks Laura_ Good afternoon. V~th metoday are Rchard Nanula, E~ecutive Vice Preddent and Chief Rnandal Officer and George Morrow, Executive Vice Pre~dent of Globa~ Oomrnerdal Operations 8milar to la~ quader, F~chard and I will deliver pre<oared remarks and George, asweil asRchard and Iwill beavallable forQS~ In the second quarter, our budness continued its strong performance with solid top line seJes growth inour key therapeutic areas of oncology,nephrologyand inflammation. Our s~as exhibited global strength driven bytheworldwide growth of Arane~p. V~ alse launched 1~4E~E]_ for psoria~s and Sandpar for dialyds patients suffering from secondary hyperparathyroid imq in the U.S Vkecontinue to reinvest in the budne~6 to ~upport our product~t growth in competitive markets This quarter weannounced the submi~on of a biologic license application with the FDA for F~ifermin, for ora~ mucodtis in hematologic transplant patients "fhe BLA was submitted under the FDA's fast trackde~gnation program, which isde~gned to expedite FDA review of an investigational therapy reran unmet medical need. ~thin two weeks of FDA filing, wealso filed for marketing authorization in Europe I would like to thank aJl our s~aff whose hard work and dedication made the~e filingspo~ble. Ourrecent announcement of thefailureof ourblinded 28udyof GDNFfor Parkinson'sdisease wasa disappointment for usand particularly for patients suffering from this debilitating di~. [his study was well conducted showing biological activity, but without acorresponding clinical response. W~ are committed to understanding whytheresults of this,study diffe-ed fromthe long-term improvements seen in thetwo small open label studies We've recently made avery ~gnificant commitment to start Phase 3tdals forPMG162 fromour ranked Ugand program. The start of those trials isimminent and wewill make an announcement when thefirst patient isdosed.

TRANSCRIPT

wei~i?~astsec_x~ied-quarter product selas performance was led by Aranesp, which continues to compete succesgully in the anemia market with itsless frequent dogng interval. During the second quarter, Arane~p obtained the leading market share pogtion in Europe among nephrologists and oncologists offering greater dogng convenience to patients and phy~dans V'~ alse continueto moveforward on avariaty of dinical studies with Aranesp, which we believe has strong growth potential. The proposal revimci HMA programmeT~orandum regarding thereimburmment with EPOC43q use was re~eeesd on July8 with a60-day comment period. It is expeeted that arevised policy may go intoeffent on January1, ~ or thereafter. Vke are ple~d to note that in developing the new policy, Q'vlS isfocused on maintaining the quality of patient care and responded to thenaphrology community by acknowledging that patientswith hemoglobin leve~s within t heK/DOQI target range have better outcomes and that con~derable natural variability in individual patient hemoglobin levels makes achieving these narrow targets difficult.We understand what theCMSistrying to accomplish and beiieve thecorrent draft requires only minor adjustments to ansurethat patients and providers are able to access and provide optima] anemia therapy. Neulasta continues to be the major driver of growth in the neutropenia market due to its convenient once per chemotherapy cycle do~ing. During the quarter we announced results fromthelargest growth fautorstudy ever completed, demonstrating the importance of utilizing Neulasta in first and suba~quant cycles of chemotherapy in patients on moderately myeiosuppresdve regiments 8nce phy,3dans typic~ly reserve proactive u~e of Neulasla for patients of high rig<, this study highlights the benefits of treating abroader ~t of patientswith Neulasta beginning at the first cycle of chemotherapy. ~th the recent ENBREL launch for moderate to severe psoriasis, 13-4BRR_~es exhibited avery strong pedormance. 13",lBREL'sgrowing accAotance by dermatologist sis reflected in theapproximatety 4,000 dermatologists who are currently writing ENBREL premriptions and ENBRELcontinues to have the dominant share among biologics in thismarket. In addition theS~ngpar launch fordialy~s patients suffering from secondary hypeparathyroidi sm has exceeded our expectation with over 1,930 naphrologists writing pre~Jiptions By thebeginning of Julywewere able to mcure

~ sireetevents@h~m~n0~m

1 617.603.7900

! ~ist~e~i~vents orn :i~;[:~i;.il.

L÷~~'~]

@2004 "thomson Rna~d~. F~publlshed with po'missJon.Nb pal of thispublic~tion may bereproduced or transmitted in a~y form orby my mef:r~s without the pdor written oonsent of3homson Rna3d~.

Case 1:05-cv-12237-WGY

Document 54-16

Filed 04/25/2006

Page 5 of 14

I/~t. Q~2OO4~gen ~rring~O:~fereno~QII
reimbursement withaver75°/~of thecmmerdalpayersand nearly 6% (ph) of Medicaid forSemipar. Now RIchad will review the financial pedorrnance of our products and provide additional insight into the ma-ket dynamics Richard. Richard Nanula - Amgen Inc. - Executive ViceReddent and Chief Financial Officer ]hanks Kevin. I'm plea.~d to report that adjuged earnings per share for the second quarter was 62cants per share, an increase of 2-P/0 over the same period ayear ago. TotaJ product sales also grew 27% varsus the second quarter lag yea" to 2.4billion. USproduct~es were $2 billion,an increa~ of 21% over the s~:ond quarter of lag yea and accounted for83% of total product Males International ~es were $424 million growing 63% versos the same quarter lag year. ~ sales were $633 million for the quarter, an increase of 4%, versus the same quarter lag year. ~ balieve thisincrea~.~ was dueto growth in underlying demand, partially offset bychanges in wholesaler inventory Worldwide Aranesp s~as in the s~cond quarter were $617 million, a 78% increase over the prior year. ]his ~bgantial growth was drivan bydamand inthe USand Europe. S~:ond-quader USAranesp ~es were $381 million, up 76% and international ~es were $237 million, an increa~ of 80%. Wocentinue topee market growth inthe sacond quarter, both in the USand Europe asphygcians increagngly recognize the value of tregting anemia a..'~odated with chemotherapy and chronickidneydisaase aswefl asthedosa inconveniance that Arane~p provides to their patients end practices Combined worldwide Nenlaga and NBJPOC43q ~es for the sacond quarterwere $721 million, an increase of 14%var~us the same quarter the pdor year. Worldwide Neulaga sales were the driver of this increase. Worldwide Neulaga sales reached $426 million, which included $64 million in international ~es USNeulaga Males increased 24%over the se~:~nd quarter of the prior year, reflecting an increase in demand partially offset bychangas in wholesaler inventory levals Worldwide NBJPOGEN ~as in the s~ond quarter were $295 million, an 11% decrease versusthe second quarter of theprioryear, prindpally drivan byadeclinein USdernand.

FINAL

TRANSCRIPT

ENBRB.salas were $440 million in the ~cend quarter, a45% increa~ over prior-year sales [he increase was driven by growing demand in rheumatology and dermatology, dueto agreater u~ of biologics aswe~l asthe approval of the psoriags indication. /~swe previously mentioned, webetieve that adjugad eanings provides useful ~upplernentary information to investors' however wedo recognize the importance of earningscomputed in accordance with GAAP and aswe do every quarter, we've provided a full recondliation of GN~P versus adjuged EPSinthe press reieasa weisaJed earlier todayend ispoged on ourweb~Jte Turning to some expan~ items, which I'll disousa on an adjuged bags forboth periods, cost of sales incr~sad 34% to $435 million from $324 million in the second quarter of 2003, primarily due to increa.~ed gales volumes Cost of s~es asa percentage of product s~es was gightly higher in the sacend quarter of the prior yea primarily due tocosts incurred at certaJn manufacturing fadlities which are temporarily operating at less than norrr~ capadty asthey trangtion to other products, aswefl aschanges in product mix towards higher cog products P&Dexpan~s forthe second quarterwere $460 million versJs $385 million in the ~ond quarter of 2£03, a20% increase. Tnis increase was primarily due to higher staff related expanses and higher out~ide cogs to ~pport the pipeline. 8G&Aexpens~=s forthe second quarter increased 34% to $587 million compared to $438 million in the second quader of 2003. ]his increase was prima-ily due to higher gaff related expenses and higher out,de marketing expen.~es~ which indudestheV~eth profit share related to ENBREL /~spreviougy mentioned, adjuged earnings per share was $0.62 in 2Q 2004 compared to adjusted earnings per share of $0.49 forthe same quarter in theprior year, a 27% increase. While s~es and earningsmornentum isd:rong, wedo have anumber ofggnificant expensa items that will impact the P&Lin the second half of the year. V~ expect to dosa on the Tularik acquisition, which will drive alarge increase in P&D expens.=s forthesacond half of theyear aswe add additional gaff and integrate a number of new dinicat programs #sKegn mentioned, wealso expect to spend heavily in ~upport of the large Phase 3 trials forAMG162 in the second half of t heyear and in thefourthquarter we expect to increase our $G&A expends due to normaJ ~sonal spending 617 603.7900 www,streetevents .corn

streetevents@ho mson com

@2004 "lhomson Rna~da[. Pepublishedwith permission.i',b pad of thispublic~ion may bereproduced orlraqsmitted in aly form orby a~y means withoutthe pdor wdtten (:onseqt of]horns, on Rnaqd~,

Case 1:05-cv-12237-WGY

Document 54-16

Filed 04/25/2006

Page 6 of 14

FINAL
patterns As a reealt of the~ appropriate investments, wecontinueto beliave that EPSwill bewithin the range of $2.30 to $2.40 per share for the full year on an adjusted ba~s, which will exclude any onetime items related to theTularik acquigtion. On a GN~ adjusted b~s EPSwas $0.57 in the ~cond quader, up 2-P/o versus $0.45 in 2003. Turning briefly to the balance sheet in the 9~ond quarter, werapurchased approximately 17million shares spending $1 billion to do so. We have been opportunistic and increa~ngly aggre~dve in repurcha~ng our shares Our repurcha~s in addition to reducing thedilutive effect of our employee stock optionand stock purchase plans also reflect our confidance in the long-term prospects of Amgen. ~cond-quarter cepit a~ expenditures were $356 million versus $276 million in thesecond quarter last yea-. Theincresse was principally related to our Puerto Rico manufacturing and Thousand Oaks expan~ons and thebuilding of ane~v BIBR£_ manufacturing plant in F~odeisland. Ourcash and marketable securities were $4.3 billion at theend of the~econd quarter. Before I return the call to Kevin for the Q&A, lwould like to add one more thing. Asrnany of you know, Cary Rusand<y, the head of investor relations is leaving Amgen. I would like totake thisopportunity tothank Qary for his 9x years at Amgan. He'sbeen thevoice of Amgen for many of you and wewish him well. I would als3 like to let you know we'll be announdng his raplacemant shortly. ~gnificant Operator Yes, ~r. and

TRANSCRIPT
we think

Steven Hart - MorganSlanleyDean t4ttter -Analyst I was hoping that maybe Kevin and George, you guys could layout forusobviougy without disologng your competitive po.~ition,what you guysare doing to prepare forthe changing reimbursen'~nt environment next year in oncology asthe phydciang incentives change around which drugsthat you use. (multiple speakers) -for bundling orsemething -something around that effed.

George Morrow - Amgenlnc. -E~ecutive ViceRestdent of 13obal Commerdal Operations Let metake that intwo paris Let metaik about theA.~' impact first and than I'll talk about the pridng dynamics Obviou~y, t here'sstill a lot of uncertalntiesand we don't want to pretend like we have got it all figured out but we're getting more comfortable with the.~ituation. Let me break it intotwo parts Rrst, understand there's arange of prices that will exist for Aranesp first quarterof next year. ]he high volume, high share dinics, t hey're in reallygood shape. The Iowvolume Iowshare, some potentially will bere~mburmd below cost and Ithink you'll 9~e a bifurcationof themarket. Those dinicscommitted to Proerit,those committed to Aranesp. 8~,ondly, let me just dimen~onalize the imae in terms of overall ~es If you take our second-quarter ales forArane~p, 617 million, about 2/3 of that, a little less than 2/3 are in the US If you than take the USsales and break it into non-Medicare and Medicare, 45% of gee are Medicare, 55% obviously non-Medica'e, and then if you break it down further into hospitals and clinics and again hospitals are going to be under anAWF'ba.'~ reimbursement 9/stem, clinicunderA,_':F', that'sabout a 50-50 split. ~ bottom linewe're telking about 15% of total s~es in the clinic subject to A,9:'. Particulady the ones--the ~ituations that wethink are most atri~ are patients who lack ~econdary co-pay in~uranc~ Right now ourbest estimate isabout roughly 90% of patients have sacondary co-payinsurance, leaving about 10% or about 1.5% of the patients out there that we really fest there could be an access problem. Now phygcians in dinicshave a choice. They could eat the cost becau~ they may not make monay

Kevin Sharer - Amgenlnc.- Chairman& ChiefExecutiveOlficer. ]hanks, Richard. Now we'll take your questions

Operator At this time I would like to remind know, if you would like to a~k a que~ion, prese "star", than the number one on your telephone key pad. We'll pause forjust a moment to compile the Q&A roster. Your first quegdon comes from 8cevan Harr with Morgan $[anley. Mr. Harr?

Steven Hart- Morgan~ anleyDean ~tt er -Analyst I'm sorry. Can you hear me now?.

@2004 "]homson Fina~dal. Rapublishedwith peTnis~on,l',b pat of thispublication may bereproduced ortnmsrnitted in aly form orby imy m~ns withoutthe pd or w~itten consent of'ihomson Rnmd~L

Case 1:05-cv-12237-WGY

Document 54-16

Filed 04/25/2006

Page 7 of 14

I~vl~N- Q22004 ~aen Earrings O:~fereno~ ~11
on when they don't recover the co-pay or they can send t he patients to retail or morelikely to hospital or they can decide not to treat. I think what we're hearing most isthat they're planning on s~nding the~ patients to the hospital SO, yes, it's something that we're very concerned about but I just wanted to put it in perspectiv& V'~continue towork with Q'vlS and Congrese on unintended consequences V'~do not want any cancer patients tosuffer in terms of quality of care asa result of this,and, we're going to bedoing alot of bidding on behalf of the-- patients Competitively, I think we're going tosee alevel playing fietd next yea'. You know, obviou~y, we have a broad portfolio in the oncology clinic and hospitals and aplace where advantage but 3~J is also astrong competitor there. I think the bigger iseJe iswhat happens to market growth. V'~wouldn't beserprised tosee alittle bit of a correction early on intheair asph~dans sort out their eaonomics, but we really arestill very bullish on thelong-termgrowth of the anemia and neatropenia market. On the pricing ~de, just get alittie more granular in pricing. Our pogtioning of Aranesp at launch,and e<ists today isthat we have a better product based on ourlonger dogng interval at agightly lower cost.in November of 2002, theQMScut our r¢imbursemeat in half in thehospital outpatient setting end obviou~iy this was prompted byJS.J and within days we responded with contracts that enabled usto grow our share in hospitals And we're quite plea.!ed with the results to this point. Intered:ingiy, wee<ited 2003 with arelatively stable share and price. W~were gaining alittle bit of share but ourprice ispretty stable. In February of this year, J&J rolled out their ne~v contractswith their deeger dis:ounts and once again, weresponded within days to maintain our po~ition. /ksa result, we gained ~gnificant share and you saw there~lts of that in the ~cond quarter. By the way, I hope I don't have to say once again weresponded within days Hopdully the pridngisgoing to stabilize going-forward,but t hat'sprobably not up to usnece~erily. I do want to point out that our contracts are pedormanceba.se d contracts So as the customer's volume increa~s, astheir share increa.ses, they will get a~ightiy better price and so wen theughwedon't have new contracts out there, the price could go down alittle once customers drive thegreater share and volume.

FINAL

TRANSCRIPT

Underan ~ reimbursement environment, our view isthat there'slittle or noincentive to provideincremental dis:ounts In fact,quite theoppo~te" and so hopefully wecan get back to competing on a dinica~ profileand focus on growing the market, and I think the market growth will become a bigger source of --in terms of overall component growth than just market share gains Okay? Steven Hart - Morgan~tanleyDean ~¢ttter .Analyst Okay. Tnanks, George. Operator Next question corneafromOralg Parkerwith Lehman Brothers O'aig Parker - L~hman Brothers- Analyst Good afternoon. I guess I'll a~ George a question or two and avoid the obvious question of whether you're just sort of thumbing your nose at theSreet with respect to not raigng guidance. In the psoriags setting, George, are you ~eeing people adopting thestep down do~ing, so starting patients on thedouble dose and then lowering that? Kevin S~na rer - Amgenlnc.- Chairman& ChiefExecutiveOfficer. Yes, let means~ver your first que~ion. O-aig Parker - Lehman Brothers- Analyst

c~y.
Kevin S~arer - Amgenlnc. - Chairman& ChiefExecutiveOlficer. I don't take that too well her& We're not thumbing our nose at the ~treet. ~try to provide, in RIchard's remarks, very fulsome description of why we think the guidance iswhere it is V~'re going to inves[ ~ignificently in out bugne~ in the second half of theyear. Wefe~ good about what we've done so far, and wefeei the guidance isright. ~ I must say that comment did strike me as inappropriate and I'd like to go to the next question.

Operator Next ques[ion comes from Michael K~ng with Bancof America.

~~~J Street~veni-s@ho mson,~om I 6i~i~0;.~900 ...... ~is~ reeieVent S .~m }::7:~!)i~i ©2SOt ~omson Rnandd. Rapubllshedwith pm'nis~on.Nb pm ofthispublic~ion may berep~oduoad Or transmitted Inany fon'n orby any m~s withoutthe pdorwdtten con,seat oflhomson Bna~dg.

Case 1:05-cv-12237-WGY

Document 54-16

Filed 04/25/2006

Page 8 of 14

[

FINAL

TRANSCRIPT

AVe- QZ2004.arrgen &r rings 03~ferenoe Oall Kavin Sharer - Amgenlnc. - Chairman& ChiefExecutiveOlficer.

Michael King - Bancof America 4Y~curitiea- Analyst Hi. I had aquestion about the conved. I was wondering, Richard, if you could talk about the conver~on price is$82 and change and the termination isMay '05, am l correct? I~chard Nanula - Amgen Inc.- Executive ~4ceRe~dent and Chief Financial Officer March '05.

You know, Matt, weof course, got differeqt patent expiry ,Jtuations in Europe and theUSi I don't have the exact date where the claim CI3RA ismaking in Europe, but the patent for EPOC43"4 isgoing to expire, I gue~ in December, and so I would expect CEPgk will evmtually and perhaps r~atively soon beon themarket in Europe, whether that's'05 or'05, I don't know. In terms of the US wehave got a fundamentally different gtuation in terms of thepatent ~tuation and like and asyou would expect, we're not going to be commenting here on ourpatent strategies, but I think, I would say that the market for~ familyof productsisso darn big worldwide and theprice of developing drugsthat to tryto make an assault on that market isso relatively low companies that have expertise like ROche will try. We've defended our patents before, I'm sure that CSR& won't bethe lag:, and we're confident we've got the right patent ~tate but I'm sure that eventually we'll have to probablydefend it again and we sure asheck wilt very vigorou~y, and I can just Iookto the track record we have for sume confidence forthe future. Operator Next question comes from B-ic S:hmidt with 8:3 Cowen.

Michael King - Bancof America 4~acurities- Analyst And just wondering, given the stock price where it is, have you given anythought to howyou might deal with thatwhen the maturity date comes?.

George Morrow - Amgen Inc. - Executive ViceRe.~ident of G]obal Commercial Operations Yes, Mike. hswe get dose" to that period, I thinkit will be also adeterminate of where interest rates are, aswell, the higher the intere,,t rate the, more alternatives an investor in that convertible has, but there are anumber of thingsweca~ do and you can look at some of theother LYONsthat have been out there in the marketplace to extend the LYONs beyond the put date and we're looking at that, Ithink that's a reasonably likely occurrence.

Eric Schmidt - ~Cowen - Analyst Good afternoon.Congratson thenice quarter. I really enjoyed George's answer tothe question about the changing environment forArane.~p next year. Iwas wondering if you could talk in ~imilar fashion about the £PO r~imbur~t in dialy~s?

Operator Next question cornea from Matt Murreywith AJliance Capital.

Matt Murray -/VlianceCapitaI-Analyst Yes [hank you fortaking myque~tion. Some of uswere up at the Roche premfltation today and at the bre~down on pharmaceuticals there was alive~y disousgon about CEPA I was wondering if you could review with us, isit your belief that CEPA will be available on the European market, number one?And number two, whether or not the patent issued on CSRAin the USpose any edvantege for them foreatering the USmarket? George Morrow - Amgenlnc. - Executive ViceP~e~dent of Gobal Commercial Operations Okay. Let mestart with the HM~:~. You know, wethink that CMSdid apretty good job here, First of all, they ~aid that if your h~noglobin isbetween 11 and 12, you'regoing to get better outcomes and weegree` 3hare isa natural variability that makes it difficult to get patients strictly within 11 to 12, thereforethey raise their hemoglobin tolerance to 13, which weagree with, and they a~so mention that if patients drop outof 11 and 12, dropbalow, it'smore expen.~ive to get them back in. So, let's not do anything that cauls that kind of gyration, and we agree with that.

streetevents@ho mson.com I 617.603.7900 www.streetevents.oom I:!i!i~i;~i ©2C:0~ "fhomson Rnmdal. Pepublishe::lwtth p~rnission.N3 part oflhispublicaliorlmaj berepmduced ortra~smitled Inany form orby my meres withoutthe pdor wdtten consent ofqhomson Rnmd~.

Case 1:05-cv-12237-WGY

Document 54-16

Filed 04/25/2006

Page 9 of 14

I

FINAL
Operator

TRANSCRIPT

,alVa. ~2004 ~gen E~rrings O:~rer~ Oall

]here isonepotential issue that Kevin alluded to,and that is the implementation of a policy for patients who have hemoglobins over 13end are ugng ~ higher than 40,000 amonth. V~beliave that ifthose patients are medically justified orif the do~e isbeing reduced, don't penalize those patients In fact we've met with the QMS, I think they're veq~ mindful ofthat. V~'ve got a60-day comment period and they bagcally said that CMSsintention isnot to penalize providers for doing the right thing. 83, obviou~y thed evil is in the detail. V~ need a ~mple approach. ]hey're very receptive to that and I thinkwe'll work it out.S3, we're feeling pretty good about the HMAPfv1. Turning to theacquidtion cost, right now E~XSBN by statute isreimbursed $10 per 1,000 units and we're going to an average acquidtion cost next year rdmbur~ment sy~em Bytheway, thebalance or thedifference between that price and $10 isgoing to go into the compodte rate, so very importantly providersl economics will bewhole. S) they're not taking - QMS isnot taking any money out of the system. V~'re pleased that the (]G actually did an accurate report. ]hey bagcatly reported that theaverage acquisition cost for 9~=q~l dialygs providers is950 end for large 879. S)that is accurate information that jives with our numbers V~hat they haven't told usiswhat number will theypick esthe average acquisition cost, and se, wewalt, forthem to report that.But we're pretty confident that eve-ything ismanageable for us, our customers and most importantly for patients so again, we're pretty relaxed about the.~ituation.

Next question comes from C-eaffreyPorgeswith Bear ~tearns

Geoffrey Porges- SanfordBernstein-Analyst ~1 it'sSanford Bernstein actually, but just aquickcoupleof que~ions on the pipeline. Could you give usan update on the status of Phase Ill trials and the new indications for Sanslpa- and Paifermin particularly CI4D and (~ndiscernible) on ST'all cell lung cancer and then perhaps aquick update on the Panitumumab Pha~ III recruitrnent in colorectal cancer, how that'sgoing, thanks Kevin Sharer - Amgenlnc. - Chairman& ChiefExecutiveOfficer. V~'re not going to update any pipeline guidance today beyond the AMG162. ]he pipeline daveiopment continues on pecewith what wetalked about in March. Panitumurnab, I gue~ Patifermin and solid tumor in ~slpar. George, you might comment on ~n~ipar. ~erything isproceeding at pace, isabout all wewant to say right now. Senslpar, bythe way, ishaving a re~ly strong acceptance in the marketplece, stronger than I thought, and I think it gives usa lot of optimis'n forthefutureand a lot of incentive to continueto inve~: in the caldfication of~lature in indication expanding trials Do wehave anything else on that-(multiple ~peakers)?

Operator Next question cemes from Joel Sandek with Lazard,
Joel Sendek - LazardFreres& Co. - Analyst I had a que~ion about yourcomments on inventory.Can you help usquantify the level of inventory draw-downs I guess with regard to EPOC43/and Neulasta. ~anks Unidentified Speaker ]hey were relativeiy modest but they were in the direction that I hadsald, so I-- Idon't haveany actual daysseles ]hey're within their normal ranges but they were actually slight draw-downs forthe quarter.

George Morrow - Amgenlnc. - Executive ViceReddent of dtobal commerdal Operations I think wesee anumber of drivers of growth in the future Obviously part D in2006 will bealmost a fullyfunded benefit for patientswho are -ought to be on Senslpar, weare also pur~ing primary hyperpa-athyroid is'n (243 asyou pointed out and the Europe2a launch. The onlyother thing I would say iswe're very actively involved in a Phase ill B study and it differsfrom our Pha~ III study in that in Phaselll wepretty much held vitamin D cens~ant and added on ~slpan In Phase ill-B, weactually went in with a notion of having Senslpar asa base line therapy fortreating secondary hyperparathyroid iron and then titratad in vitamin D and other the phosphate bonders and we'll be reviewing the results of that study in the nest future and our ~se is that'sgoing to be very positive in terms of minimizing the useof resourcesand also achieving a much higher percsntage

~ streetevents@ho

mson.comI 6iTi o&

g;5;51 ~:~;J~'e(,&te

©20~ ]homson Rnaqd~, Pepublished with permission.No pat ofli~tspubllcalion may bereproduceg ortra~srnitte::l in aqy form orby aqy metes withoutthe prior wdltel oons~nt of'lhomson Fina~daL

Case 1:05-cv-12237-WGY

Document 54-16

Filed 04/25/2006

Page 10 of 14

t

FINAL

TRANSCRIPT

AM(]xl- Q22004,ffrgen Brrings Gonferen~ll

getting into the K/DOQJ raqge.Ol:~era~O~e're very of patients exalted about Sen~ipar. And asKevin said, we're very plea..~d Next question comes from R3n Renaud, with ~ Morgan. with thelaunch. O1~erator Next question comes from May Kin Ho with Goldman Sachs May Kin Ho - G)ldman~chs-Analy~ Hi,George~ Can youtalk a bit about the pricing environment. You indicatad that when J&J adjusted their prices, you re~aonded within days and that they had aprice increa~ in June Was any price incresso in Juneforyou or obviously you cannot comment forthefuture? Ronald I~naud - J:Morgan-Analyst Good afternoon. Que~ion for George. George, some diseus~ons that we've had with cancer program administrator~ there'sbeen some ~eculation that McClellan rnayimplement an administrativedeiay in the~qip fromAVvP times 85% to an ~ plus 6"%. And then the length of that delay, I've heard anything, could befrom ~ix monthsto 12 rnonthsbut again, just ~peculation and I've alse heard that there may bea stay on howdrug administration ~vices are reimburs~=cl in terms of keeping this yea¢s rate the same for ne~t yea-. Curiousto know if you've heard the s~ne thing or if youcan comment at any length on that. George Morrow - Amgenlnc. . Executive £iceRe~dent of GlobaI Q)mmerdal Operations Kevin, you met with Mcaeilan --

George Morrow - Amgen Inc. - Executive ~iceReddent of Global Commerdal Operations Yes, we did rage a catalogue price i ncrea~ a couple of weeks ago for Aranesp, NBJPOGI3xl, and Neula~a at 6%

OI3erator Next question cemesfromFbbert Goldman with Buckingham

Kevin S~harer - Amgenlnc.-(]]airman& ChiefExecutiveOlficer. Yes, I just met with Dr. McC]dlan just last week, and R3n, I didn't hear anything aven remotdy like that. Our plans are that thisisgoing to get implenented on timeand we've had Iotsof disou~ons with the technicel folk at CMS and I know they're sJre thinking that, too. But, Iknow there's alot of dim_,u~ion here, Iknow alot ofphydcians are very, venj concerned and there's lots of presaJre here, but our own expectation of plansare thiswill be implemented on sehedule.

Robert Goldman - Buckinghard:;~search -Analyst ]hank you. On AMG162 and I apologize if I missed this because it sounds like you epoke to the pipeline on that product but I understood that Pha~ II data was going to be presented soon, 12month data. Can you just tell mewhen and at what forumweshould expect that data? Unidentified ~peaker I don't have off the top of my hexad theforum. What wedid announce isthat, in my ramark~ that the Phme ill trial for AMG162 has been fully funded byus which ispart of the expense at the back half of the year that we referred to, and that we think theAMG162 Phase Ill isimminent. I'm sorrywe'il have to get back to you on exactly what the~entific forum isthat thePhase II final re-:ults will bepresented butit will be thisyear.

Ol:~erator Next question comes from Jm Reddoch with Friedman Billings

Jim Roddoch - FriedmanB~71ingsRamsey- Analyst ]hank you. Just to be dear, did your previous guidance of 230 to 240 include the impact of the Tularik acqui~tion or the impact of Tularik'sP&D on yourtotal RSD, and could you just quantifywhat the per ~are impact of including Tuladk

~ st reet e~n-t s@ ho rnsd~.~m .........

~17.~0-3.790~)

©~04 Tnomson Rna~d~.F~publishedwith permiss~on.Kbpa~ oflhispublicalionma/be~produced ortraqsrnitted inanyformorby a~yrne~qswithoutthe pdor wdtten consent of]homson Rna~dal.

Case 1:05-cv-12237-WGY

Document 54-16

Filed 04/25/2006

Page 11 of 14

FINAL
Richard Nanula - Amgen Inc.- Executive ViceRe~dent and Chief Financial O'ficer Our previous guidance did not include either Tularik ora ggnificant Pha.~ Ill tria~s for 162_ 83 those are both events that have happened, gnce wegave you ourguidance late last ye~a, which iswhy they're going to impact our second haft of theyea" and be ~gnificant forus 3he -- Ican't impact on a per ~hare ba~s but I did say when weannounced the Tularik acclui~ition that weexpeeted that the Tuladk acquisition would add about $100 million annually to our R&D expanses Operator Next qu~tion cornesfrom David Chan with Jannison. David Chart - Jenni~anAsseciates-Analyst Hi. JuSt to clarify on the 2305 reimbursement. I guess there's kind of an opportunity here to flatten out your dimount Structure, sethat you wouldn't have that weird problem where the low volume oncologists would lose money. But is it just the marketplace conditions are ~Jch that you can't really do that right now? George Morrow - Amg~ Inc. - Executive ~iceRegdent of Elobal Commercial Operations David, it'sagood question, but that gets into acompetitive aea, Iwould rather not comment on now. But just recognize that under an ~ environment, any time you lower your price, you'rekind of cha~ng your tail. ~b, you know, hopefully wecan actually get it going theother way. Operator Next question comes from Matt Geller with OBC Operator

TRANSCRIPT

George Mon'ow - Amgenlnc - Executive ViceR'e.~ident of (3obal Commercial Operations I thinkit'll have a minorimpact. 3here isseme price protection in contracts, at le~t, temporarily ~me productslonger term for others But it certainly happened -- you know, this isa quarter upon which ~ for the first quarter next year will bedeterminad, se we'll have a minorimpact thisquarter, but certainly it had more impact in ~Jbmquent quarters

Operator Next question comes from Mark Augustine with CSRrst BoSton.

Mark Augustine - Q-edit~bis~First Boston-Analyst Hi. First of all,serry if I mimed it, what were the Q2 sales and do you plan to preg~qt Phase IIIB data described earlier this year? Kevin Sharer - Amgenlnc. - Chairman& ChiefExecutiveOlficer. V~didn't breakdown, I don't think Se~par s~es And the data-- we'll have to get back to you on.

Mark Augustine - QeditSJisseFirst Boston-Analyst

Kevin Sharer - Amgenlnc. -chairman& ChiefExecutiveCfficer. AgN isthelikety e~ent of nephrology meeting, I gue~, it'sin December.

Next question comes from ~tanley Grosmnan (ph) with Berman CapitA. Matt Geller - CIBCWorld Markets- Analyst Hi. 3hank you. Has the change, has price rise that you've done in June, how do youthinkthat will affect computation of AS~ going into next year or will it? Stanley Grossman - BermanCapitaI-Analyst Yes, hi.C-feat quarter. Congratulations I had&juSt a follow-up -- Bob a~kad about AMG162, the Phase II data. 3here were 500 patients and you did announce at ~ meeting that you would give afollow-up or br~kout the results within, you

streetevents@ho mson oom

617.603.7900 www.streetevents .oom

©2CO4 ]homsonRna~d~.l~publishedwith pe~mis~on,Nopat ofthispublic~tionmaybereproduced ortraq~nitted ina'~yformorby anymemswithoutlhe pdor wdtteq o3nsent of'lhomson Rnand~l.

Case 1:05-cv-12237-WGY

Document 54-16

Filed 04/25/2006

Page 12 of 14

FINAL I
~I - CI22004/~gen Earrings 0onference 0all know, the 12 months data, so there's nothing that you could comment on? George Morrow - Amgen lnc.- Executive ViceR'eddent of ~3obal Commercial Operations No. We're going to provide the data. I just don't have that date offthe top of my head. there's no untoward anything. V¢;'ll have to get back to you on the forum and the date Richard Nanula - Amgen Inc. - Executive VicePreddent and Chief Financial Officer lbe~ieve it's~ternbar, 8~attle, the American ~bciety for Boneand Mineral Re.arch. Stanley C-~ossman - BermanCapitaI-Analyst

TRANSCRIPT

at thi~ch~lrlt, lanula - Amgen Inc.- Executive ViceR'eddent and Chief Rnancial Oflicer I'll take the first one, Bise. Yes, I did reaffirm our guidance with Tularik, once again, ealier thisyear, l am reaffirming it again with Tularik asof now. I think maybe what folksare getting hung up on;we're having.a strong sales year, We were a~ready having good momentum when weannounced the Tularik deal, sowe ~d, wecould handle it in our current guidance. Now we're saying, wecan also handle 162 in a relatively ~gnificant program in ourcurrent guidance, aswe~l, so I hope that'sdarifying. George Morrow - Amgenlnc. - Executive VicePreddent of (~obal Commerdal Operations Bisa, wdve heard alot of rumors, obviously, but we've got no offidaiguidance from the QMSon when they're going to publish ~ numbers and how they're going to publish it. You know, we've heard the same ones about the phy~dan feesohedule, but nothing confirmed.

Richard Nanula - Amgen Inc. - Executive ViceReddent and Chief Financial Cfficer QK But jug forexpectations, that datawill, sort of,generally not bepad ofthee~ kind of calls R3ger isnot onthe call. "ihesa are going to be earnings and commerdal calls and we're going to usa the medic~ meetings and thingslike day to amplify further on P&D program. Operator Next que~ion cornea from Bise Wang with Smith Barney.

O£erator Next question comes from Jahn Sonnier with Prudential. John Sonnier - R'udentialEquity G'oup-Analyst V~I, thisque~tion isforGeorge. Obviously, real exalting data on Neulasta from thelow ri~k trial. And I gue~the question iswhere do you take it from here? What do you think it really takes to drivea paradigm ~qift fromreaetive to proeativeuse? Do you have some pharmaco-economi c trialssat up, I guess?. Just where do you go from here?

E]ise Wang - S-nith BameyOtigroup- Analyst Hi. Nice quarter. I was wondering two things One, if I rec~l, F~chard, I think, when you did announce the acqui~tion of Tularik, I thought you had reaffirmed your guidance at that point of 230 to 240 asindu~ive of theacquisltion? And then, second of all forGeorge, if you could perh~s share with us some of your knowledge of what's antidpated from Q V IS regarding the phy~dan fee ~heduling, what commentary they are e~pected to make about theA9~ guidOines in that? Aswe understand that physldan fee sohedule isgoing to be coming out fairly soon.

George Morrow - Amgenlnc - Executive bfceReddent of (3obal Commerdal Operations W~I, I think shsrne on usand shame on doctorsif theydon't respond to thisdata. ,~sKevin said, it'sthe largest study of its kind.lt'sunambiguous in that Neulasta dramatically reduced the incidence of febrile neutropenia, dramatically reduced the inddence of ho~itaiizati on, dramatically reduced the inddence of IVantibiotic usa and actually there was a slgna~ on lower mortality, so hopefully the data its~f, oncewe get it outthere, will ~aeak for it~f, but certainly,,bhn, thesecond part and we'll bedoing that in the near future, the second part isguidetinea and hopefully the bodies that publish

~ stre~t~venis@ho m~.cor~ .... pdor wdttm consent ofTnomson Bnmd~t.

6i~ 603.7900 I

streeteveni~ corn [.'i~i~!~1

@2(194 ]homson Rna~d 4. R~ubli~ed with p~rmiss~on.No pal ofthispublica[ion may bere#roduced or tr~smitted in any form orby my rneals without the

Case 1:05-cv-12237-WGY

Document 54-16

Filed 04/25/2006

Page 13 of 14

l

FINAL
/~1~- ~2004/~gen Earrings O3nference Call

TRANSCRIPT

g u id e~in ~ ik~,gSOan dvl,~TQ'vtNill~ic~ h o~J p and incorporate them asquickiy aspo~ble. 83 it takes time, Jahn, asyou know to change medical practice. ]~at's, you know, we're in thebu~ness of doingthat with highquality data, and thisisaphanorrena] opportunity, becauso today only about 15% of patients are being Profle< firg cycle (ph), and what this data says isa much larger percentage ought to be Proflex first cycle.

Unidentified S~eaker Once only one May 14n. You might know that there's this trend that, you know, we're going to have to cut off but for you, you can ~ a follow-up.

May I,~n Ho - Galdman 4~chs- Analyst [hank you very much. George, can you te~l uswhether the weekly preferred syringe forENBR£L would beapproved by yearend?

O~rator At thistime I would like to remind everyone, if youwould like to a~ a que~ion, please press "gar", then the number "one" on your telephone keypad. Your next question comes from Eric Ende with Merrill lynch. Eric Ende - MefrillLynch - Analyst [hanks I jug have aquick modeling quegion forF~cha-d. 13rg of a]l,tax rate was 27.3%. Isthat a number we ~hould be thinking about going forward, and then socondly on thecog of goodsor thegrossrnargin ~ould we think about thegro~ of margin going forward es~milar asto what it was in the second quarter? ~chard Nanula - Amgen Inc. - Executive ViceReddent and Chief Financial Officer COg of goods number, Eric isprobably a high water ma-k, this quarter for the yesr so the re~[ of the year ~ould bea little bit lower. And then it'sapretty reasonable number for tax rate. Operator Your next question comes from May K~n Ho with Goldman 8~chs

George Morrow - Amgenlnc - Executive ViceReddent of Gobal Commerdal Operations ]hat isour plan, yes

May I~n Ho - G31dman Sachs- Analyst R~ank you.

O£erator Next quegion comes from Biso Wang with S-nith Barney. Bise Wang - ~nith BameyC~tigroup- Analyst Do I have thesame permis§on? Unidentified Speaker Go forit. Bise Wang - ,gnith BameyOtigroup- Analyst Okay. Jug wanted to a~ you on -- you mentioned that you arepursuing obviougy theclinicat development prograrnon Arane~. Could you give usan update on the heed-to-head gudy to Procritand also any other types of gudiesthat you're conducting with Aranesp?

May I~n Ho- Coldman Sachs- Analyst Am I a~lowad to a.~ a follow up question or ~nould I go back.

Richard Nanula - Amgen Inc,- Executive ViceReddent and Chief Rnancial Q~licer Yes I'll turn this one over to George, but I would rather not have on the~ calls this dinical ~entific dis;u~on. ~e guy who runsthat is not here and isavailable at otherforums, but ~' streei~ents@ho mson.corn I - . 1 .617 6~/~900 ............... www st~eetevenis . l:::~.~:,f,!I~::!~I
©2£04 "lhomson~naqd~. F~ublishedwith pe~mis~on.Nopa't ofthispublicalionmaybe~produced ortraqsmitted ina~yformorby aqymeanswilhoutlhe pfiorwdtten consent of'ihomson Bnaqdg,

Case 1:05-cv-12237-WGY

Document 54-16

Filed 04/25/2006

Page 14 of 14

IAVe31. ~20(}4 l~n~n Earrincjs Omferenm Oall

FINAL
can take

TRANSCRIPT
this one th~

take -- we O83~M~ I think we can heed-to-head data, we've got the heed-to-heed data and I'll let Georgetalk about it. George Morrow - Amgen Inc. - E~ecutive ViceR'eddent of ~lobal Commercial Operations Yes, we've run acoupie of big trials and, you know, we feet very confidant that 20:) mice (,oh) ~ery other week is compa-able to 40,000 unitsper week of Procritand a little bit of a hint through abstracted AS30, and you know, the big trig isfinishing up pretty ~on. J&J isdoing their trial and ~o we'll be backat it in the nea futureso we're confident about that. The other trial that we're really excited about isthe treat (ph) trial. We'vetaJked about thatin thepasl. You know, right now we really see a lot of growth potentiaJ in the anemia market, and one of the thingswehave todo isget beyond the~a products being used asreplacements fortrandugons and products that treat fatigue V~ really think they're going to have apo~Jtive outcome in terms of lowering morbidity, mortality. V~'re conducting a ve-y large extremely w~l-de~gned trial that's going tolook at mortality and morbidity in particularly O<D diabetic population. And ~o that's reslly where we're going. V~'re going to continue to inv~ in growing this market, becaus~ there are lots of patients out there who are anemic and s!mptomatic who need to be treated.

09erator Ladies and gentlemen, wehave reached the and of the allotted timeforque~ionsand answers Mr.Sharer, arethere any clo~ng r~marks'? Kevin S~narer - Amgenlnc.- Chairman& ChiefExecutiveOfficer. No. ]hanks a lot. Operator t~is concludes today's conference call. You may now disconnect.

©~0~. Tnomson Rnand~. R~publi~ed with pe-mission,Nopal ofthispublicalion m~ bereproduced or tran~rnitted in any form orby my m~qs withoutthe prior wdtt~n consent of']homson Rnmd