Novartis AG (NVS) 2002 Q2 法說會逐字稿

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  • Operator

  • Good afternoon. My name is Cherette,

  • and I will be your conference facilitator today.

  • At this time I would like to welcome everyone to

  • the Chiron second quarter 2002 financial results

  • conference call. All lines have been placed on

  • mute to prevent any background noise. After the

  • speaker's remarks, there will be a question and

  • answer period. If you would like to ask a

  • question during this time, simply press star then

  • the number 1 on your telephone key pad. If you

  • would like to withdraw your question, press star

  • then the number 2 on your telephone key pad.

  • Thank you.

  • Ms. Lonergan, you may begin your conference.

  • Joyce Lonergan

  • Thanks, Operator. Good

  • afternoon. And welcome to Chiron's second quarter

  • conference call. On behalf of the Chiron team,

  • we'd like to introduce you to our principal

  • speakers today. Jim Sulat, our vice president and

  • chief financial officer, and David Smith, our

  • vice-president and finance. I'm Joyce Lonergan,

  • our vice-president, corporate development and

  • investor relations. I'll be available after the

  • call today, along with Martin Forrest and the

  • investment relations team, to answer any questions

  • you might have. Before Jim begins his discussion

  • of Chiron's results, we'd like to remind you that

  • our market today includes forward looking

  • statements related to future events and the

  • financial performance of the company. Actual

  • events in performance may differ materially

  • from our expectations. We refer you to the

  • documents that we filed with the SEC. These

  • documents include the 2001 10(k), our first

  • quarter 10(q) report and the upcoming second

  • quarter 10(q) report. All the filings include

  • information under the heading Factors That May

  • Affect Future Results [inaudible] portion of the

  • document. This information identifies important

  • factors that could cause the company's actual

  • performance to differ from our current

  • expectations, including the outcome of clinical

  • trials, regulatory review, manufacturing

  • capabilities and manufacturing and marketing

  • effectiveness. Consistent with the SEC regulation

  • SE, we do not undertake an obligation to update

  • the forward looking information that we are giving

  • you today.

  • With that, we will turn the call over to you, Jim.

  • Jim Sulat - VP and CFO

  • Thanks, Joyce. Good afternoon,

  • everybody, and welcome to Chiron's second quarter

  • earnings conference call. As you can see

  • from today's press release, Chiron had a strong

  • quarter generating high quality earnings and

  • showing solid growth in our businesses. Today

  • when reporting second quarter pro forma net income

  • from continuing operations of 29 cents per share,

  • up 38 percent from the same period last year.

  • Each of our three units performed well,

  • highlighting the value of our diverse business

  • model and stability to deliver shareholder value

  • on a consistent basis, even in a difficult market

  • environment. Chiron's second quarter results also

  • demonstrates that we are building our business by

  • investing a key product franchises. Total

  • revenues were 299 million, compared to 261 million

  • in the same period last year, an increase of

  • 15 percent. Total product sales were 211, an

  • increase of 21 percent over the same period a year

  • ago. The commercial launch of Procleix in the

  • U.S. as we said would be a major revenue driver

  • this year has gone smoothly and fully matched our

  • expectations. All U.S. customers have

  • successfully implemented conversion to in vitro

  • diagnostic products, and all contracts with our

  • customers have converted to commercial pricing.

  • We are seeing strong growth in Europe for TOBI.

  • And Betaseron continues to perform well in an

  • increasingly competitive market. All in all, our

  • operations are performing effectively and our

  • businesses have been growing at a steady rate.

  • Chiron is also building for its future through its

  • development portfolio. As you know, Chiron's

  • strategic focus is on cancer and infectious

  • disease, developing product candidates using our

  • three research platforms, small molecules,

  • proteins and vaccines. We have promising programs

  • that are advancing in oncology and infectious

  • disease across all of our business units, and

  • these programs represent significant new

  • opportunities for Chiron to grow. I want to

  • comment briefly on the performance of each of our

  • business units this quarter as well as provide you

  • with an update on certain of our development

  • programs. David Smith, who will follow me, will

  • provide more detailed financial results for our

  • commercial operations. Let me begin with our

  • BioPharma business. This business shows

  • significant growth in the second quarter.

  • Revenues, including Betaseron royalties, were

  • 21 percent higher in this quarter versus the same

  • period a year ago. TOBI sales in Europe has been

  • particularly impressive as the launch there

  • continues to gather momentum.

  • TOBI also continues to grow in the U.S. market and

  • we are seeing positive trends in product

  • penetration and utilization across all patient

  • segments. Our marketing and educational materials

  • have been key to this aimed at building awareness

  • among physicians of the advantages of chronic TOBI

  • usage for asymptomatic and mild patients and

  • improving patient compliance across all

  • severities. In the multiple sclerosis market the

  • second quarter introduction of our new room

  • temperature formulation of Betaseron significantly

  • increased sales, reflecting both the new product's

  • premium pricing and stocking by distributors.

  • Betaseron's performance is further helped by two

  • other important factors, strong clinical results

  • and M.S. market expansion as awareness of the

  • disease increases. , patient education

  • initiatives, earlier diagnosis and earlier

  • treatment. Both the evidence and income in

  • clinical trials underscore Betaseron's clinical

  • message. The higher and more frequent dosing beta

  • interferons is associated with the higher

  • percentage of M.S. patients remaining relapse

  • free. Results from these two trials were

  • presented earlier in the quarter at meetings at

  • the American Academy of Neurology in Denver and

  • the European Neurological Society in Berlin.

  • [Inaudible] common trial two-year perspective

  • randomized study concluded that high dose

  • Betaseron administered every other day is more

  • effective than Avanex [phonetic] given once a

  • week. These data were published in the April 27th

  • edition of the Lancet and are another example of

  • the multiple studies that support the value of

  • Betaseron in this market. Our partners Berlex

  • [phonetic] and Schering AG are investing with

  • Chiron in development to further differentiate

  • Betaseron. Additional studies are underway to

  • understand the value of higher and more frequent

  • dosing and early diagnosis. Beyond study, the

  • pilot phase which is scheduled to begin before the

  • end of the year will include 2,000 M.S. patients

  • and is designed to compare standard dose to double

  • dose Betaseron. Initially, the Italian M.S.

  • society which has already completed the

  • [inaudible] study will begin the optimist's study

  • to analyze the effect of higher dose Betaseron in

  • patients with inadequate response to standard

  • Interferon therapy. Lastly, the benefit trial

  • sponsored by Schering AG and started enrollment in

  • the last quarter is intended to identify the

  • effect of early treatment on new M.S. patients

  • prior to their second attack. We believe that

  • Betaseron will continue to compete effectively in

  • the M.S. market because of the product's efficacy

  • profile, a complete set of educational services

  • and patient support programs that our partner

  • Berlex has launched this year. , and future

  • product enhancements that will make

  • administration easier and faster, including a

  • prefilled [inaudible] syringe with an auto-inject

  • feature to be introduced in the U.S. next year.

  • The cancer area, sales of our leading cancer

  • product, Proleukin, were about equal to the same

  • period last year. During the second quarter

  • Proleukin celebrated its 10th anniversary as a

  • commercial product in the U.S., and in that time

  • Proleukin has become established as an effective

  • anticancer agent. We now know more about

  • immunology and the role of this molecule than ever

  • before and we're optimistic about its role in

  • immune-based therapies. Two development programs

  • are underway to build on Proleukin's value as an

  • immune system modulator and expand its potential

  • applications. Our Silcat [phonetic] trial is a

  • pivotal study designed to determine if

  • intermittent cycles of IL-2 improved clinical

  • outcomes in advanced HIV disease compared to

  • anti-retroviral therapy alone. We are also

  • examining the ability of IL-2 to expand and

  • activate TD-4 cells with the goal of enhancing

  • cellular immunity. During the second quarter the

  • cell cap Data Safety Monitoring Board reviewed the

  • one-year follow-up data on the first thousand

  • patients enrolled in the study, and we're pleased

  • to report. That the DSMB identified no safety

  • concerns with the trial and recommended that

  • enrollment proceed to 2,000 patients. We continue

  • to expect that the cell cap study will conclude

  • follow-up in 2006.

  • As part of our oncology franchise, we are also

  • conducting a program to evaluate the potential of

  • IL-2 to enhance the efficacy of Retucsin

  • [phonetic] and potentially other anticancer

  • monoclonals and development. Current data

  • suggests that monoclonals may exert their

  • anticancer activity in part by antibody dependent

  • cell mediated cytotoxicity that may be enhanced by

  • IL-2. These lung clinical results are consistent

  • with this hypothesis. Complete results of our

  • phase 1 IL-2 Retucsin studies and non-Hodgkins

  • lymphoma patients were presented [inaudible]

  • earlier this year. This program is being advanced

  • to phase 2 where Retucsin refractory patients with

  • low-grade lymphoma as well as patients with

  • high-grade lymphoma will be studied. Additional

  • phase 1 study is being undertaken at NHL patients

  • using our next generation IL-2 formulation. We're

  • looking forward to evaluating the initial results

  • from these trials next year.

  • Our oncology portfolio is balanced between

  • programs of known mechanism of action and those

  • that represent novel mechanisms. We are awaiting

  • final results of our phase 2 program for Angiozyme

  • [phonetic], and anti-agiogenic. Angiozyme is

  • being studied in colorectal cancer as combination

  • therapy with standard chemotherapy and the next

  • milestone will be reviewed as a result of this

  • study. During the quarter our partner RPI

  • terminated the breast cancer study, which did not

  • achieve a meaningful response rate as mono

  • therapy. With regard to tetrocytobene [phonetic],

  • the product we acquired as part of the matrix

  • pharmaceutical acquisition earlier this year, we

  • anticipate that our phase 2 studies in patients

  • with gastroesophageal cancer and colorectal cancer

  • will begin by the end of 2002. In the preclinical

  • area, we're bringing forward our growth factor

  • Chynase [phonetic] inhibitor for clinical

  • development. The is the first anticancer small

  • molecule development candidate from Chiron's

  • discovery program. It illustrates that we are

  • executing on our strategic focus in oncology and

  • our strong molecule capabilities are yielding

  • results. We are currently completing preclinical

  • studies, and assuming satisfactory results. , we

  • hope to file an IND in 2003. We are also seeing

  • similar progress. In our inhaled antibiotic

  • franchise. Our collaboration with Inhale

  • Therapeutics in the development of a dry powdered

  • formulation of Tobramycin, with a treatment of

  • [inaudible] infection in cystic fibrosis patients.

  • Is progressing satisfactorily. The dry powder

  • formulation is designed to enable portability and

  • reduced administration time. Phase 1 studies for

  • the dry powdered Tobramycin product are expected

  • to begin in early 2003. We are also beginning our

  • second collaboration with Inhale to develop an

  • inhalable antibiotic product based on our

  • proprietary compound PA 2794. The antibacterial

  • spectrum of this compound differs from TOBI and

  • should allow us to explore new areas of unmet

  • need. Our phase 2 study of TOBI in patients with

  • acute exacerbations of chronic bronchiectosis is

  • underway. Still some prior studies in patients

  • with stable disease which have demonstrated a

  • strong micro biological effect. The collection of

  • patients with acute exacerbations for further

  • study is expected to optimize TOBI's benefits and

  • is consistent with current practice. These lung

  • results have been published and stage 2 results

  • are being prepared for publication.

  • We now move to our vaccine business. Delta

  • vaccines were 73 million in the second quarter of

  • 2002 compared to 75 million in the same period

  • last year, a 3 percent decrease. In line with our

  • expectations Menjugate sales are lower than the

  • previous year. As we said last quarter, Menjugate

  • is a tender driven business and vaccination

  • programs have been catching up with the needs of

  • countries like the United Kingdom, Canada and

  • Ireland, where meninges disease is significant

  • concern. At the same time, however, new countries

  • are addressing this major medical need. In the

  • second quarter sales of Menjugate began in France

  • and we continue to see sales of Menjugate

  • elsewhere, including in Spain. Moreover, vaccine

  • sales other than Menjugate grew 7 percent compared

  • to the same period last year. We saw particularly

  • strong growth for our tick borne encephalitis and

  • polio vaccine. As you know, we're working to

  • expand our meningococcal franchise, and I'd like

  • to tell you a little bit about the progress.

  • We're making toward that goal. Meningococcal sero

  • types Y, C and B are the major causes of disease

  • in the U.S. and Europe, and Chiron is committed to

  • developing vaccines for these sero types. In its

  • two plus years as a commercial product, Menjugate

  • has helped to reduce death in the United Kingdom

  • due to meninges infection by more than 80 percent.

  • Chiron is building on its work with Mensee to

  • develop vaccines for the other principal

  • meningococcal sero types. Our phase 1 Men-B

  • vaccine entered testing during the first half of

  • the year. This vaccine incorporates our genomics

  • technology and is designed to be effective against

  • multiple subgroups. [Inaudible] immunogicity

  • information will be available next year. New

  • Zealand Ministry of Health selected Chiron to

  • develop a conventional strength specific Men-B

  • vaccine that is now in phase 1 testing. We're

  • also working with the Norwegian Institute of

  • Public Health to develop a Men-B vaccine effective

  • against Norwegian strains in combination with

  • Men-C. Later this year we expect to begin

  • clinical testing of a multivalent of ACYW

  • conjugate vaccine. The goal of this problem will

  • be to develop a polyvalent conjugated vaccine

  • that, unlike the current available polysaccharide

  • vaccine, induces immunological memory and is

  • suitable for pediatrics. Use.

  • Some of our early stage vaccine candidates are

  • also making progress. Chiron's HIV vaccine is

  • anticipated to be ready for phase 1 testing in

  • early 2003, and development for this vaccine has

  • been supported by the NIH. Chiron's HCV vaccine

  • is in pre-clinical development, and we're working

  • with collaborators to determine safety and

  • immunogenicity of our lead candidate. This

  • information will be useful in selecting the most

  • promising development candidates to take forward.

  • Now, with regard to our blood testing business, in

  • the second quarter we began to see the financial

  • effects of the FDA approval of Procleix in

  • February of this year. For the quarter, Procleix

  • product sales are 29 million, nearly tripling over

  • the same period last year. At the time of

  • approval we set a goal of achieving conversion to

  • commercialization within one quarter. This

  • concluded the negotiation of new contracts, the

  • transition from investigational to commercial

  • product, and the establishment of a new higher

  • level of pricing in the marketplace. Blood

  • testing group has done a superb job in working

  • with our customers to launch the product in the

  • United States, and we're also beginning to see new

  • customers in the U.S. who wish to use our approved

  • assay, leading to an increase share of the market.

  • With the U.S. conversion complete, blood testing

  • is focusing on ways to further grow its franchise.

  • The principal drivers of future growth in the

  • blood testing business will include new assay

  • developments and geographic expansion. Our ultrio

  • [phonetic] triplex assay which will add hepatitis

  • B to our existing assays or HCV and HIV, is

  • expected to begin trials in Europe late this year

  • and in the U.S. next year. HBV Assay has the

  • potential to close the window period between

  • detection lab to 20 days over currently available

  • tests. NAT is the gold standard for blood testing

  • technology and as such leading blood centers

  • worldwide are adopting the Procleix system. The

  • geographic expansion of Procleix continues well

  • with commitments received in the second quarter

  • from Belgium and Hong Kong. In Brazil we're

  • working with a partner to implement plans for roll

  • out of Procleix, major blood screening vendors.

  • NAT is also under evaluation in China, Taiwan and

  • Thailand.

  • This has necessarily been kind of a quick tour of

  • Chiron's range of activities, both from a

  • commercial and a product development perspective

  • before I turn the call over to David for review of

  • second quarter results of operations let me make a

  • couple of overall observations. I think it's

  • noteworthy that Chiron has been able to deliver

  • attractive current financial returns while

  • advancing broad development front. Progress I've

  • been describing for you represents, we believe, an

  • unusually rich opportunity that builds or business

  • in the long term. We need to continue to strike

  • the right balance between short term results and

  • long term investment, a balance that remains the

  • central part of the challenge for all companies in

  • this industry. We think our track record is good

  • in responding to that challenge and we look

  • forward to reporting to you in our progress in

  • managing us into the future.

  • Now let me turn the call over to you, David.

  • David Smith - VP Finance

  • Thanks, Jim. I'll begin with the

  • review of the results for the quarter which were

  • released today at approximately 1:00 p.m. Pacific

  • daylight time. All earnings per share amounts

  • discussed today refer to the pro forma diluted per

  • share earning. As we have discussed, we present

  • our financial results on both annals reported gap

  • basis and a pro forma basis. The adjustments we

  • made this quarter to arrive at pro forma earnings

  • consist of the amortization expense on acquired

  • identifiable intangible assets related to the

  • passage edifice acquisition and the Chiron bearing

  • acquisition. The adjustments made in the second

  • quarter of 2001 consisted of the amortization

  • expense on good will and acquired identifiable and

  • tangible assets related to the pathogenesis

  • acquisition, and discontinued operations

  • associated with the sale of our diagnostics and

  • vision businesses. For the second quarter of 2002

  • Chiron reported pro forma income from continuing

  • operations of 56 million or 29 cents per share.

  • This result was approximately 38 percent higher

  • than the earnings per share of 21 cents reported

  • in Q2, 2001. Total revenues for the second

  • quarter of 2002 increased 15 percent to

  • 299 million from 261 million for the same period

  • in 2001. Product revenues increased 21 percent to

  • 211 million from 174 million. Increases in sales

  • were seen in TOBI, Betaseron, TVE, polio and

  • Procleix. As expected, Menjugate sales were lower

  • than the second quarter of 2001. Excluding the

  • impact of Menjugate in both quarters, product

  • sales grew over 27 percent. Equity and earnings

  • was up on strong joint business profits,

  • collaborative agreement revenues decreased as

  • expected due to the Novartis funding which ceased

  • at the end of 2001. Royalty and other license

  • fees increased 11 percent, primarily due to the

  • HCV and HIV product royalties from our

  • intellectual property portfolio. Revenues

  • decreased due to the timing of contract

  • manufacturing activities and grant revenues.

  • Gross margins increased to 64 percent from last

  • year's gross margins of 63 percent. Research and

  • development expenses for the second quarter of

  • 2002 totaled 84 million, down 1 percent from the

  • second quarter of 2001. There was a decrease in

  • research and development expenses due to TIP-V

  • [phonetic], as the trial concluded in the fourth

  • quarter of 2001. This was offset by increases for

  • the development of TOBI, Hexosidobene [phonetic],

  • our monoclonal antibody strategy, and our

  • meningococcal franchise. SG and A expenses for second

  • quarter 2002 totaled 71 million as compared to

  • 61 million in the second quarter of 2001.

  • Increased SG and A expenses are due to our continued

  • investment in and defense of our patents and

  • technology, support for the market penetration of

  • TOBI in Europe as well as the commercialization of

  • Procleix. Our estimated full year effective tax

  • rate is 27 percent as we communicate in the last

  • quarter's call, the tax rate decrease which was

  • expected reflects the implementation of several

  • tax planning strategies late last year. Now I'd

  • like to move on to a review of business unit

  • financial results starting with our

  • biopharmaceuticals unit.

  • Total biopharmaceuticals, product revenues

  • including Betaseron royalties were 115 million in

  • the second quarter of 2002 up from 95 million over

  • the year ago quarter, a 21 percent increase. This

  • increase was primarily driven by TOBI and

  • Betaseron sales. Our second quarter TOBI sales

  • were 34 million, up 44 percent from the year ago

  • period due to the increased patient demand and

  • compliance in the U.S. price increases, and a

  • progress of the TOBI launch across E markets in

  • Europe including Germany, Spain and France.

  • Second quarter sales of Betaseron including the

  • royalty earned from the sale of Betaseron by

  • Schering in Europe were 45 million versus

  • 37 million last year, an increase of 22 percent.

  • In the second quarter of 2002 we experienced some

  • stocking by distributors fall room temperature

  • formulation. Second quarter sales of pro luke an

  • were 28 million comparable with the year ago

  • period. Gross margins in the biopharmaceutical

  • segment increased from 72 percent from last year's

  • gross margins of 68 percent. This increase was

  • primarily product sales and pricing increases

  • taken in the first quarter. Now turning to

  • vaccines, the second quarter of 2002 total product

  • revenues for the vaccines business were 73 million

  • versus 75 million in the same period last year.

  • We recognize 10 million of Menjugate sales this

  • quarter compared to 16 million in the second

  • quarter of 2001. However, it's also important to

  • note the growth in the rest of our vaccines

  • portfolio with sales up 7 percent year over year.

  • EPE did well in Germany not for profit agencies

  • and developing markets such as India. Gross

  • profit for vaccines was 61 percent, down from the

  • 65 percent reported in the second quarter of 2001.

  • This was a result of a additional product reserves

  • in the second quarter of 2002 due to various

  • issues, including seasonality patterns, excess and

  • obsolete inventory and production yields. In

  • addition, last year's gross margin represented the

  • benefit of the heavily weighted average of

  • Menjugate's higher gross margin in the product

  • mix.

  • Moving on to blood testing, blood testing total

  • revenues including product sales in the joint

  • business, collaborative agreement revenues, and

  • royalty and license fees increased to 77 million

  • in the second quarter of 2002 from 43 million in

  • the year ago period, a 79 percent increase. This

  • increase was primarily due to the higher product

  • sales of Procleix over a year ago as well as the

  • royalty revenue for the use of HCV and HIV

  • intellectual product and blood screening. Product

  • revenues recognized in the second quarter of 2002

  • include the commencement of commercial pricing in

  • the U.S. for Procleix and continue penetration

  • into several markets abroad. Procleix will

  • continue to drive substantial growth in this

  • business unit.

  • Now in summary, let me take a moment to highlight

  • our view of the second quarter and some key events

  • that took place. Product sales were up over the

  • prior year. Procleix made the move to commercial

  • pricing during the quarter or we're pleased with

  • the progress made since approval and awarded the

  • contribution for this important product over the

  • second half of this year. TOBI also showed good

  • growth over the prior year with the roll out

  • from Europe and increased demand in the United

  • States. Operating expenses continue to be a focus

  • point, but we are not holding back in

  • opportunities to invest in the business we are

  • please with the growth and operating income of the

  • prior year and Q1 of this year. All businesses

  • contributed growth this quarter. The delivery of

  • these results is indicative of substantive nature

  • ask diversity of our business model. Our

  • previously issued guidance of earnings per share

  • between the dollar ten and dollar 20 remains

  • unchanged. Our performance in Q2 gives us the

  • continued confidence that we will hit this goal.

  • As we have noted in the past, we expect the second

  • half to be higher in earnings per share than the

  • first. 2002's milestones are significant and we

  • are focused on meeting them. From our affirmed

  • earnings per share guidance to our goal of ten

  • clinical advances we will continue to challenge

  • ourselves and leverage the advantages of our

  • business month model. All this is consistent with

  • our focus on long term growth and increasing

  • shareholder value.

  • I'd like to turn call back to Joyce now.

  • Joyce Lonergan

  • Thanks, David. That concludes

  • our prepared remark. Now we'd like to open up the

  • call for questions. As we do so, we're joined by

  • Bill Green, our senior vice president, general

  • counsel and president of Chiron blood testing, and

  • Bruce Scharswitt [phonetic], who is our

  • vice-president of clinical development. These

  • folks will provide assistance to us during the Q

  • and A, and as always, Martin Forrest and the

  • investor relations team and I will be available

  • after the call to address any further questions

  • you might have.

  • With that, Operator, let's open the call for 00:28:36 questions, please.

  • Operator

  • Okay. And at this time if you do

  • have a question, please press star and the number

  • 1 on your telephone key pad. We'll pause for just

  • a moment to compile the Q and A roster.

  • [Pause.]

  • Your first question comes from Eric Smith of SG

  • Cowen.

  • Analyst

  • Good afternoon, everyone. I was

  • wondering if you could tell us a little bit more

  • about Menjugate whether you got any tender orders

  • in the quarter from France perhaps, and what the

  • backlog did in Q2?

  • New Speaker

  • There were no major new tenders

  • received in the period, Eric. Our backlog coming

  • out of the end much Q2 is about $22 million.

  • Analyst

  • So you still expect sales in '02 to be

  • half of what they were last year, Jim?

  • New Speaker

  • That's still our expectation,

  • Eric.

  • Analyst

  • And then on NAT testing, Procleixs,

  • you mentioned you completed now the conversion to

  • commercial pricing of the. Just as far as helping

  • us model the remainder of the year, did that

  • happen earlier in the quarter or later in the

  • quarter, and what should we expect? I guess a

  • significant jump up in Q3 as you get the full

  • quarter benefit but not more growth in Q4?

  • New Speaker

  • Eric, I'm going to let Bill Green

  • take that one because he's probably the best

  • person to respond to it.

  • New Speaker

  • Thanks, Jim and Eric, for the

  • question. We believe that the U.S. market is

  • going to continue to grow for us over the next

  • several quarters. As we expand both customer base

  • and which is going on, interestingly, and as we

  • realize the effect of full commercial pricing for

  • the full period. We did not achieve the full

  • commercial pricing at the beginning of the second

  • quarter, but we did do it during the second

  • quarter as we had expected, and therefore the

  • second quarter as Jim had indicated did not

  • reflect full commercial pricing in the U.S. third

  • quarter will. Fourth quarter should see some

  • growth beyond that.

  • Analyst

  • Great. Thanks a lot.

  • New Speaker

  • No problem.

  • Operator

  • Your next question comes from Dennis

  • Harp of Deutsche Banc.

  • New Speaker

  • Hi, Dennis.

  • Analyst

  • Thanks for taking questions, and

  • congratulations on a very strong second quarter.

  • New Speaker

  • Thanks.

  • Analyst

  • First on Betaseron, how much do you

  • anticipate was inventory stocking in the second

  • quarter?

  • New Speaker

  • This is David. You have to

  • remember a couple of things that go on with beta.

  • Rolex made the ships to wholesaler distribution

  • network as you recall was foreshadowed a quarter

  • or two ago. And we also said last quarter that

  • shipments for beta from us to Rolex were somewhat

  • artificially low due to the fact that we were

  • gearing up for the room temperature formulation

  • for beta. So there's been some stocking that's

  • out there, but we view it as more prep for a new

  • product introduction at this point. To be fair,

  • there's noise out there right now for beta with

  • the Reba [phonetic] launch, but it's going to take

  • a couple quarters to kind of shake that all out.

  • New Speaker

  • As near as we can tell if we try

  • to filter out all of the changes that we're still

  • comfortable with the guidance given by our partner

  • for Schering low to middle double digit growth

  • this year, but there is as David reiterates, a lot

  • of changes going on and as a result the numbers

  • are a little hard to interpret in any given

  • quarter.

  • Analyst

  • Okay. Then on blood testing, Bill,

  • you mentioned that we should expect growth even in

  • the fourth quarter. Where does that growth come

  • from?

  • New Speaker

  • The growth in the United States,

  • while it comes from U.S. growth in customer base,

  • we're continuing to get inquiries from former and

  • current Roche customers to expand our market

  • share. Current market share in the U.S. is about

  • 75 percent. We are pleased to say the first Roche

  • customer, former Roche customer to convert to the

  • Procleix system went effective the beginning of

  • this month. We expect to have additional market

  • share through the end of the year, and some

  • additional transitional price adjustments to ore

  • can you remember in the third and fourth quarter.

  • Main increases in revenues and earnings, beyond

  • the U.S. market of course, is international

  • expansion where I think we're proceeding well with

  • our roll out both in Europe and in the Far East.

  • Jim highlighted some of the countries where we've

  • got serious evaluations underway. We've got

  • customer contacts in many geographies. Overall,

  • the -

  • [Lost connection at 4:47 p.m. and was reconnected

  • at 4:49 p.m.]

  • Analyst

  • Okay. And one final question, and

  • that is on manufacturing for the flu vaccine for

  • this season. Do you have a good handle on what

  • your yields are and whether you will be fortunate

  • enough to be one of the first suppliers out there

  • in order to achieve your sales target?

  • New Speaker

  • Dennis, this is Jim. I think

  • we're comfortable in terms of our yields with the

  • product. That's to be fair, consistent with what

  • we've been saying the last couple of months. I do

  • not know the answer to your second question which

  • is whether or not we expect to be the first in the

  • market. We don't see any major problems in terms

  • of our manufacturing cycles, but at least the

  • scuttlebutt in the industry were that other people

  • were also having comparable success in

  • manufacturing the product. So whether or not

  • we're going to beat other people at this point in

  • time, we simply don't know.

  • Analyst

  • Okay. Great. Thank you.

  • Operator

  • Your next question comes from Eric

  • Ginsberg of Piper Jeffrey.

  • New Speaker

  • Hi, Peter.

  • Analyst

  • Yes, good afternoon. Hi. First on

  • the blood testing side, would you say that the

  • average U.S. NAT customer switched to the new

  • pricing level early, mid or late in the quarter?

  • New Speaker

  • They generally switched in the

  • middle of the quarter.

  • Analyst

  • Okay. That's helpful. Thank you.

  • The joint business revenue was up I think higher

  • than it's been in a quarter for a long time. Any

  • reasons for that, with J and J?

  • New Speaker

  • Well, the joint business is doing

  • well. Partly that's a question of difficulties

  • with Abbott. But overall the joint business

  • activity has been strong. There were some

  • adjustments in the receipts that we got from or

  • though this year - this quarter and therefore I

  • don't think you can regard this quarter as being a

  • steady run rate period. But we're pleased overall

  • and the long term issue for you is the

  • attractiveness of that business which still

  • remains strong.

  • Analyst

  • Next question, switching to drugs we

  • haven't talked about in a while, FGF, we saw an

  • article recently in the Lancet that actually

  • showed some quite encouraging phase 2 data,

  • appeared to us, regarding FGF, and then in a

  • publication this week the folks at sigh owes had

  • mentioned Chiron was considering a phase three

  • trial of that agent. Can you give us an update on

  • that program?

  • New Speaker

  • Sure. Handle that one, Peter.

  • Analyst

  • Thanks.

  • New Speaker

  • Actually, the complete results of

  • the phase 2 have not been publish. The results of

  • the AD study were published in Lancet as you

  • mentioned with an accompanying editorial. We

  • thought a lot about this program, and it currently

  • falls outside of our focus areas, cancer and

  • infectious disease. Therefore, we don't plan to

  • do further development ourselves, but are looking

  • at alternative business strategies to monotize

  • [phonetic] this asset.

  • Analyst

  • Thank you very much.

  • Operator

  • Next question comes from Philip Cross

  • of Adeg Capital.

  • Analyst

  • It's Adage Capital [phonetic]. Most

  • of the questions on NAT have been answered. Can

  • you remind us again what the profit model is of

  • this product in terms of revenue sharing with the

  • partners both on the Roche royalties as well as

  • the product you market yourselves in terms of how

  • it's shared and what kind of operating margin

  • folks are talking about in the business as it

  • comes into the Chiron P and L?

  • New Speaker

  • Sure. First on the jump rope

  • relationship, we pay Jim crow a fixed percentage

  • of revenues for their contribution, their

  • contribution includes the manufacture of all the

  • assays and the revision to us of the instrument

  • system. The way of looking at that is our cost of

  • good goods is the amount we pay to Gen-Probes

  • which the fixed percentage of revenues in the 40s.

  • And therefore our gross margin on that business is

  • the conversion of that, a number that is in the

  • mid 50s percent of revenues. The Roche royalties

  • are very attractive. We have not published the

  • royalty numbers, although that information has

  • circulated out in some geographies. It's a number

  • which we had intended to make ourselves, not

  • entirely neutral on who sells the product, but to

  • be close enough that we were willing to gauge our

  • overall success in achieving this market

  • opportunity based upon the rate at which we and

  • Roche together penetrated new available market.

  • Analyst

  • So the Roche royalties are shared with

  • Gen-Probe.

  • New Speaker

  • They are not.

  • Analyst

  • They are not. But when you say that

  • they're similar to your own participation in the

  • manufacture product, that's to say net of the

  • Gen-Probe cost of goods?

  • New Speaker

  • Gen-Probe cost of goods and our

  • own operating costs.

  • Analyst

  • Your own as well. Your operating cost

  • are they largely fixed from the standpoint of

  • thinking about the incremental revenues coming in

  • as this business grows?

  • New Speaker

  • The biggest fraction of them

  • probably are fixed, but there is a very large

  • product support and technical support component

  • that probably has to be measured incrementally.

  • Analyst

  • Okay. The second question is on

  • Betaseron. If your revenue number is right and

  • then in the release you talked about the actual

  • revenues that came from Berlex [phonetic] as well,

  • it sounds like the direct marketing of beta serum

  • was up about a million dollar in terms of

  • nonroyalty business. Am I reading that correctly

  • in terms of that being sort of the U.S. sales

  • growth? Is it sort of flat? [inaudible] the

  • release Berlex laboratory marketing and resale 27

  • versus 34 and you gave us a total of 45 versus 37

  • which implies that the non-Berlex portion is the

  • difference there. Am I reading these numbers

  • incorrectly?

  • New Speaker

  • I'll pull it out of the press

  • release. I can take a look at it for myself but

  • it doesn't make any sense based on what you told

  • us. Sales and products 34 versus 27, those are

  • correct numbers. And what else were you looking

  • at, Phil?

  • Analyst

  • I thought you gave us 45 million

  • versus 47 as the total Betaseron franchise

  • revenues.

  • New Speaker

  • Including royalties.

  • Analyst

  • In your conversation, did I mishear

  • that?

  • New Speaker

  • That's correct.

  • New Speaker

  • We were including in that

  • conversation was the royalties we received for the

  • product sales outside the United States.

  • Analyst

  • I see. So the royalties are what went

  • up, would be the difference only, and the product

  • sales are 27 versus 34?

  • New Speaker

  • Actually the royalties were

  • relatively consistent year over year.

  • Analyst

  • Okay. Okay. Got it. Okay. Great.

  • Thank you.

  • New Speaker

  • No problem.

  • Operator

  • Once again, I would like to remind

  • everyone, if you would like to ask any questions,

  • please press star, then the number 1 on your

  • telephone.

  • Your next question comes from [inaudible] of

  • Goldman Sachs.

  • Analyst

  • Hi. Most of my questions have been

  • answered. Just two more. One is on conjugate.

  • What is the backlog that you have? And the second

  • is how much of this spares you on sales were due

  • to stocking?

  • New Speaker

  • I think you mean Menjugate in your

  • first question, May Kim; is that correct?

  • Unknown Speaker

  • NEW SPEAKER:

  • Analyst

  • Yes.

  • New Speaker

  • With regard to Menjugate as I

  • mentioned before the backlog is 22 million at the

  • end of the quart ore.

  • Analyst

  • Sorry I didn't get that.

  • New Speaker

  • No problem. And with regards to

  • the Betaseron sales, I think David and I tried to

  • answer before, stocking is not insignificant part

  • of the sales increase this quarter, certainly not

  • all of it, but there are so many changes going on

  • in this channel right now, that the fair

  • [inaudible] difficult for us to estimate that

  • number with certainty.

  • Analyst

  • But is it more than 5 million?

  • New Speaker

  • I think I probably stand by my

  • initial comment. I mean I wish I could do better

  • for you with that May Kim but the change in the

  • distribution pattern we sort of have two level

  • distribution structures that we have to measure

  • and it's more difficult.

  • Analyst

  • And what are you seeing on the trends

  • for M.S. in Europe? Are you seeing an impact on

  • Paxil?

  • New Speaker

  • Paxil is certainly taking market

  • share in Europe, but I don't think there has been

  • any major change in the latest quarter on that.

  • Analyst

  • Okay. Thank you.

  • Operator

  • Your next question comes

  • from [inaudible] of UBS Warburg.

  • Analyst

  • Hi. In terms of the NAT business, I

  • was wondering in terms of the revenue ramp when

  • you're talking about contracts with the blood

  • banks, obviously what was the revenue ramp since

  • you received approval? That is, what proportion

  • of contract immediately goes back - go up to

  • market value or if they don't what sort of the

  • progression of price increase or revenue increase

  • from those contracts?

  • New Speaker

  • Well, Merrill, we're trying to I

  • guess deconvolute the second quarter number here

  • in order to get a U.S. run rate on [inaudible] and

  • I don't think I can get you any closer than we've

  • gotten so far. We've managed to convert the whole

  • U.S. market to a commercial pricing in the second

  • quarter. Some customers came aboard at different

  • times in that period and we've not really

  • deconvoluted that. We do expect there to be

  • continued growth in the third and fourth quarters

  • and we'll see the full effect of the commercial

  • pricing in the third quarter numbers.

  • Analyst

  • Thank you.

  • New Speaker

  • No problem.

  • Operator

  • At this time there are no further

  • questions.

  • New Speaker

  • Okay. Let's cut it off at that

  • point, Operator, and let me see if I can make just

  • a couple of closing remarks.

  • As I said at the beginning, Chiron has delivered

  • high quality earnings in the second quarter which

  • we believe underscores the value of the business

  • model we're pursuing. So a strong total revenue

  • and strong product sales growth while at the same

  • time we made good progress when building our

  • portfolio for the long term. Just a couple of

  • highlights. One is the product sales grew

  • substantially, increasing 21 percent over the same

  • period last year. Margins were excellent. Gross

  • margin operating margin, net income margin all

  • were above last year's levels. And in the product

  • area, as we've been discussing, Procleix made a

  • smooth transition to commercialization over the

  • quarter, but now all of our customers are paying

  • commercial prices and we continue to expect

  • Procleix to be a major driver of our revenue

  • growth in the second half of 2000 and beyond. All

  • of these factors point to Chiron's ability to

  • continue to deliver shareholder value while

  • building a strong pharmaceutical company and

  • generating steady profits. We're confident about

  • Chiron's performance and outlook. And I want to

  • take this moment to thank all of our shareholders

  • and thank all of you to take the time to

  • participate in our call today. Take care.

  • Operator

  • Thank you for participating in 00:46:57 today's conference call. You may now disconnect.