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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.