. Richard Clark, Merck & Co., Inc., CEO, President
. Graeme Bell, Merck & Co., Inc., Senior Director - IR
. Peter Kellogg, Merck & Co., Inc., EVP, CFO
. Barbara Ryan, Deutsche Bank, Analyst
. John Boris, Bear Stearns, Analyst
. Jami Rubin, Morgan Stanley, Analyst
. Tony Butler, Lehman Brothers, Analyst
. Tim Anderson, Sanford Bernstein, Analyst
. Harlan Sonderling, Columbia Mangement, Analyst
. James Kelly, Goldman Sachs, Analyst
. Roopesh Patel, UBS, Analyst
. David Risinger, Merrill Lynch, Analyst
. Chris Schott, Banc of America, Analyst
. Seamus Fernandez, Leerink Swann, Analyst
. Bruce Kuhlik, Merck & Co., Inc., General Counsel
MRK reported full-year 2007 revenue of $24.2b and 4Q07 revenue of
$6.2b. Full-year 2007 net income was $3.3b and GAAP EPS was $1.49.
4Q07 GAAP net loss was $1.6b or $0.75 loss per share. Co. expects
2008 GAAP EPS to be $3.80-4.00 and non-GAAP EPS to be $3.28-3.38.
A. Key Data From Call
1. Full-year 2007 revenue = $24.2b.
2. 4Q07 revenue = $6.2b.
3. Full-year 2007 net income = $3.3b.
4. 4Q07 GAAP net loss = $1.6b.
5. Full-year 2007 GAAP EPS = $1.49.
6. 4Q07 GAAP loss per share = $0.75.
7. Full-year 2007 non-GAAP EPS was $3.20.
8. 4Q07 non-GAAP EPS was $0.80.
9. 2008 GAAP EPS guidance = $3.80-4.00.
10. Full-year 2008 non-GAAP EPS guidance = $3.28-3.38.
S1. Business Review (D.C.)
1. Momentum Co. has gained through its consistent performance
over the prior [several] quarters is seen in its strong qtr.
and overall annual results.
1. Delivered those results notwithstanding an uncertain
short-term economic outlook and the impact of major patent
2. Continued focus on Co.'s plan to win will enable to:
1. Accomplish business goals.
2. Address emerging challenges.
3. Discover and develop breakthrough medicines and vaccines.
1. 4Q07 revenue was $6.2b, topline growth of plus 3% vs. 4Q06.
2. Full-year 2007 revenue was $24.2b, plus 7% higher than 2006.
3. Based on a continued market penetration and global rollouts of
new product introductions over the past two years, including:
4. Co. is on track to sustain growth in 2008 and deliver
long-term double-digit EPS growth from 2005-2010, excluding
5. During 2008, Co. will continue to assertively launch new
1. Ensure that as many patients is possible worldwide have
access to Co.'s innovated and needed medicines and vaccines.
6. Most established products continued to deliver strong
7. Taking together these established franchises along with Co.'s
new first and class vaccines and medicines.
1. Gives Co. a diverse product portfolio that has well
positioned it to drive revenue growth through 2010.
8. Full-year 2007, non-GAAP EPS was $3.20, which excludes 4Q07
charges related to:
1. US VIOXX Settlement Agreement and civil governmental
2. Restructuring charges and insurance arbitration gain.
1. Full-year GAAP EPS was $1.49.
9. 4Q07 non-GAAP EPS was $0.80, excluding previously disclosed
10. On a GAAP basis, Co. had $0.75 loss per share.
3. Next Generation Products:
1. Pleased to report with the most recent approval of EMEND for
1. Achieved eight approvals in 24 months.
2. Benefit of new business model as it relates to the
regulatory filing process.
1. First full-year on the market was an exceptional $1.5b in
2. 4Q07 sales were $339m.
3. To date, distributed more than 20m doses of vaccine worldwide,
since its market launch just a year-and-a-half ago in June
4. GARDASIL has been approved in 93 countries and is being ready
for launch in 76 of those countries.
5. JANUVIA and JANUMET:
1. Global revenue reached nearly $300m in 4Q07.
1. Reflecting the high value that physicians, patients, and
payers are placing on Co.'s products and on healthcare
benefits they provide.
2. Also demonstrate that Co. continues to build on momentum
established with product launches last year.
2. JANUVIA has already become second leading branded oral
anti-diabetic agent in US, in terms of new prescription
3. Going into 2008, JANUVIA has achieved second tier
reimbursement coverage in more than 200m lives across managed
care commercial (indiscernible) in US.
1. Ex-US, it is available in more than 65 countries including
the recent approval in Canada.
4. In European Union, JANUVIA already has received full
reimbursement in 14 countries.
1. Introduction of ISENTRESS is a realization of Co.'s 20-year
commitment to HIV AIDS.
2. Co. is working hard to build on the successful launch of
ISENTRESS, to ensure that it reaches its full market
3. Co. will continue to work closely with all stakeholders to
faster patient access to ISENTRESS.
1. To assist patients in need, Co. has established a support
program in US.
4. This has been another outstanding qtr. for Co., as its new
products established their leadership in an increasing
competitive market even as old products have got on patent.
7. Other Details
1. Co.'s success is helping it to invest in its future, as it
continues to fully fund research spending on:
1. Investigational product development.
2. Acquisition of NovaCardia.
3. More than 50 new licensing opportunities in therapeutic
areas that are strategic importance to Co.
2. Overall financial results were also supported by strong
performances of partnership and alliances.
1. Merck/Schering-Plough partnership in 2007 continued to drive
8. Enhance Job:
1. Co. stands behind safety and efficacy profiles of ZETIA and
2. Acted with integrity and good faith in connection with
3. Enhanced was not powered or designed to assess cardiovascular
clinical event outcomes.
1. Co. has a large clinical outcomes trial underway called
2. IMPROVE IT trial is intended to measure clinical event dates
in more than 10,000 patients with acute coronary syndrome.
3. IMPROVE IT is examining VYTORIN simvastatin 10/40 vs.
1. Relationship between LDL lowering and overall reduction in
cardiovascular morbidity and mortality in this patient
4. VYTORIN significantly lowered LDL cholesterol vs. simvastatin
1. As FDA noted last week in a news conference, elevated LDL
cholesterol is very well established risk factor for heart
2. These important findings are also reflected in The National
Cholesterol Educational Panel guidelines that continue to
identify LDL cholesterol as a primary target for lipid
1. Recommended lower target goal levels for LDL over time.
5. Clinical studies, which are included in VYTORIN's prescription
information, have demonstrated:
1. VYTORIN lowers patient's LDL cholesterol more than
atorvastatin or simvastatin at the doses studied.
2. Many patients with elevated cholesterol cannot achieve their
cholesterol treatment goals with diet and exercise.
3. Many of those patients also cannot achieve their treatment
goals with statins alone.
4. Plans to discuss enhanced data in a proper scientific
context at the American College of Cardiology meeting in
9. 2008 Outlook:
1. For 2008, continues to anticipate that many of its in-line and
newer franchises will maintain their strong performance.
1. Looks forward to launching additional new products such as
CORDAPTIVE if approved.
2. Anticipates that worldwide revenue will be driven by
additional indications for Co.'s products.
1. Continued marketing up-take and global rollout of new
products and other potential new introductions.
3. When taken together, all of this should help Co. to offset the
upcoming loss of marketing exclusivity for FOSAMAX, second
largest product in US.
4. During 2008, plans to file two NDAs for products currently in
Phase III, mainly MK-0524B for atherosclerosis and MK-0364 for
5. On EPS, Co. is confident in its ability to execute against
1. Reaffirmed full-year 2008 non-GAAP EPS of $3.28-3.38,
excluding certain items.
6. Made a slight revision to 2008 GAAP EPS, which now anticipates
to be $3.80-4.00.
1. Implemented the new research model.
2. Made significant progress towards creating standard global
processes for late stage clinical development.
3. New global human health organization is in place representing
a significant change from the way Co. has operated in the
1. Beginning to make in-roads towards a new customer-centric
commercial model in US and other key markets around the
11. Global Franchises:
1. Has introduced new stage gates to help Co. fine tune the focus
of research activities on the highest value areas in terms of
customer need and probabilities of success.
1. Manufacturing division and Co.'s supply strategy have led
the way in returning it to Pre-ZOCOR patent expiry PGM, a
year earlier than anticipated.
2. Establishing lease supply chains.
3. Leveraging low costs and external manufacturing.
4. Consolidating manufacturing plant network.
2. Remains confident that current products and anticipated new
product introductions and cost savings initiatives will help
Co. to position it to deliver what it promised in Dec. 2005.
1. To generate revenue growth of 4-6% on a compound annualized
basis from 2005-2010, including 50% of revenue from JV from
which Co. derives equity income.
3. By sustaining cost management initiative, expects to fulfill
Co.'s promise to expand the product portfolio, while
maintaining marketing and administrative expense flat in 2010
relative to 2006 base.
1. Continues to expect compound annual double-digit earnings
growth excluding restructuring charges and one-time items by
2010 from a 2005 base.
S2. Financial Review (P.K.)
1. Throughout 2007, in-line product portfolio and newly launched
pharmaceutical products and vaccines helped to drive strong
organic growth, overcoming the impact of ZOCOR and PROSCAR
2. Continues to significantly reengineer business to ensure that
Co. has a sustainable operating model, that can weather the
upcoming loss of marketing exclusivity for FOSAMAX.
1. These successes have allowed Co. in 2007 to deliver 10%
revenue growth including 50% of JV and 27% non-GAAP EPS
growth, despite patent expires that exceeded $2b.
3. Continues to make necessary pipeline investments internally
and externally to position Co. for long-term success.
4. For 2008, remains on track and Co. reaffirmed non-GAAP EPS
guidance and guidance elements for the operating line that
5. Related to GAAP guidance:
1. Increasing restructuring guidance for 2008, as Co. continues
to drive efficiencies.
2. Lowering estimate for the minimum gain associated with AVLP
restructuring in 2008, based on new information that has
come in and update the calculation for the minimum gain.
6. 4Q07 non-GAAP EPS growth excluding restructuring costs and
certain items was driven by several lines in P&L all with
7. Revenue line grew 3%, reflecting:
1. Strong performance of new vaccines in VARIVAX.
2. Continued market leadership for Cingular.
3. Newly launched pharmaceutical products including:
8. Product GM line showed continued strength, due to:
1. Sustained operational efficiencies.
2. Favorable mix.
9. Benefited in 4Q07 on the tax line.
1. In 4Q07, total revenue was $6.2b, 3% increase over 4Q06.
1. 1% decline in volume.
2. 4% increase from FX.
3. 1-point increase from price.
2. On a full year basis for 2007, total revenue was $24.2b, 7%
increase over 2006 including:
1. 4% increase in volume.
2. 2 points of increase from FX.
3. No growth from price.
1. This growth was achieved in a year, where Co. overcame $2b
of patent expires.
1. A major contributing factor to topline growth continues to be
2. In 4Q07, revenue was approx. $1.1b, 59% increase vs. 4Q06.
3. On a full-year basis in 2007, revenue was approx. $4.3b, 130%
increase over 2006.
1. Continues to be extremely pleased with the progress of
GARDASIL in terms of US market penetration and global rollout.
2. Based on international approvals, recommendations,
reimbursements, and launches.
1. Co. is well positioned to continue to build on the success
of this franchise in 2008.
3. In 4Q07, revenue was $339m, $268m of which was in US.
4. US GARDASIL's sales were down sequentially in 4Q07, due to
seasonality and some supply chain dynamics in the public
1. Seasonality in what Co. calls well visits for adolescent
cohort is heaviest in 2Q and 3Q.
1. Results in 63% of well visits typically occurring in 2Q
2. In 2007, public sector sales were heavily weighted towards
1Q and 2Q, driven by very rapid adoption by all 55 projects
following Nov. 2006 VFC contract.
1. 64% of VFC sales occurred in 1Q and 2Q.
5. Outside US, Sanofi Pasteur MSD JV recorded end-market sales
for GARDASIL of $231m in 4Q07.
1. Despite the seasonal spite in US demand for GARDASIL in
1. Global end-market sales for GARDASIL reached a new high in
2. In its first full-year on the market, 2007 revenue was
6. GARDASIL's performance in 2007 has been unprecedented for a
1. Estimates that more than 7m 9-26 year old females have
received at least their first dose of GARDASIL.
2. Significant opportunity remains with over 29m 9-26 year old
females that are yet to receive a dose of GARDASIL.
3. In 2008, Co. is focusing on increasing penetration across
the initial 9-26 year old cohort and improving the
compliance rates for second and third doses.
4. Anticipates expanding label for GARDASIL through incremental
indications including an indication for adult women through
45 years old.
5. Indication for adult women would more than double the
eligible population for GARDASIL in US.
8. To date, GARDASIL has been approved in 93 countries, most
under accelerated review, and has launched in 76 countries.
9. In 2008, anticipates launching GARDASIL in over 20 markets.
10. As Co. continues the global rollout of GARDASIL.
1. Looks forward to capitalizing on this significant
2. As per plan, international launches are just now beginning
to pick up and will be a significant driver for franchise in
2008 and beyond.
1. In 4Q07, revenue was $270m, 187% increase over 4Q06.
1. This strong quarterly result is the function of two major
1. Continues to make progress within cohort's eligible for
second dose VARICELLA in the first full-year of new
2. As of Dec. 31, estimates 80-85% penetration of the routine
4-6 year old second dose cohort.
3. 20-25% penetration of cumulative catch-up population.
2. As a result of back-to-school surge that makes "3Q" a peak
period for youth vaccine business and unprecedented demand
for VARIVAX in 2007.
1. Co. was able to ship approx. $75m in back orders in 4Q07.
2. By 4Q07-end, back orders for VARIVAX were pretty much
2. Co. is further increasing production of VARIVAX.
3. Expects to meet anticipated market demand for varicella,
measles, mumps, rubella vaccine through VARIVAX and MMR II.
1. In 4Q07, revenue was $1.2b, up 20% YoverY.
2. On a full-year 2007 basis, revenue was $4.3b, up 19% over
3. Strong growth for SINGULAIR was driven by:
1. Continued market share gains in US for both asthma and
allergic rhinitis claims.
2. Rapid growth in foreign markets.
3. On a full-year basis, saw 27% YoverY growth.
1. As a result of additional indications and a differentiated
4. Despite the recent slowdown in respiratory market share and
potential new competitive threats.
1. Continues to anticipate strong growth for SINGULAIR in 2008.
1. 4Q07 revenue was $796m, up 1%.
2. On a full year basis for 2007, revenue was $3b, 3% decline.
3. In its last full qtr. of marketing exclusivity, FOSAMAX has
performed extremely well, due to:
1. Differentiation on efficacy and that relates to hip fracture
indication and spine fracture indication.
2. Relevant managed care status of the brand now and its
generic counterpart in the future.
4. Authorized generic strategy is in place to maximize the value
of the franchise after patent expires.
5. With Zocor expiry in the past, Co. has necessary new and
in-line products to drive revenue growth through this event in
8. Total Revenues (Including 50% of JV):
1. For 4Q07, total revenue was $7.5b, 7% increase doing the same
adjustment in the base period.
2. On a full-year basis for 2007, revenue was $28.8b, 10%
increase vs. comparable 2006 figure.
3. Has opportunity to capitalize on Co.'s robust product
portfolio and deliver solid revenue growth through 2010.
4. Despite certain patent expires during this time frame.
1. Continues to expect revenue growth of 4-6%, on a compounded
annual basis driven by:
1. In-line products.
2. Launched products.
3. Potential new products.
4. This 4-6% includes 50% of revenues of JVs from 2005 base.
5. 2008 revenue guidance, reaffirmed all elements of Co.'s
full-year revenue guidance.
9. P&L (materials and production):
1. In 4Q07, materials and production were $1.5b, includes:
1. $118m for costs associated with global restructuring
program, primarily related to accelerated depreciation and
asset impairment costs.
2. Excluding these costs, material and production decreased 5%
10. Product GM:
1. 4Q07 product GM was 75.3%.
1. Reflected a 1.9 percentage point unfavorable impact related
to restructuring costs.
2. Excluding these restructuring costs, Co. had a PGM of 77.1%.
3. Results were affected by the final product mix.
2. Full-year 2007:
1. Adjusted product GM was 76.6%.
1. Continues to anticipate PGM in 77-78% range.
2. Guidance excludes portion of restructuring costs that will
be included in product costs and will affect the reported
PGM in 2008.
11. Marketing and Administrative Expense :
1. 4Q07 marketing and administrative expense was $1.7b, 27%
decrease over 4Q06, which includes:
1. $455m gain related to insurance proceeds, which Co. was
awarded in the arbitration with its upper-level excess
product liability insurance carriers.
1. These claims related to coverage for costs incurred in
VIOXX product liability litigation.
2. In connection with US VIOXX Settlement Agreement, MRK
recorded a pre-tax charge of $4.85b, represents fixed
amount to be paid by it to settle qualifying claims.
2. During 4Q07, Co. did not increase reserve related solely for
future legal defense costs of VIOXX litigation.
1. In 4Q07, spent approx. $200m in VIOXX legal defense costs,
which resulted in a reserve as of 12/31/07 of approx. $522m
solely for its future legal defense costs related to VIOXX
1. Of which approx. $80m has now been allocated to MRK's
anticipated future costs to administer the settlement.
3. As of 12/31/07, Co. had an aggregate reserve of approx.
$5.372b related to VIOXX litigation.
4. Excluding these charges in 2006 and 2007, M&A decreased 2% in
4Q07 and increased 4% for full-year.
1. Significant portion of the increased spending is
attributable to fluctuations in FX rates, which have
increased significantly during the last 12 months.
2. Sees this as a benefit on Co.'s topline revenues.
3. Does increase its marketing and administrative dollars
5. Regardless to FX, Co. maintains a healthy amount of support
behind its growing core and successful new franchises, many of
which are continuing their global launch activities
market-by-market in 2008.
6. Reflecting Co.'s commitment to realizing efficiencies
throughout it and optimizing its cost structure.
1. Component of marketing and administrative consisting of SG&A
cost, which support core operations remained down over prior
7. Comfortable with the focus of these investments.
1. Continues increased focus on cost management.
8. Seeing the positive benefits of practical ongoing cost
management initiatives including the redesign of many of Co.'s
critical business processes.
9. In 2008, continues to anticipate marketing and administrative
expense to be approx. $7.8-8.0b.
1. R&D expenses were $1.4b, 20% decrease YoverY.
1. 10% growth excluding (indiscernible) the in-process R&D
charge in prior year.
2. Full-year 2007:
1. R&D expenses were $4.9b, 2% increase YoverY.
2. Making adjustment for the certain in-process R&D charge and
restructuring in the base period is a 15% growth.
3. Remains committed to fully funding Co.'s core internal R&D
ensuring the continued success of all compounds in all phases
4. Internal R&D growth remains strong.
5. Continues to invest in life cycle management programs for
GARDASIL, JANUVIA, and ISENTRESS.
6. Late stage clinical trials on:
1. MK-0524, MK-0364, MK-0974, MK-07418 from NovaCardia.
2. MK-8669 from ARIAD.
4. Other investigational vaccines.
7. Continues an active external collaboration and business
development agenda funding:
1. Clinical grant programs.
2. Third-party scientific collaborations.
3. Licensing transactions.
1. All of that within Co.'s R&D line.
8. 2008 Guidance:
1. Reaffirmed guidance that Co. previously given of $4.7-4.9b.
13. 4Q07 Restructuring Costs:
1. Total costs associated with global restructuring program was
1. $118m for asset related charges were included in materials
and production line.
2. Restructuring cost line reflects $156m of costs for employee
separation and other related costs associated with approx.
1,200 position eliminations, bringing the total to 7,200 since
the initiative started.
3. As part of Co.'s restructuring of its operations, additional
costs related to:
1. Site closings.
2. Position eliminations.
3. Related costs.
1. Will be incurred in 2008.
4. Anticipates aggregate 2008 pre-tax expense related to these
activities to be $100-300m.
S3. Income and Outlook (P.K.)
1. 4Q07 Equity Income:
1. Equity income from affiliates was $796m, reflects:
1. Continued success of Merck/Schering Plough cholesterol
franchise in US and Europe.
2. Increasing contribution from Co.'s European vaccine JV
Sanofi Pasteur MSD.
1. Recent public confusion surrounding the enhanced results
although disappointing, has caused Co. to consider whether
any different scenarios regarding to financial impact to the
franchise are appropriate.
2. At this time based on limited data, it is too early to make
and form judgments or change long-term trajectory expected
3. At this time, Co. believes that it is looking at more of a
reaction in the market than a real ongoing trend.
4. Equity income contribution that Co. record is from a
portfolio of several JV and partnerships.
5. On an annual basis, there are always positives and negatives
within the portfolio.
6. At this time, Co. is not changing range of $3.0-3.3b.
2. Taxes on Income:
1. Effective tax rate of 48.7% and 2.8% for 4Q07 and full-year of
2007 respectively reflects impact of:
1. US VIOXX Settlement Agreement charge.
2. Civil government investigations charge.
3. Gain related to insurance arbitration settlement.
2. Non-GAAP tax rate for 4Q07 and full-year 2007 were 18.4% and
1. 24.1% is at low-end of Co.'s guidance range.
2. Rates reflect the favorable impacts of an adjustment related
to the termination of Puerto Rico tax benefits and 4Q07
adjustments related to certain federal and state tax items.
3. Reaffirmed that full-year 2008 tax rate guidance range stays
3. Net Income & EPS:
1. On a GAAP basis, Co. had a net loss of $1.6b or on a per
share basis that was a loss of $0.75.
2. Excluding the restructuring charges, the big litigation
reserves, and proceeds from an insurance gain, non-GAAP EPS
was $0.80 per share.
2. Full-year 2007:
1. Net income was $3.3b.
2. GAAP EPS was $1.49.
1. Excluding restructuring charges, litigation reserves, and
proceeds from an insurance gain, non-GAAP EPS was $3.20.
4. Full-year 2008 Guidance:
1. Reaffirmed 2008 non-GAAP EPS guidance of $3.28-3.38, excluding
2. Anticipates GAAP EPS to be $3.80-4.00.
1. Co. remains on track in terms of strategy and performance to
deliver long-term double-digit EPS growth from 2005-2010,
excluding certain items.
2. Continues to fully invest in all of Co.'s key strategic
3. 2007 represented an important step in a multi-year journey to
return MRK to its leadership position in the pharmaceutical
4. While much has been accomplished over the last 12 months, many
opportunities remain, and Co. looks forward to capitalizing on
them in 2008 and beyond.
QUESTION AND ANSWER SUMMARY
OPERATOR: (OPERATOR INSTRUCTIONS). Your first question is from
Barbara Ryan with Deutsche Bank.
BARBARA RYAN, ANALYST, DEUTSCHE BANK: Thank you so much for
taking my question. Just a short one, Peter, for you. I guess you
addressed it. It was really related to the tax rate, and I know you
went through the other reasons, but I know in Pfizer's case, too,
there was a lower tax rate in part because of the geographic mix
which really swung, and then it happened to be, in their instance,
low tax countries as well, and I am just wondering if that played a
role as well?
PETER KELLOGG, EVP, CFO, MERCK & CO., INC.: Yes. Barbara, this
is Peter. Thanks. Every quarter we have a little bit of geographic
mix impact although I wouldn't say that was the primary driver this
quarter. The reason our tax rate was a little off trend in the
fourth quarter was again I am referring to this now on a non-GAAP
basis which is I am assuming what you're looking at. It was more
related to the termination of the Puerto Rico tax benefits we were
seeing, and also some fourth quarter adjustments to certain federal
and state tax items, and these were really kind of items that touched
our reserves relative to what our expectations were and as we close
these things out, we're able to adjust the reserves.
It is sort of each quarter we look at our reserves relative to
our what we know about our tax positions and quite frankly in the
fourth quarter, these were more adjustments to that. There is a
little bit of mix, but it is much more the adjustments related to
those three items that cause this benefit. Again, I would highlight
that it is more happened in the fourth quarter as we move into 2008,
I think we run right back into our ongoing tax rate that we always
talked about in terms of guidance and what you should expect.
GRAEME BELL, SENIOR DIRECTOR - IR, MERCK & CO., INC.: Next
OPERATOR: The next question is from Jami Rubin with Morgan
Stanley. The next question is from John Boris with Bear Stearns.
JOHN BORIS, ANALYST, BEAR STEARNS: Okay. Thanks for taking the
questions. Peter, I think you characterized the Zetia Vytorin
situation as a reaction in the media rather than an ongoing trend.
Just a three-part question to this. How many weeks or months do you
need to be able to establish a trend for the joint venture?
Secondly, are you seeing any impact on your ex-U.S. business from
all of the media hype in the United States over the enhanced results,
and then the third part, can you talk about first line use in the
United States for Vytorin and what percent of first line use is made
up of VYTORIN's use? Thanks.
PETER KELLOGG: John, thanks. So first of all I think it is
hard to -- the data we have right now is obviously the daily scripts,
and we have one weekly tabulation on that, so we're very cautious
about reading daily scripts. We acknowledge that's the only thing
out there to look at, but we often find it doesn't always represent
exactly the trend that you want or doesn't sync well with the weekly
or monthly recaps, so we're very cautious about looking at daily
scripts and drawing broad full year conclusions that, and I think
quite frankly there has been a tremendous amount of various points of
view and opinions floating around in the market that can be
disruptive and create reactions. I really believe that as the full
body of evidence is going to digest it in the medical community, and
as the full data of course of the trial is released, I would expect
to see the market trends really emerge at that point based on a much
more complete and scientific evaluation of what the trial really
means or doesn't mean.
Secondly, the ex U.S. business really has not been affected.
This has been pretty much a U.S. phenomena at this point, and I
think again the international medical community is I think not
reacting quite as much to some of the news lines, and probably most
of the news lines are a little more U.S.-centric. Related to the
first line usage of Vytorin, to be modest, I am a little bit -- I
apologize -- not able to answer that question, and I think maybe we
can come back to you on that later in the call. John, we noted that
and let me come back later in the call if we have the data. I
apologize for that one.
RICHARD CLARK, CEO, PRESIDENT, MERCK & CO., INC.: One other
point, John, when you think about Zetia and Vytorin ex-U.S., we
certainly had a very strong fourth quarter. For example, Zetia grew
at 40% versus fourth quarter '06, and Vytorin grew at 84% in Europe,
and in the Far East was 67% for Zetia and greater than 100% for
Vytorin, so we continue to see strong growth for Zetia and Vytorin
outside the U.S.
GRAEME BELL: Next question, please.
OPERATOR: Next question is from Jami Rubin with Morgan Stanley.
JAMI RUBIN, ANALYST, MORGAN STANLEY: Thank you. Can you hear
me okay? Great. Just a comment. Peter, we've discussed this a lot
before in the past, but your stock is down 25% since the ENHANCE
controversy on January 14th, and I would just think with $10 billion
in cash from operations you just received $2.5 billion from
AstraZeneca, and Vioxx settlement is now behind you, hopefully, we're
really close, and I can't think of a better time to announce a major
stock buyback program. My question also has to do with again going
back to ENHANCE. Are you aware that the negative publicity has in
any way affected patient dropouts in the IMPROVE-IT trial, and my
second question -- and I just want to ask this. With Gardasil sales
outside the U.S. or rest of world sales that you book, your sales
were $70 million versus $90 million in the third quarter yet you're
in the process of launching in a number of markets. Can you give us
a sense of what's going on and how we think about that trajectory
going forward? Thanks.
RICHARD CLARK: So a couple questions. Why don't we take them
in order you laid them out. I think you're making a comment about
the stock buyback. I think the only thing I just remind everybody
and you see in our press release, as of December 31st, we had $5.1
billion approved by our Board under the current buyback
authorization, and that obviously compares to $6 billion that was
outstanding as of September, and clearly the points you made and lost
on us. We understand exactly what you're saying.
On ENHANCE on the IMPROVE-IT dropout, I don't think we have seen
any reaction at all in that trial accrual or participation, and nor
would we necessarily expect to see that at this point. Related to
Gardasil sales, I think clearly one of the things that you do see as
you roll out bumps and ins and outs and so forth and some volatility
sometimes as you go through quarters, there were a couple of markets
that had pretty heavy activity in Q3 and then didn't have quite the
same activity in Q4, but we don't really read that as a trend at all.
And these are kind of some of the short-term volatility elements you
get in supply chain or just a rollout activity in the market.
Quite frankly, when we stack up the all the different data
points and the approvals and the authorizations and the activity
level, and the awareness of Gardasil and the international market
that we're looking at, the kind of things we look at when we put
together our plans, really, Gardasil is poised to have a really good
year internationally. We aren't really concerned about quarter
fluctuations, and I would encourage everybody to look forward and
recognize not only the number of approval that is have come through
but how many of them were actually accelerated approvals and how good
our authorization and reimbursement status is around the world. I
really think we're headed for something where I wouldn't worry as
much about quarterly fluctuations during a launch as really looking
at the preponderance of all of that positioning.
PETER KELLOGG: I would make a few comments, Jami. First, as we
said, Gardasil sales in 2007 were $1.5 billion, and we have a
tremendous amount of confidence and expect continued growth globally
for Gardasil in 2008 above that number, and so we're very confident
in that as we go throughout the world. The second point which we
said in the past is that females 9 to 26, if you look at the EU and
U.S. and other high income markets, it is about $118 million. As
you know, with our December submission for 27 to 45-year-old women,
that 118 goes up to 264, and so there is a substantial uptick and up
growth we can provide based on enhanced indications for the vaccine,
but we're very confident in where Gardasil is going to be in 2008.
GRAEME BELL: Can I go back to John's question if I may for a
moment with regard to managed care and the use of Vytorin. In the
aggregate managed care organizations have all recognized a need for a
product with excellent LDL efficacy, notwithstanding the availability
of generic simva. In terms of the book of business, we basically
indicate that about 93% of the business comes from continued therapy.
4% of our business comes from patients who are new to market, who
are initiating therapy and been naive to therapy previously. 2% of
it comes from brand switches, and about 1% of utilities with add-on,
so that gives you perspective in terms of where the business comes
from relative to Vytorin. With that, Amanda, can I have the next
OPERATOR: The next question is from Tony Butler with Lehman
TONY BUTLER, ANALYST, LEHMAN BROTHERS: Thanks very much. Given
much of the hoopla from the congressional investigation, I am
curious, Dick, how you're feeling about the regulatory nature of
Cordaptive, and do you think the FDA is actually shy about approving
a new therapy despite the fact that they were very bullish about
niacin-based outlook studies on the call Friday and second to that
question is, are you actually increasing the number of details today
for Vytorin and Zetia, and more over can you go over or express
comments regarding the future for DTC ads, thanks.
RICHARD CLARK: Certainly speaking first of Vytorin and Zetia, I
think the joint venture between Merck and Schering Plough in the last
few weeks has done an outstanding job of reaching out to healthcare
professionals, approximately 95% of the top specialists and 90% of
PCPs have been called on by our representatives post the press
release. All of these representatives were provided with our letter
that we have sent, and really have follow-up calls and so we're
really helping the physicians position the products correctly, and I
think we've got favorable response from that as well as favorable
response from the patient ads that have been put in, a majority of
these papers. I think in in addition, all of the managed care
organizations have been contacted by us.
There haven't been any changes, so I think we have done a fairly
good job of focusing our physicians to make sure we can put in in
proper context and provide them the information that they needed, and
we're continuing to get good feedback from that to your question with
Cordaptive, it was reassuring at the FDA call on Friday where they
said at this point, we believe it is premature to embark on any
systemic changes, and we approved lipid lowering drugs because we
believe there is a long track record of success in the approach we
have followed over the past several decades. I think that is
reassuring from not only a Cordaptive basis, but to make sure
patients stay on their cholesterol lowering products in order to
lower their LDL for patients would get off of it based on media hype,
that would be terrible from a healthcare standpoint. I think that's
important. We're evaluating our DTC advertising as we move forward.
GRAEME BELL: Tony, I would just add that as we stated in
December with Peter Kim at the annual business briefing, we went
through with you how extensively we have studied Cordaptive as we
were approaching this regulatory submission. We won't go through
that again. I would point you back as a point of reference to our
confidence in terms of the filing relative to those remarks. So next
question, please, Amanda?
OPERATOR: The next question is from Tim Anderson with Sanford
TIM ANDERSON, ANALYST, SANFORD BERNSTEIN: Thank you. A few
questions, please. I would have to imagine that you guys have
heavily contemplated getting full enhanced results out earlier than
the late March meeting of ACC, maybe published in something like a
medical journal. Until results are published, your reps of course
are very limited in what they can say to prescribers, so any comments
on that? The second question just going back to DTC, I thought the
original word out of Merck was that DTC was temporarily suspended but
that it would resume in very short course, and I am wondering if that
changed, and then on Cordaptive, do you expect that to likely go up
for an FDA advisory committee?
RICHARD CLARK: On the last point we have not been advised of
any advisory committee to date. Your point concerning publishing,
we're working with the lead investigator who will submit the enhanced
study for publication and make sure that is done as soon as we can,
and so that is being certainly studied.
TIM ANDERSON: Regarding DTC?
RICHARD CLARK: Yes. DTC we're still evaluating we make sure we
do it the proper way. I would say it is temporarily on hold.
GRAEME BELL: Thanks, Tim. Next question, please.
OPERATOR: The next question is from Harlan Sonderling with
HARLAN SONDERLING, ANALYST, COLUMBIA MANGEMENT: Yes, thank you
very much. I wanted to ask in light of the ENHANCE trials, whether
you are changing the sales effort on the ground, that is you're not
changing yet the DTC advertising beyond the temporary suspension.
You've commented on the results, the getting the enhanced results out
and what are your reps telling physicians and have you changed that
RICHARD CLARK: We are making sure that we have all available
resources for both the joint venture and the companies to make sure
that we're able to get out our press release to make sure that we're
able to show the healthcare providers the position we put together
from a letter standpoint. The most critical thing we have to make
sure that we're able to continue to deliver the message that LDL
lowering is key. So in some cases for LDL lowering, the patient may
do well on a generic simvastatin, in many other cases they won't be
able to reach full. If that's the case, Vytorin and Zetia are the
branded products that we've been able to prove clinically lower LDL
to the right impact and have a better chance to reach the goal. And
those messages haven't deviated.
We have very safe products in the marketplace, and they're very
important part of the management programs, and our professional
representatives continue to deliver those messages and ask those
questions. We are obviously not backing off those two products,
because they're so important from a health management standpoint, and
we're making sure that we can answer any questions, because with the
media hype there is a great deal of confusion out there, and we have
obviously the excellent comments by the FDA and the other societies
that come out and said LDL lowering is key to this, and quite frankly
there are no better products for LDL lowering than Vytorin and Zetia.
GRAEME BELL: Next question, please, Amanda.
OPERATOR: The next question is from James Kelly with Goldman
JAMES KELLY, ANALYST, GOLDMAN SACHS: Thank you very much. I
just wanted to ask a question to get a little more detail on the
trajectory of the vaccines. I know you mentioned about the
seasonality elements, but there were also some other elements, and I
apologize if you did address this in the prepared comments and I
missed it, of some catch-up vaccinations and whether or not that's
already substantially done as far as you're hearing back in the
chicken pox second dose and catchup there or any of the other pieces
that may be other than seasonality? Thank you.
PETER KELLOGG: James, this is Peter. Thanks. So not a lot of
different parts to to your question quite frankly. Yes, there is
seasonality in the vaccines business as I mentioned, just based on
the pattern of well visits for adolescents. You do see a fairly
healthy back-to-school surge. I also commented on the call, and I
hope this is directly addressing it, that as of year end we estimate
that 80 to 85% penetration of the routine four to six-year-old second
dose cohort of Varivax has been achieved, and 20 to 25% penetration
of the cumulative catchup population has been achieved. The other
thing is we did have back orders coming out of Q3, and I mentioned
that in Q4 we shipped $75 million to completely fulfill that back
order situation. I think that hits the point that you were asking,
if I missed it, please come back. I apologize.
OPERATOR: Next question is from Roopesh Patel with UBS.
ROOPESH PATEL, ANALYST, UBS: First on Vytorin and Zetia, can
you summarize for us the clinical data that's expected to be
presented for Vytorin and Zetia besides ENHANCE over the course of
the next twelve months and then on Gardasil, just a clarification.
Peter, you mentioned supply chain dynamics influenced fourth quarter
sales. Was that just the VFC purchasing patents over the course of
the year or something else that influenced fourth quarter sales?
PETER KELLOGG: Hi, Roopesh. This is Peter. Let me take it in
reverse order. The supply chain dynamics were much more in the
public sector. You're right. It was really the VFC contract, and
what we saw was very rapid adoption in pickup of the product by the
all the different various public sector sales entities, and so as a
result that drove a heavier sales volume in Q1 and Q2 of us shipping
product out, and then as we went through the balance of the year we
saw that some of the supply chain items balance out and get kind of
sorted through, and so as we came to the third and fourth quarter we
ended up with a little bit of a rebalancing of some of that
inventory. That is a very fragmented system and obviously that is
kind of just a dynamic that occurs sometimes when you roll off the
vaccines. Hard to know exactly also what's going on because there is
an enormous amount of inventory reporting up there. It was all
GRAEME BELL: Roopesh, with regard to the first part of the
question with regard to expectations of clinical data dissemination,
obviously we've got ACC in March for ENHANCE. With regard to SEIZE,
we expect to have the data in 2008 on SEIZE, and then you have shop,
the expectation is we have clinical data in 2011. As we mentioned,
IMPROVE-IT, which is still enrolling, we expect the data to be out in
2011 as well. Between now and 2011, 2000-- the four studies will be
disseminated. Next question, please, Amanda.
OPERATOR: Your next question is from David Risinger with
GRAEME BELL: David, please go ahead.
DAVID RISINGER, ANALYST, MERRILL LYNCH: Yes, can you hear me?
GRAEME BELL: Yes.
DAVID RISINGER: To follow up on SEIZE and IMPROVE-IT, if you
could please characterize what Merck expects out of the SEIZE study,
that would be helpful, and also if you could please excellent on
whether there is the possibility of accelerating IMPROVE-IT or the
possibility of an interim look at the data before 2011 that could be
made public. Thank you.
GRAEME BELL: David, with regard to those two studies, clearly
there are protocols in place, and we shared some of that information
with you. We certainly can't foreshadow when exactly the results
will be available nor do we have the exact setup in terms of the data
monitoring boards and how the data will roll out of these studies.
Clearly the protocols are in process and there is one particular
study looking at aortic stenosis and another is looking at another
patient population. Across ENHANCE, SEIZE, SHARP and IMPROVE-IT,
obviously IMPROVE-IT is the critical outcome constituted any all of
that. We feel that there will be an awful lot of incremental data
that we'll gather with regard to these compounds. Next question,
OPERATOR: The next question is from Chris Schott with Banc of
CHRIS SCHOTT, ANALYST, BANC OF AMERICA: Thank you. Three quick
questions. Maybe on Gardasil in Europe, obviously saw some strong
acceleration this quarter. Give us more color in terms of what
countries were driving this or initial contracts driving that and
maybe where you stand versus your competitor in those markets with
regard to any tenders that have occurred. For Gardasil in the U.S.
just to clarify, do we expect the vaccine for children sales to be
front half loaded going forward or is that an artifact of what you're
mentioning of the initial rollout and finally if you can give us an
update on the potential timing of FDA sign off for new batches of
varicella bulk, please thanks.
PETER KELLOGG: Let me say the second one if I can which is the
vaccines for children and supply chain. Good question. We don't
anticipate this to be an annual cycle at all. It is very much an
artifact of the approval and the new contract established in late
2006, so then the market reaction is picking up supply and so forth.
This is not an annual cycle we expect. It was much more related to
a, if you will, a approval and changing additions since the market
reacted to that. I don't think there would be any expectation of
seasonality per se in the supply dynamics for the public sector.
With--related to the Gardasil international markets, in some
ways in the international rollout, first of all, I think it is way
too early to have a lot of input on tenders and so forth. I would
say that we don't see anything that is an usual bias at this point
relative to any of the markets rolling out. Typically you see
markets vaccines more rapidly than others, and some some of the
bigger markets obviously you're planning a role, but I don't think
there is anything really that a strange dynamic in the rollout at
this point. I would say that all the numbers are relatively early
days, so we're just beginning to roll out and expect 2008 to be an
interesting year to watch. Maybe more specifically, Dick, do you
have anything you would comment on?
RICHARD CLARK: On the bulk issue with the FDA from a vair sell,
it is too early to tell when we would finalize our submission and
have approval. As I said on the last call, we continue to see
excellent progress, and excellent potency out of the lots being
manufactured, and so we're putting all of the required data together
in the submission for the FDA, and we can't give a date yet for that.
GRAEME BELL: Amanda, given the time, we'll have time for one
more question, please.
OPERATOR: Your final question is from Seamus Fernandez from
SEAMUS FERNANDEZ, ANALYST, LEERINK SWANN: Thanks very much. A
couple of quick questions. Can you give us a little visibility on
when the 30-month stay expires on Nexium and any kind of possibility
of a Nexium patent settlement would impact the contribution to Merck
from AZLP? If there were a settlement, it is unclear to me how that
would be booked into the overall scope of the partnership. Just a
second quick question. Peter, you mentioned new competitive threats
in asthma and allergic rhinitis. Can you give us a little bit more
of a sense of what those new competitive threats are in your view and
also last year we had a very, very strong allergy season, and the
seasonality in Singulair was high. Can you give us a sense, do we
have any visibility now on whether or not that season is expected to
be equally strong this year or not, and then just a last question
quickly on Q4 costs related to the vaccine recalls that we saw. Were
those material in any way and can we kind of expect those to recur or
not recur in the first half of this year? Thanks very much.
PETER KELLOGG: So you get the award for the most comprehensive
set of questions and let me quickly go through them. I am afraid if
we miss one we need to recap. First let me start back with the
Nexium. Basically the stay goes through April of this year, so
that's the date where you would see the 30-month stay would expire.
Quite frankly after that we have no idea what might happen. However,
obviously we are going through normal legal steps now and working on
that. If there was some sort of a settlement, it is unclear what the
settlement would be, but it is unclear it would really affect 2008
anyway. That would be something all in the works, so way too early
to comment on that, but I would say at this point we're following the
normal steps and processes related to that, so nothing really new to
report and nor any sense of anything new that would happen really in
that situation. Bruce Kuhlik is here, do you have any other comment
BRUCE KUHLIK, GENERAL COUNSEL, MERCK & CO., INC.: Peter,
thanks. The stay, the initial one expires in April, but the fact the
stay expires does not have any bearing on meaning actually that a
generic would launch at that time, and we're continuing actively to
defend those installations.
PETER KELLOGG: Okay. In terms of the asthma season, I think it
is a little too early to start reading into the asthma season. We
would -- as a CFO I would love to have the crystal ball and at this
point I don't have it, so we have to play the season as it goes. We
really don't have any leading indicators, and I am not sure there
are. On the competitive threats relative to Singulair, what I was
referring to is new brand entrants in 2008 we're anticipating, and
the normal lift, and I think we're confident in the guidance we've
given for 2008 for Singulair, so I didn't mean to create concern, I
just wanted to highlight that Singulair has been barreling ahead as
you mentioned partly because of the asthma season we've been
experiencing and so forth and to have a $4.3 billion drug growing 19%
full year in 2007 is something that is pretty great. On the other
hand what we're highlighting, there are other factors. As you say,
not sure the asthma season and there are new competitors coming into
the market. That's all I would say.
GRAEME BELL: Seamus, regarding your question on the costs of
the recall during the quarter, it wasn't material in any particular
way, so let me just give you perspective. The total cost of the
recall was approximately $40 million in the fourth quarter,
approximately half of that cost was associated with sales credits to
customers and the other half was associated with inventory that we
had to write down that we had in supply chain, so we didn't consider
that Pedovax recall to be a material event to our results.
PETER KELLOGG: I think that covers all the points that were
asked. Good list of questions. Thanks.
GRAEME BELL: So that last question concludes today's conference
call. The information from today's call, both the transcript and the
replay will be available on the website for the next several months,
and as always, Mike Nally, whose birthday it is today, and I will be
available all day to take your calls and answer your incremental
questions. With that let me pass it back to Dick for concluding
RICHARD CLARK: Thank you, Graeme, and thanks for joining us on
the call today. As we have clearly stated, we're very pleased with
the fourth quarter and full year 2007 results. We're not wasting any
time looking in the rearview mirror in congratulating ourselves.
We're proud of how far we've come, but we have tremendous amount to
do before we hit the finish line. 2008 represents the halfway point
towards our long-term guidance, and new challenges pop up every day.
We begin our 2008 with a sense of urgency and a sharp focus on what
we need to do.
We'll continue to work hard to grow our pipeline and reengineer
our business to deliver sustained revenue and earnings growth beyond
2007. I think it is also important to note that in addition to all
of the activities we're talking about, we have 150 country launches
in 2008 for our products and vaccines. That's 150 new product
launches. Thank you again. We appreciate your interest and
participation. Operator, thank you very much for your assistance.
OPERATOR: This concludes today's conference call. You may now
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