MRK
#Thank you, Rob, and good morning, everyone
This morning I'll provide highlights on the performance of Global Human Health for the second quarter
And my comments will be on a constant currency basis
Global Human Health delivered another solid quarter
Worldwide sales of $8.8 billion grew 2% with contributions from launched products including KEYTRUDA, ZEPATIER, and BRIDION as well as our vaccine portfolio more than offsetting the continued impact from LOEs
We also had another strong quarter outside of the U.S
with growth of 8%
I'll highlight a few of our key franchises and product launches, starting with KEYTRUDA
We continue to build our leadership position in immuno-oncology, as we execute on the great opportunity we have with the launch of KEYTRUDA
In the second quarter we added to our momentum with four new indications in the U.S
and an additional indication in Europe
Sales grew to just over $880 million, a very significant increase over prior year
In the United States, KEYTRUDA sales continued to build across multiple indications with lung cancer now contributing to roughly half of the sales
Sales in the fourth quarter – or sales in the second quarter also reflect favorability of approximately $40 million due to the timing of customer purchases
In first-line lung cancer, KEYTRUDA is the only approved anti-PD-1 therapy
And we've seen a strong adoption of KEYTRUDA as monotherapy in high PD-L1 expressive populations
And KEYTRUDA has quickly become standard of care in that setting
While still early days for the KEYTRUDA/ALIMTA combination, feedback from oncologists has been positive following the FDA approval in mid-May
In fact, the combination was added to NCCN guidelines a couple of weeks ago as a recommended therapy in first-line non-squamous lung cancer regardless of PD-L1 status
We've also start to see a greater contribution from lung cancer outside of the U.S
KEYTRUDA is now approved in the first- and second-line lung cancer settings in more than 60 countries
We continue to achieve reimbursement in more markets
And we're seeing a steady increase in patients being tested for PD-L1 status
In addition to momentum in Europe, we've also seen strong uptake in both first- and second-line lung in Japan
That follows our launch in the first quarter
Outside of lung cancer, KEYTRUDA continues to be the leading anti-PD-1 therapy in metastatic melanoma in the United States and in many markets around the world
We've also seen strong launches across bladder cancer, head and neck cancer and classical Hodgkin lymphoma as well as early interest in MSA-high (sic) [MSI-high], the first tumor agnostic indication
We are excited about the continued growth of KEYTRUDA across indications
We believe our breadth of approved and future indications across tumor types will continue to establish KEYTRUDA as a foundation for the treatment of cancer
In addition, we are very much looking forward to collaborating with AstraZeneca in oncology as announced yesterday
We believe LYNPARZA can be a very important product in different indications over time
And the combination of our proven commercial success in oncology launching KEYTRUDA, with AstraZeneca's strong experience, will enable us together to make this product a tremendous success
Moving now to JANUVIA
Global sales for the JANUVIA franchise were $1.5 billion, a 7% decline, primarily driven by the U.S
In the second quarter, we saw solid volume growth of 3% in the U.S
But we also saw continued pricing pressure as we've discussed before
There was also lower inventory levels being held in the channel
JANUVIA continues to maintain DPP-4 leadership and to be a preferred add-on after metformin
We look forward to the opportunity to broaden our diabetes portfolio with the SGLT2 inhibitor monotherapy and in combination with JANUVIA, partnered with Pfizer
That has a PDUFA date at the end of this year
Moving now to our Vaccine business
Sales of $1.4 billion grew 11% due to strength in GARDASIL and approximately $70 million of sales from the terminated joint venture with Sanofi
In the United States, GARDASIL continues to see good underlying demand with very strong first dose coverage rates
But we're starting to see some impact from the transition from a three-dose to a two-dose regimen
GARDASIL sales outside of the U.S
grew this quarter, primarily driven by the JV termination
Moving now to Hospital and Specialty
Successful launches of ZEPATIER and BRIDION more than offset declines in CUBICIN, REMICADE, and ISENTRESS
ZEPATIER sales reached nearly $520 million, driven by strong underlying demand in the U.S
, Europe, and Japan
We will continue to focus on expanding ZEPATIER's utilization globally, but recognize that uptake may be impacted by the ongoing decline in overall patient volumes in many markets and increased competition
BRIDION had another good quarter with growth of more than 40%, driven by strong demand across ex-U.S
markets and the continued success of the launch in the U.S
remains the largest opportunity for BRIDION moving forward
In closing, we drove solid performance across many products this quarter, delivering growth despite a more than $800 million headwind from loss of exclusivity
We continued to execute well on our product launches
And we look for additional opportunities across our broad portfolio to drive growth through the remainder of 2017. With that I'll turn the call over to <UNK>
Good morning
So if you look at JANUVIA, the IMS-2X (22:37) volume growth in the U.S
It was about 3%
However, it's not as strong growth as what we experienced last year, where it was about 4.5%
I've been saying for a couple years now that each year, the pricing pressure gets a little bit harder than the year before
And this year is harder than last year
And I expect next year will be harder than this year
It's not discontinuous
It's just continuous pressure that builds in the channel, particularly in the United States
As we look forward, we're excited about the SGLT2 and the SGLT2 combination with JANUVIA
I believe that JANUVIA will continue to be the first choice for add-on therapy after metformin
And I think that will remain the case around the world
But a lot of patients still don't get to their HbA1c goals even with metformin plus JANUVIA
So there are many patients where they look to add on an additional oral agent, of which the SGLT2 sometimes are the right product to add
Therefore, I believe having a combination with an SGLT2 with by far the market leader in the DPP-4 class will be a competitive advantage for us
And that's why we look forward to launching that with a PDUFA date in the United States later this year
So with regard to first-line lung cancer, a couple things are important
First of all, we are certainly seeing a strong uptake overall
And in the United States, KEYTRUDA is now the leader in terms of market share in first-line lung cancer
With regard to the combination with ALIMTA, we're certainly starting to see some uptake
But it's still too early to give any specific market share for that portion of the business
But as I mentioned on the call with NCCN recommendation and reimbursement, we think that will continue to be helpful
So we are very pleased right now
About half of the sales for KEYTRUDA in the U.S
are in first-line lung
And that was the largest increase in terms of a percent of our sales
So we continue to believe that KEYTRUDA will be a mainstay for the treatment in lung cancer first-line
And this is <UNK>
So I feel very good about our position in first-line lung cancer today
And if you look at the data that we have, not just as a monotherapy but also in combo with ALIMTA, it's very, very strong
And if you think about the utilization, it's not just in academic centers for treatment of first-line lung
It's also in the community-based physicians
There, they're very comfortable using chemotherapy
So I think the combination of KEYTRUDA plus chemotherapy with the strong efficacy data that we have will continue to be a very strong position for us
Obviously we have to see what data comes out and what the results would be
But as <UNK> said, the bar is very high with the data we have
And I feel good about our position in lung today and as we move forward
And then, Tim, this is <UNK>
So anecdotally, we're hearing very positive comments
And we're hearing the comments on 021G not just from academic centers and physicians, but also in the community-based area
And the key is that we have an approved FDA indication and we have NCCN recommendation
So I don't have data yet to support anything other than what we're hearing from the field
But everything we're hearing is positive at this point
And I would expect that the combination will be used increasingly more often as we move forward
Yeah
Good morning
So if you look at first-line lung
First, let me give you a sense of testing
Right now in the United States we believe that more than three-quarters of patients are being tested
If you look at Europe, we believe that it's two-thirds of patients are currently being tested, where a country like the UK is about 90%, Germany is about 65%
So there's no doubt that we are seeing on a global basis, including Japan, significant increases in testing
And it's really becoming standard of care to test patients for their status
With regard to first-line lung, we are the leader right now in first-line lung for new patient starts
And we have about a 26% overall share, which is higher than any of the other products in first-line setting
And the majority of it I believe is based on -024, because we're just in the midst of launching the 021G results
Okay
So let me talk about MSI-high just a bit, Tony
So first of all, we're really working hard to increase the awareness for MSI testing and the value of KEYTRUDA across the tumor types
And after the June approval, there's certainly health care professional awareness that were hearing
But it's too early to see that translate into sales
It's really been detected across a lot of different cancer types
Some that are uncommon, like biliary tract cancer
And some that are very common, like colorectal cancer
If you look, MSI-high, it really is an established biomarker
And it's used often in something like colorectal cancer or endometrial cancer
But it's not really done in many of the other tumor types
So we have still a lot of work that we have to do to educate the importance of testing for those other tumor types
And I would expect over time that this will continue to be an interesting and important indication
But it's going to take time to build, frankly
