Michael Partridge
- Vice President-Investor Relations
Good evening, everyone. This is Michael Partridge, Head of
Investor Relations for Vertex Pharmaceuticals. Welcome to our
Second Quarter 2015 Financial Results Conference Call. At this
time, all participants are in a listen-only mode. Later, we will
open the line for questions. As a reminder, this conference call is
being recorded and a replay will be available following the
conclusion of tonight's call on our website.
Earlier in July, we announced the approval of ORKAMBI and many
of you joined for that call. Tonight, we will be focused on second
quarter performance and our execution against our corporate
strategy. Joining me on tonight's call are Dr. Jeff Leiden,
Chairman and CEO; Stuart Arbuckle, Chief Commercial Officer; and
Ian Smith, Chief Financial Officer. Jeff Chodakewitz, our Chief
Medical Officer is travelling and is not with us tonight.
Our agenda tonight is as follows. Jeff will begin by discussing
key priorities for our business. Stuart will review the second
quarter performance of KALYDECO and make a few comments on the
ORKAMBI launch. And to close, Ian will review the second quarter
2015 financial results and update our 2015 guidance. You can access
the webcast slides by going to the Events section of the Investor
Relations page on our website.
I will remind you that we will make forward-looking statements
on this conference call. These statements are subject to the risks
and uncertainties discussed in detail in today's press release and
our 10-K, which has been (01:32) without limitation, those
regarding the ongoing development and potential commercialization
of ORKAMBI, those about Vertex's other cystic fibrosis programs,
and Vertex's future financial performance are based on management's
current assumptions. Actual outcomes and events could differ
materially.
Information regarding our use of GAAP and non-GAAP financial
measures and a reconciliation of GAAP to non-GAAP is available on
our second quarter 2015 financial results press release. I would
also refer you to slide four of tonight's webcast.
I will now turn the call over to Dr. Jeff Leiden.
Jeffrey M. Leiden
- Chairman, President & Chief Executive Officer
Thanks, Michael. Good evening, everyone. The approval of ORKAMBI
on July 2 was an important milestone in our shared journey with the
cystic fibrosis community. ORKAMBI is the first FDA approved
medicine to treat the underlying cause of CF for the approximately
8,500 people in the U.S., 12 years and older, with two copies of
the F508del mutation. This is a big step forward toward our
long-term vision of helping more people with CF. We feel very
fortunate to be part of the CF community and we appreciate all of
the positive feedback we have received and continue to receive from
patients, caregivers, healthcare providers and the broader CF
community.
At the beginning of this year, we outlined three strategic
priorities that will allow Vertex to continue to deliver on our
vision to make new transformative medicines available to patients
globally. Let me briefly review our progress toward meeting those
goals.
First, through both geographic and label expansion, we have
continued to grow the number of patients treated with KALYDECO,
resulting in strong revenue growth. With the ORKAMBI approval and
launch in the U.S., we have an even greater opportunity to treat
more patients, resulting in additional revenue growth.
Second, we know that there is still much more to do. We continue
to make significant investment into multiple programs to create
more CF medicines that may enable us to treat even more patients
and to improve the benefit for the patients we treat. All four
studies included in the VX-661 plus ivacaftor pivotal Phase 3
development program are initiated and we also remain on track to
bring a next generation CFTR corrector into the clinic by the end
of 2015.
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