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SCHEDULE 14A
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Proxy
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AMYLIN
PHARMACEUTICALS, INC.
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FINAL TRANSCRIPT
Conference Call Transcript
AMLN -
Amylin Pharmaceuticals, Inc. at Cowen and Company Healthcare Conference
Safe Harbor Statement
This presentation contains
forward-looking statements about Amylin.
Our actual results could differ materially from those discussed due to a
number of factors, including: BYETTA and/or SYMLIN may be affected by
competition, safety or other issues; clinical trials not being completed in a
timely manner or achieving the intended clinical endpoints; NDAs or sNDAs not
being submitted in a timely manner or receiving regulatory approval; expense
reductions not being as large as we expect; our label update not being
finalized in a timely manner; or manufacturing and supply issues. The pace of market acceptance and rate of
patient adherence may also affect the potential for BYETTA and/or SYMLIN. These and other risks and uncertainties are
described more fully in Amylins most recently filed Form 10-K. Amylin disclaims any obligation to update
these forward-looking statements.
ADDITIONAL
INFORMATION AND WHERE TO FIND IT
This release may be deemed to
be solicitation material in respect of the matters to be considered at the 2009
annual meeting of shareholders. Amylin
will be filing a proxy statement with the Securities and Exchange Commission
(SEC).
INVESTORS AND SECURITYHOLDERS ARE URGED TO READ THE PROXY
STATEMENT AND ANY OTHER RELEVANT DOCUMENTS FILED OR THAT WILL BE FILED WITH THE
SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION.
Investors and securityholders
will be able to receive the proxy statement and other relevant documents free
of charge at the SECs web site, www.sec.gov or from Amylin Investor Relations
at 9360 Towne Centre Drive, San Diego, California 92121.
PARTICIPANTS
IN SOLICITATION
Amylin and its directors and
executive officers and other members of management and employees may be deemed
to be participants in the solicitation of proxies in respect of the matters to
be considered at the 2009 annual meeting of shareholders. Information regarding the interests of
Amylins directors and executive officers in the proxy contest will be included
in Amylins definitive proxy statement.
Mar 17, 2009 / 8:00AM
ET, AMLN - Amylin Pharmaceuticals, Inc. at Cowen and Company Healthcare
Conference
EVENT DATE/TIME: MAR 17, 2009 / 8:00AM ET
CORPORATE PARTICIPANTS
Dan Bradbury
Amylin
Pharmaceuticals, Inc. - President & CEO
CONFERENCE CALL PARTICIPANTS
Phil Nadeau
Cowen and
Company - Analyst
PRESENTATION
Phil Nadeau
- Cowen and
Company - Analyst
Good
morning and welcome once again to Cowen and Companys 29th Annual Healthcare
Conference. Im Phil Nadeau, a biotech analyst here at Cowen, and its my
pleasure to introduce the first presenting company this morning, Amylin Pharmaceuticals.
These
are exciting times for Amylin with two drugs on the market and LAR on the cusp
of being filed with the FDA. CEO, Dan Bradbury, will give about a 20- to
25-minute talk in this room. There may be questions here time for questions
here and, if not, there is a breakout immediately following in the Tufts Room,
which is right around the corner. Dan?
Dan Bradbury
- Amylin
Pharmaceuticals, Inc. - President & CEO
Thanks,
Phil. Good morning and top of the morning to you. Happy St. Patricks Day here
in Boston and may the luck of the Irish be with you in the markets today.
So
before I start just a reminder that most of the comments that I will be making
will be about future plans for our organization and I intend to make a number
of forward-looking statements, so please consult your SEC filings for a full
description of our risks.
2009
is a year in which we are confident of our five-point plan that we have put in
place to create value. That plan revolves around BYETTA, exenatide once weekly,
SYMLIN, our obesity franchise, and improving our operating results.
With
BYETTA we have the opportunity to leverage the inclusion at the end of last
year of BYETTA in the ADA/EASD treatment guidelines and capitalize on the
shifting patterns of treatment in the diabetes marketplace. We also had the
opportunity to gain the approval for a new indication for BYETTA for
monotherapy and at the same time get the label update as well to reflect new
safety information.
Our
number development goal in 2009 is to submit exenatide once weekly. In doing
so, we will be leveraging the experience that we have had over the last four
years with BYETTA. Accompanying that we will be executing the DURATION studies.
These are studies designed to demonstrate that exenatide once weekly is
superior to most other treatments for the treatment of diabetes, and indeed
will enable us to position exenatide once weekly for a successful launch.
SYMLIN
in 2008 grew by more than 30% and we intend to continue that growth rate in
2009.
With
our obesity franchise we have two major clinical studies that are being
completed. The first of those will complete in the third quarter, the second in
the fourth quarter. At that time we will finalize our development strategy at
the same time as finalizing a funding strategy for late-stage development in
obesity.
And
as we progress towards our corporate goal of being cash flow positive by the
end operating cash flow positive by the end of 2010, we will be focused on
reducing our expenses and overall improving our operating results.
These
five areas of focus in 2009 will provide us the opportunity to create
significant value for patients, physicians, payers, and our shareholders.
Let
me start off by talking about BYETTA. BYETTA is the first and only FDA-approved
GLP-1 agonist and the only medicine today that addresses the significant unmet
medical needs in type 2 diabetes by providing powerful sustained A1C control
with weight loss. This is supported by a low risk of hypoglycemia. Its in its
fourth year in the market with over one million patients being treated. As I
mentioned earlier, it was recently included in the American Diabetes
Association treatment guidelines.
We
are working to better understand the relationship between BYETTA and
pancreatitis reported in some spontaneously reported cases. In keeping with our
focus on patient safety, we have continued to pursue drug safety program that
includes thorough investigation of individual spontaneous events along with
clinical and epidemiological studies.
Now
within the detection limits of an initial epidemiology study we have not
observed an increased incidence of pancreatitis associated with BYETTA compared
to other treatments for diabetes, thus a definitive causal relationship between
BYETTA and pancreatitis has not been proven. This initial epidemiology study
has just been published in the clinical medical research outcomes journal* last
week.
The
FDA is continuing with its review of the regulatory application for monotherapy
and several other prescribing information updates, including revision of safety
language. It is likely that this review will not be complete in this quarter.
However, we remain confident that it will happen in the near future and
continue to be encouraged with our interactions with the FDA and with their
review of the data that we have provided.
We
continue to work with our collaborator, Eli Lilly and Company, to improve the
effectiveness and the efficiency of our collaboration together.
Now I
spoke to you about the positive attributes of BYETTA, powerful glucose control
with weight loss, and let me tell you why that is important. 80% of people with
type 2 diabetes are overweight, obesity increases the risks of cardiovascular
disease 44% in people with type 2 diabetes, and cardiovascular death accounts
for at least 75% of all deaths among people with diabetes.
In
fact, last October a study published in the
Diabetologia
,
the journal for the European Association for the Study of Diabetes,
encompassing over 60,000 patients found that the risk of coronary heart disease
and death are significantly increased in the overweight and to an even greater
extent in obese patients with type 2 diabetes compared with those who just have
type 2 diabetes and are non-obese. In fact, their risk of death increases 71%
over a six-year period.
These
results provide prospective evidence demonstrating that weight gain is
associated with increased cardiovascular risk in type 2 diabetes and therefore
weight effects are critical consideration when selecting treatment for type 2
diabetes. Now this
Diabetologia
paper came out last year after the publication of a number of landmark studies
at the American Diabetes Association meeting last June.
At
that meeting the UKPDS 10-year follow-up, the ACCORD study, the ADVANCE study,
and the VADT study were reported. These studies showed that treating patients
earlier and lowering blood glucose without weight gain was critical to improved
outcomes. In fact, the ADA and the EASD are considering these data as well and
in fact that led to the change in the EASD/ADA guidelines, which included the
inclusion of BYETTA in those guidelines.
I
will point out that BYETTA was actually the only new medication added to the
ADA/EASD guidelines in 2008. Indeed BYETTA was noted as the treatment of choice
for patients for whom weight management and hypoglycemia are a concern. Now
that represents somewhere around 80% to 90% of patients with type 2 diabetes,
so both Amylins products, BYETTA and SYMLIN, are unique in that they provide
powerful glucose control and weight loss. This positions them well in a market
which is currently growing at epidemic proportions is at epidemic proportions
and is growing dramatically.
Moving
on to exenatide once weekly. Once approved, exenatide once weekly could be the
first once weekly therapy to treat type 2 diabetes with unprecedented efficacy
and curable glucose control, sustained weight loss, and improved tolerability
relative to BYETTA. Exenatide once weekly has a unique and compelling value
proposition. It offers patients, payers, and physicians the long-term adherence
solution needed to ensure improved health outcome for this disease.
As
you can see in this slide, the A1C decline of 2% that we saw in the pivotal
DURATION-1 study is unprecedented for this type of study. 74% of all patients
achieved the ADA guideline endpoint of 7% or less. Average weight loss over 30
weeks was 9.5 pounds and there were improvements in CV events sorry, CV risk
factors including blood pressure, cholesterol, and triglycerides. There was no
increase in
*
Journal title is
Current Medical Research and Opinion
hypoglycemia
when exenatide once weekly was used with metformin or a thiazolidinediones and
overall tolerability is improved compared with BYETTA. In market research studies it isnt
surprising to find that doctors are excited by these results and are eager to
bring this to have this therapy as an option. Bringing exenatide once weekly
to the market is our number one development priority.
I
talked to you about the reasons why exenatide once weekly is so important, now
I will update you on the status of the NDA filing. We had a pre-NDA meeting
with the FDA in the second quarter of 2008. As a result of that meeting, we
believe that the DURATION-1 study alone provides the necessary pivotal safety
and efficacy data for the submission. We confirmed with the FDA at that meeting
that we would be referencing the entire exenatide safety database as part of
the application.
FDA
feedback received in the fourth quarter last year on the DURATION-1 extension
study is appropriate as the basis for demonstrating comparability between
development scale material and commercial scale material manufactured at our
new manufacturing facility in Ohio means that we will have extension data to
demonstrate this comparability by the end of this quarter. I should say at the
end of this month.
Additionally,
the FDA published in December guidance on requirements for all IND holders
of anti-diabetic therapies to show that their compounds do not increase the
risk of cardiovascular events. We received feedback from the FDA regarding this
latest guidance on assessing the risk of cardiovascular risk for exenatide and
we were told to proceed with the meta analysis of the controlled clinical trials
in the exenatide safety database to evaluate the cardiovascular risk for
exenatide once weekly.
We
will be providing specific details regarding this analysis in the coming weeks,
but just to say at this point the preliminary analysis of this database, which
includes several thousand patients, has already been completed and indicates
that there is no increased risk of cardiovascular events associated with
exenatide treatment. We are in the process of finalizing this analysis and the
comparability data and remain on track to submit the exenatide NDA exenatide
once weekly NDA by the end of the second quarter of 2009.
Now I
will share with you the progress on the head-to-head exenatide development
program to drive rapid adoption at launch. This development program, if you
think of it in terms of the context of the environment into which exenatide
once weekly will be launching or is prescient, think about all that you have
read recently about the need for clinical, comparative data. This program
compares exenatide once weekly against alternative therapeutic choices,
employing study designs to demonstrate superiority.
The
objective is to launch and demonstrate the transformational nature of exenatide
once weekly. These trials are on track. DURATION-2 is a head-to-head study of
exenatide once weekly against a thiazolidinedione, or DPP-4 inhibitor, on a
background of metformin therapy. Results from this study will report in the
second quarter of this year.
DURATION-3
is a head-to-head study of exenatide once weekly against insulin glargine on a
background of oral agent therapy and the results are expected in the third
quarter. The DURATION-4 is a head-to-head study of stand-alone therapies
exenatide once weekly against either metformin, a thiazolidinedione, or a DPP-4
inhibitor. It was initiated last quarter and is expected to be completed next
year.
Now
also on this slide, please note a very important study is also planned to
initiate this year; that is the CV outcomes study. We have seen very positive
effects on cardiovascular surrogate outcomes with exenatide; that is blood
pressure, triglycerides, and lipids. We have engaged a steering committee
composed of outside experts to assist us in designing a robust cardiovascular
outcomes study.
The
study will give us the opportunity to demonstrate the effects of exenatide once
weekly on cardiovascular outcomes as well as other endpoints of interest to our
stakeholders. The design will be reviewed with the FDA with plans to initiate
patient enrollment in the second half of this year with interim data in 2012
and final data in 2016.
As
you can see by looking at this cadre of studies, we are positioning exenatide
once weekly for near- and long-term success by addressing the possible entrants
of competitors. We believe that these studies will enable exenatide once weekly
to dominate the diabetes marketplace in the future.
In
summary, exenatide once weekly is a product that we believe will transform
diabetes therapy. It will be the first once weekly therapy for diabetes ever.
It has transformational efficacy supported by the BYETTA safety profile. The
FDA path for regulatory submission is established. We have a manufacturing
facility that is operational. We have an aggressive clinical plan to ensure
rapid adoption and we believe exenatide once weekly offers a truly unique value
proposition for patients, physicians, and for payers. And as I mentioned
earlier, we remain on track for submission by the end of the first half of this
year.
Now I
would like to move on to talk to you about SYMLIN, our other product for use in
people with type 1 or type 2 diabetes who use mealtime insulin. SYMLIN is a
synthetic analogue of human amylin, a naturally occurring hormone that is made
in the beta cells of the pancreas, the same cells that make insulin. SYMLIN is
the first and only FDA approved amylin mimic and has been on the market for
nearly 4 years. It addresses key unmet needs of insulin therapy by reducing
blood glucose fluctuations, improving glucose control, and reducing body weight
for people with type 1 and type 2 diabetes who use insulin, mealtime insulin.
SYMLIN
had revenue of $86.8 million in 2008, which represented a 33% growth rate over
2007. We expect to see similar growth in 2009 as a result of our very focused
physician targeting and patient selection, as well as managing expectations and
supporting patients to increased persistence through a high-touch, high-support
marketing strategy.
Another
area for value creation in Amylin is our obesity program. Our obesity program
leverages our experience with diabetes and peptide and protein science, and as
a result we are able to develop product candidates utilizing a risk advantaged
development strategy that focuses on peptide and protein mimics of human
hormones. Overall, our pipeline is built on combining multiple hormones with
additive/synergistic effects to produce an integrated neurohormonal therapy for
obesity, something we call it INTO, optimizing native hormones through peptide
engineering to generate analogues with superior biological and pharmaceutical
attributes and incorporating sustained-release or alternative delivery
technologies to enhance patient convenience and adherence. Together these
approaches offer the potential for safe and effective weight loss, approaching
or exceeding double-digit percentage and significant improvements in ancillary
medical conditions.
Now
to focus on our most advanced opportunity, obesity that is an obesity
combination of analogues of the human hormones amylin and leptin. In our proof-of-concept
study, Phase II proof-of-concept study we showed that when we used the amylin
and leptin analogues, that is pramlintide and metreleptin, that after 24 weeks
there was 12.7% body weight reduction.
In
the third quarter of this year we will report out a fully-enrolled study, Phase
IIb study which has over 600 patients in it and is a multi-arm study which is
looking at different dosing combinations of pramlintide and metreleptin. This
study has the promise to meet the unmet needs of safe and highly effective
weight loss therapy, and we are looking forward and excited to seeing the
results of this study in the third quarter.
Our
other opportunity is in our pipeline, is our second-generation amylin mimic
called davalintide. This is an amylin mimic which has been optimized for weight
loss. This product is in Phase II and the Phase II study will report out in the
fourth quarter of this year.
Now I
would emphasize that we are keeping close control on all our costs when it
comes to our obesity pipeline and are actively managing our R&D expenses.
Additionally, we are pursuing options to offset R&D expenses with our
obesity and early-stage programs through potential partnerships or project
financings. We anticipate having more information to report to you about our
obesity strategy by the end of this year.
Now
moving onto our fifth and final area of value creation, I will highlight our
progress towards improving our operating results. Our key objective as a
company is to be cash flow positive from operations by the end of 2010. In 2008
our total revenues were $840 million with product revenues net product
revenues of $765 million and we had a non-GAAP operating loss of approximately
$120 million.
For
2009 our goal is to reduce that non-GAAP operating loss to between $75 million
and $100 million. We will achieve that by continuing to focus on reducing our
overall operating expense. Our GAAP operating expense is estimated to be
reduced over 2008 by over $100 million. And we expect to finish 2009 with a cash
balance of approximately $600 million, down a couple of hundred million from
the end of 2008 where it was $817 million. Additionally, I would point out that
we continue to have access to a loan from Eli Lilly and Company of $165
million.
As
you can see, we are continuing to be very focused on managing our expenses and
indeed focused on managing our cash flow from operations. And we are well
capitalized and continue to take deliberate action to manage expense.
On
this slide you can see that we have before us a number of regulatory and
development milestones representing key near-term value creation opportunities
that will position us for long-term success. The FDA is continuing to review
the regulatory application for monotherapy for BYETTA and several other
prescribing information updates. That includes the revision of the safety
language.
As I
mentioned, it is likely that that will not be complete in the first quarter.
However, we remain confident that it will happen in the near future and we
continue to be encouraged by our interactions with the agency and their review
of the data that we have provided.
In
the second quarter we will report the DURATION-2 study and the DURATION-3 study
will be available the following quarter. Also in the third quarter will be the
results of the pramlintide/metreleptin study, Phase IIb study, and then we
expect the results from the Phase II davalintide
study
in the fourth quarter. Finally, we will finalize our obesity funding and
development strategy which includes assessing partnership opportunities to
offset the cost of advancing these compounds into Phase III by the end of the
year.
This
is an action-packed year for Amylin with numerous events that we believe will
create significant value for shareholders. So to finalize, in 2009 we are
confident in our five-point plan for value creation and remain focused on
execution. Growing BYETTA, gaining approval of the monotherapy label,
submitting exenatide once weekly, continuing to grow SYMLIN, completing the
clinical work in our obesity franchise, and focusing intently on managing our
operating expense to improve our operating costs are our five goals for 2009.
These
five areas we believe will provide significant opportunity to create value for
patients, for physicians, for payers, and our shareholders. Thank you for your
attention this morning. I very much appreciate it.
Phil,
do we have some time for questions? Okay, absolutely. Okay, Phil?
QUESTION AND ANSWER
Phil Nadeau
- Cowen and
Company - Analyst
(inaudible
question - microphone inaccessible) completed within the next few weeks. What
is the (inaudible) strategy (inaudible) and if so what type of data will you
announce? And maybe give us an idea of how to interpret that?
Dan Bradbury
- Amylin
Pharmaceuticals, Inc. - President & CEO
I
think the key thing will be our internal assessment of whether or not that
comparability data meets the requirements as laid out to us in correspondence
from the FDA. And I think you can be confident if we are also continue to announce
that we are planning to submit the NDA that we believe that it will have met
the end point. Sir?
Unidentified
Audience Member
(inaudible
question - microphone inaccessible)
Dan Bradbury
-
Amylin Pharmaceuticals, Inc. - President &
CEO
BYETTA
and exenatide once weekly are not being discussed on the upcoming panel to our
knowledge. We have had no indication from the FDA that they intend to do that.
I
think to some extent what I believe you are reflecting is the fact the FDA is
extremely busy at this point in time. There is a lot going on in the division
and that certainly to some extent is holding things back from our point of
view. We are seeing that its taking longer to turn things around and that is I
dont think inconsistent with what we have been seeing by other companies as
well.
Unidentified Audience Member
(inaudible question - microphone
inaccessible)
Dan Bradbury
-
Amylin Pharmaceuticals, Inc. - President &
CEO
No,
as I indicated, I dont expect to see it in the first quarter now. I expect it
to be I would hope soon thereafter. However, its very difficult to predict
at this point in time.
Any
further questions? If not, then thanks very much and I appreciate your
attendance here this morning. Thank you.
QUESTION AND ANSWER BREAKOUT
Unidentified
Audience Member
(inaudible
question - microphone inaccessible)
Dan Bradbury
Amylin Pharmaceuticals, Inc. - President &
CEO
So
that is a great question. Just to repeat the question just in case we are being
webcast, so the question was will we know from the FDA panel what the sentiment
is with regards to the label for BYETTA on pancreatitis?
I
dont expect so. I mean we have had no indication from the FDA that there is
going to be any discussion with regards to exenatide data at the panel meeting.
We havent been asked to attend that panel. There will, of course, be Amylin
people watching what is going on but we havent been asked to formally attend
the meeting.
So as
far as I am aware the meeting, there is two days. One is on saxagliptin and
then the second day is on liraglutide. And the agenda for those two days hasnt
yet been set or, sorry, should not say, has not yet been published.
Unidentified Audience Member
(inaudible question - microphone
inaccessible)
Dan Bradbury
- Amylin
Pharmaceuticals, Inc. - President & CEO
You
know, I guess what I would say to you there is that the FDA has in the past put
products together as a class review, but that is not always the case. And in
fact, more often than not they actually are as focused on the individual
products that are being reviewed.
The
reason for that is I think they are quite careful about not to make assumptions
with regards to class effects unless there clearly is a direct mechanistic
association for an effect. In particular and I think one of the things that
people need to be very, very clear about when thinking about exenatide versus
any other GLP-1 compound is that the weight of evidence in terms of safety in
particular is significantly greater.
This
product has been on the market for over four years. Over one million people
have used it. It also is a very different chemical entity from any of the
others that are currently in development. So as I said at a previous investor
presentation the inconvenient truth is that not all GLP-1s are created equal
and perhaps that is a good way to think about it because I think that is the
way the FDA thinks about it.
Unidentified Audience Member
(Inaudible question - microphone
inaccessible)
Dan Bradbury
- Amylin
Pharmaceuticals, Inc. - President & CEO
Yes.
If you dont mind, I will repeat your question. So the question was you have
said that you would be able to use the exenatide entire safety database
including the BYETTA patients and that is what the FDA confirmed. And that is
right, the FDA did confirm. They told us to proceed on an analysis meta
analysis based on the controlled clinical studies that have been done for both
BYETTA and exenatide once weekly.
Unidentified Audience Member
(Inaudible question - microphone
inaccessible)
Dan Bradbury
- Amylin
Pharmaceuticals, Inc. - President & CEO
Last
quarter after they issued the guidance. We actually connected with them
directly to confirm that was the appropriate way to go forward. Sir?
Unidentified
Audience Member
(inaudible
question - microphone inaccessible)
Dan Bradbury
-
Amylin Pharmaceuticals, Inc. - President &
CEO
Yes,
165 million. Yes.
Unidentified
Audience Member
(inaudible question - microphone
inaccessible)
Dan Bradbury
- Amylin
Pharmaceuticals, Inc. - President & CEO
The
loan, the Lilly loan the collateral for that loan is the facility that we
have built in Ohio, the manufacturing facility.
Unidentified Audience Member
(Inaudible question - microphone
inaccessible)
Dan Bradbury
-
Amylin Pharmaceuticals, Inc. - President &
CEO
So
the question is what happens to the Lilly loan if we get acquired by another
company? I think in that case its the same thing would apply to the
acquirer. The acquirer has the same obligations as we would to Lilly unless
Lilly at that time then triggers the change of control provision within our
collaboration contract, which may or may not lead to the change in ownership of
exenatide.
I
think I would refer you back to our collaboration agreement and the change of
control provision because that actually has greater that has more importance
here than the loan agreement.
Unidentified Audience Member
(Inaudible question - microphone
inaccessible)
Dan Bradbury
-
Amylin Pharmaceuticals, Inc. - President &
CEO
No. They
are distinct.
Unidentified
Audience Member
(Inaudible question - microphone
inaccessible)
Dan Bradbury
-
Amylin Pharmaceuticals, Inc. - President &
CEO
You
are welcome.
Unidentified
Audience Member
(Inaudible question - microphone
inaccessible)
Dan Bradbury
-
Amylin Pharmaceuticals, Inc. - President &
CEO
Absolutely.
So the question was about the statement about enhancing the effectiveness and
the efficiency of the sales and marketing efforts with Lilly. We have been
working consistently with Lilly over the years to refine the way that we work
together on both the sales and marketing front. Most recently at Amylin we
appointed a new head of commercial, our senior vice president of Sales and
Marketing, Vince Mihalik.
He
actually joined us from Eli Lilly and Company, and Vince and his counterpart in
Lilly Enrique Conterno are working together to improve the way that our sales
forces interact as well as to improve the efficiency of the way that our
marketing departments work together.
Unidentified Audience Member
(inaudible question - microphone
inaccessible)
Dan Bradbury
-
Amylin Pharmaceuticals, Inc. - President &
CEO
So
the question was about the restructuring and could I talk about the sales
forces and the effect on the sales forces. Actually the restructuring that we
undertook last year was a 25% reduction in the workforce in our San Diego
operations. It mainly affected our R&D infrastructure and operations group.
It didnt affect, actually, our commercial group. So there was no reduction in
the headcount in our sales force last year as a result of the restructuring.
Unidentified Audience Member
(inaudible question - microphone
inaccessible)
Dan Bradbury
-
Amylin Pharmaceuticals, Inc. - President &
CEO
That is
a great question. So currently there are over 1,600 people in the field who are
responsible for the sales and marketing of BYETTA.
Unidentified Audience Member
(Inaudible question - microphone
inaccessible)
Dan Bradbury
-
Amylin Pharmaceuticals, Inc. - President &
CEO
That
is a great question, Kevin. So the question was could I comment on sensitivity
to sales force size on the marketing and sales of BYETTA. That is a great
question we are actually looking at that at this time. Previously work that we
did demonstrated that there would be a benefit to increasing the field force.
Last year we increased our field force by 65 people and we matched Lillys
field forces.
Since
that time I think its fair to say that there has been an evolution in the
diabetes marketplace. One of the things that we are saying is that major brands
are pretty flat. You see Lantus is pretty flat. You see Januvia is pretty flat
and responsiveness to sales force size doesnt seem to be as great as it used
to be. And that is, I think, pretty indicative of what is going on in chronic
disease markets in general.
So
certainly one of the things that we are looking at is whether or not there
should be a change in our philosophy there, but we havent made any decisions
at this time.
Unidentified Audience Member
(inaudible question - microphone
inaccessible)
Dan Bradbury
-
Amylin Pharmaceuticals, Inc. - President &
CEO
SYMLIN
certainly is for a smaller audience than for BYETTA. So with SYMLIN we really
focus on the diabetes specialists, the endocrinologists and what we like to
call the endo-mimetics. That is physicians who are primary care/internal
medicine physicians who see a large proportion of diabetes patients and
generally speaking have support for diabetes patients within their clinics. And
that is a significantly smaller group of physicians.
Any
additional questions? No? Oh, sorry.
Unidentified
Audience Member
(inaudible question - microphone
inaccessible)
Dan Bradbury
-
Amylin Pharmaceuticals, Inc. - President &
CEO
That
is a great question. I think its fair to say that there were some very
significant misperceptions created at the time of the FDA alert that occurred
last year. We have continued to try and ensure that we are able to educate
physicians with the latest information we have. And indeed our primary goal at
the time of the FDA alert last year was to ensure that we fully educated
physicians as widely as possible about the totality of the knowledge that we
have.
That
is totally consistent with our approach as a company of being focused on
patient safety. And that approach has been manifest further by our additional
investment in finding out more about pancreatitis in diabetes as well as
investing in significantly in clinical and in epidemiological studies, which we
have now shared with the FDA. The dialogue with the FDA is ongoing at this
point with regards to their thoughts about how to adjust our label.
What
I would say to you is that one of the things I have been most pleased about in
our interactions with the FDA is how open they have been to receiving new
information. Its clear that we have a consistent goal together and that is to
get the appropriate language included in our label to reflect the totality of
the data that we know with regards to pancreatitis. It is clear at this point
in time that as a result of the epidemiologic studies its not possible to make
any conclusion with regards to any causal relationship between BYETTA and
pancreatitis.
Unidentified Audience Member
(inaudible question - microphone
inaccessible)
Dan Bradbury
-
Amylin Pharmaceuticals, Inc. - President &
CEO
So
the update with regards to the monotherapy indication and the update with
regards to safety, these two are now being concurrently reviewed at the FDA and
so they are being linked together. And so what we originally thought at the
beginning of this quarter was that we would be completed with this work by the
end of the quarter. Unfortunately, that is not how it seems its going to be.
Things are taking a little bit longer with the Agency.
I
must admit, from my point of view, I would prefer them to take the time, review
the data completely, and ensure that we get the correct language and labeling
at the time of the approval of the monotherapy indication as well as the update
with regards to safety language.
Unidentified Audience Member
(inaudible question - microphone
inaccessible)
Dan Bradbury
-
Amylin Pharmaceuticals, Inc. - President &
CEO
Well,
I think what is going on is that there are a number of things that are being
looked at and I think its just easier to do. Instead of doing one label update
one week and then doing another label update the next week and then another one
the following week, the Agency is looking at them altogether. Kevin?
Unidentified Audience
Member
(inaudible
question - microphone inaccessible)
Dan Bradbury
-
Amylin Pharmaceuticals, Inc. - President &
CEO
They
are not actually counted as biologics. They are reviewed by the CDER and not CBER.
Unidentified Audience Member
(inaudible question - microphone
inaccessible)
Dan Bradbury
-
Amylin Pharmaceuticals, Inc. - President &
CEO
Right.
The IP packages on these products are extremely strong. We have patents on
BYETTA going out through 2016 and on pramlinitide through 2018 on the initial
patents. And then beyond that additional delivery patents and formulation
patents beyond that. Exenatide once weekly has a unique number of patents
related to not only the product itself, the way its made, the microspheres,
but also the manufacturing of the product.
I
would say that my view on the patents is that whilst I believe with the patents
are extremely important, I would also say that the probability of somebody
actually building a new facility like we have just done for exenatide once weekly
is extremely low just given the amount of money we just had to put into it.
Unidentified Audience Member
(inaudible question - microphone
inaccessible)
Dan Bradbury
-
Amylin Pharmaceuticals, Inc. - President &
CEO
I
dont think anything is kind of run of the mill I guess, but I appreciate the
characterization. BYETTA is a peptide; its a 39 amino acid peptide. Its not
that simple to make; there arent that many places in the world that can make
it. But from a patent standpoint, we have very strong patents in place to
protect it and we believe that those patents will protect it at least through
2016.
Unidentified Audience Member
(inaudible question - microphone
inaccessible)
Dan Bradbury
-
Amylin Pharmaceuticals, Inc. - President &
CEO
So
price increases over the last few years, we have been reasonably aggressive
with regards to our price increases over the last few years as we have looked
to position the products for value in the marketplace and establish them
relative to other products.
What
I would say there is that I do think we are entering into an even more
challenging period with regards to pricing. But at the end of the day I think
it all comes down to what is the value that you actually bring to the patient
and to the health care system. I would really take your attention to the
program that we have initiated for exenatide once weekly.
The
whole clinical program is deliberately designed to demonstrate clinical
comparative data and to enable us to be able to be very quantitative with respect
to the value proposition that exenatide once weekly brings relative to the
existing therapies. And that I believe will help us significantly in our
pricing strategy as well.
Unidentified Audience Member
(inaudible question - microphone
inaccessible)
Dan Bradbury
-
Amylin Pharmaceuticals, Inc. - President &
CEO
Its
a little bit difficult to say how we will compete when there havent even been
approved yet, right? But just to say that I mentioned it earlier that not all
GLP-1s are alike and there are significant differences between BYETTA and the
GLP-1 products. I think its not clear what all of those differences are at
this time, but more will become, I think, available to us over the coming
couple of weeks actually.
And
then thereafter we will soon see what is some of the differences. But one of
the two key differences that I think we know today is that firstly our
experience with regards to BYETTA is significantly greater than any new
chemical entity coming into the market place. And indeed our reimbursement is
tremendous. We have over 85% reimbursement at Tier 2 and that is something that
any new entrant into the marketplace is going to take some time to address.
So we
feel very confident with regards to the competitive profile of BYETTA and of
course exenatide once weekly leverages those competitive edges that we already
have in an even more convenient, more efficacious form. So I think it gives us
a strong opportunity for very significant market dominance going forward.
Unidentified Audience Member
(inaudible question - microphone
inaccessible)
Dan Bradbury
-
Amylin Pharmaceuticals, Inc. - President &
CEO
As is
just mentioned earlier, monotherapy approval during my presentation I
mentioned that it seems it would be unlikely this quarter now, mainly as a
result of the Agency taking more time to review data that we have given to
them. We expect we are pleased with the way that the Agency is taking the
time to review the data. We expect it to be forthcoming fairly soon in the
second quarter, but that is purely an estimate. I will just say that is purely
an estimate.
Okay.
All right. Thanks very much, everybody, for questions. I appreciate it. Good to
see old friends today and top of the morning to you.
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