EXHIBIT 99.2
EYETECH PHARMACEUTICALS
Moderator: David Guyer
May 26, 2005
7:30 am CT
Operator: Good morning. My name is (Cynthia) and I will be your conference
facilitator today. At this time I would like to welcome everyone
to the Eyetech Pharmaceuticals conference call. All lines have
been placed on mute to prevent any background noise.
After the speaker's remarks, there will be a question and answer
period. To allow everyone the opportunity to ask a question
during this time, please limit yourself to one question. If time
permits, all questions will be taken.
If you would like to ask a question, simply press star then the
number 1 on your telephone keypad. If you would like to withdraw
your question, press star then the number 2 on your telephone
keypad. At this time I would like to turn the conference over to
(Susan Silao), Associate Investor Relations. Please go ahead
ma'am.
(Susan Silao): Thank you (Cynthia). Good morning and thanks
for joining ustoday. This conference call is being
recorded and will be available through
replay starting at 11:30 am Eastern Time today and running
until 11:30 pm Eastern Time on Wednesday June 1, 2005.
The replay number for today's call are 800-642-1687 within the US
or 706-645-9291 internationally. The passcode to listen to the
replay will be 6644652. In addition, this call is available via
Web cast by accessing the Investor Relations Section of our
corporate Website at www.eyetech.com. An
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archive version of the Web cast will be available at the same
location through June 1, 2005.
And now I will turn the call over to Chris Smith, the Executive
Director of Public Relations and Corporate Communications at
Eyetech.
Chris Smith: Thanks (Sue). Good morning everyone. Representing Eyetech today,
we have the company's Chief Executive Officer, Dr. David Guyer.
Also available for questions are Glenn Sblendorio, the company's
Chief Financial Officer, Dr. Anthony Adamis, Chief Scientific
Officer and Paul Chaney, Chief Operating Officer.
We've invited two distinguished experts to join us today. They
are Dr. Donald J. D'Amico, Professor of Ophthalmology at the
Massachusetts Eye and Ear Infirmary at the Harvard Medical School
and Dr. Carmen A. Puliafito, MBA, Professor and Chair of
Ophthalmology at the Bascom Palmer Eye Institute at the
University of Miami School of Medicine.
Both doctors have extensive experience with anti-VEGF therapy and
we encourage you to ask them questions during the Q&A.
The views and positions expressed by Drs. D'Amico and Puliafito
are not necessarily the views and decisions of Eyetech. Both
experts have served as medical consultants to Eyetech and other
pharmaceutical and biotechnology companies. Neither expert has an
equity position in Eyetech.
Before we get started, we'd like to remind you that this
conference call contains forward-looking statements regarding
future events and expectations including without limitation,
growth opportunities, technology and product candidate
development, statements regarding anticipated financial results
in
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calendar year 2005 and other statements that refer to Eyetech's
plans, prospects, expectations, strategies, intentions and
beliefs.
These forward-looking statements are based on the information
available to Eyetech today. The company assumes no obligation to
update these statements as circumstances change.
For additional information on the risks that may cause actual
results to differ from expectations, please see the risk factor
section of our Q1 '05 quarterly report on form 10-Q on file with
the SEC.
I will now turn the call over to Dr. David Guyer, Chief Executive
Officer of Eyetech.
David Guyer: Good morning everyone. We have three messages today.
First, we remain very confident in Macugen as a major medical
breakthrough with significant commercial value now and in the
future. Today I will share a more detailed view of the various
market opportunities and Eyetech and Pfizer's planned expansion
of the Macugen franchise including timelines.
Two, the jury is still out about the investigational antibody
fragment from Genentech. The interim one-year results announced
are not complete. We will share our assessment of what
information is missing and what questions remain unanswered.
Three, we are eager to talk to you today and as news in this
market continues to unfold, we are committed to maintaining a
dialogue.
Now why are we so confident in the commercial success of Macugen?
First, the neovascular AMD market is large, growing and
underserved. We estimate
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that by 2010 the Wet AMD market will be a multi-billion dollar
opportunity based on aging demographics, growing treatment rates,
use of combination therapies and price.
By communicating the importance of early diagnosis and timely
treatments to physicians, patients and caregivers, we can
maximize the benefit of Macugen to preserve vision in more
patients.
Our partner Pfizer, is a recognized leader in this type of market
expansion. Since 1998 for instance, the (steth) in market for
cholesterol has grown three times even though it is served by
multiple products with the same mechanism of action.
We strongly believe there is room for multiple anti-VEGF agents
in this large and growing AMD market much like the industry has
already experienced in multiple sclerosis and oncology.
Our first mover advantage with Macugen, our partnership with
Pfizer, our advantage in dosing schedule and our proven safety
make us especially confident of our continued success in the AMD
market.
We benefit from a strong and productive partnership with Pfizer.
This relationship is more than financial as Pfizer and Eyetech
collaborate to define and execute the strategy for clinical
development, marketing and sales of Macugen.
As early as this morning, Pfizer management has reaffirmed to us
that their plans for Macugen have not changed. This partnership
with Pfizer has resulted in robust clinical development and
commercialization plans for Macugen.
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Eyetech and Pfizer are expanding the Macugen franchise into two
other large markets of urgent unmet medical need where there are
presently no approved drugs.
In addition, presently there are no ongoing clinical trials with
any other anti-VEGF therapy besides Macugen for these large
markets. First is our program in diabetes. Let me remind you of a
few statistics. The incidence of diabetes in the US 18 million
and growing. We all know there's an epidemic of diabetes.
Diabetes is a leading cause of blindness in people under age 50.
Three quarters of diabetes develop retinopathy within ten years.
About 5.3 million people suffer from diabetic retinopathy.
Presently there are approximately 500,000 people suffering from
Diabetic Macular Edema or DME, where we've already shown proof of
principle in phase two and which is a leading cause of blindness
in diabetic retinopathy with approximately 75,000 new cases per
year in the US alone.
As announced, we plan to begin our pivotal phase II III trial of
Macugen and Diabetic Macular Edema in the second half of this
year with a secondary endpoint of progression of diabetic
retinopathy.
We expect to enroll and complete the first year of this study by
the end of 2008 when we will have the opportunity to file the
data with European regulatory authorities.
We expect to finish the third year of the trial by the end of
2010 when we will have the opportunity to file in the US. The
second major opportunity is retinal vein occlusion or RVO with an
estimated 130,000 new patients each year in the US alone.
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Depending on the results of our phase II trial currently
underway, we may start a phase III trial of Macugen in renal vein
occlusion as early as 2007 with a potential regulatory filing in
the US in the second half of 2009.
Again, Eyetech is conducting these research programs in
partnership with Pfizer who is responsible for the majority of
ongoing development costs.
We also have exciting news to share about Eyetech's other R&D
programs. Today we are announcing plans to move a preclinical
product into clinical development for macular degeneration. At
our R&D facility in Lexington, Mass and in collaboration with
Archemix, we have completed pre-clinical proof of concept for our
anti-PDG (aptimer). This exciting compound, the result of our
collaboration with Archemix has been shown to be synergistic with
Macugen laboratory studies. This has the potential to be a
powerful one, two punch in the treatment of eye disease because
we believe anti-PDGF strips away the parasites and allows
anti-VEGF therapy to work more effectively.
We anticipate moving into the clinic with a phase one study of
anti-PDGF and Macugen during the second half of 2006 pending
successful completion of required pre-IND studies.
Now this research is important because we believe that
combination therapy will emerge as the new standard of care of
macular degeneration, a market historically dominated by surgical
interventions and monotherapies is rapidly becoming a market
where combinations sequential in step therapies are the rule.
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Consider how the oncology market is now dominated by combination
therapies or consider how the cardiovascular market now relies on
pharmacology to prevent and manage heart disease.
There is a strong scientific rationale for combining therapies to
provide patients with enhanced efficacy and durable treatment
benefit. This trend is likely to increase the overall value of
the market and expand it.
In a small uncontrolled trial of Macugen in combination with
photodynamic therapy, 60% of patients gained three lines of
vision. This was the highest gain rate ever reported in this
disease. In addition, multiple preclinical studies have shown
that combination may be synergistic.
In March of this year, Pfizer and Eyetech enrolled the first
patient in our phase 3b/4 study of Macugen in combination with
photodynamic therapy. We expect to complete enrollment by the
second half of 2006.
Just as Eyetech revolutionized the treatment of neovascular AMD
with the first anti-VEGF agent, Eyetech plans on always being on
the cutting edge of new therapies for AMD. We believe that drug
delivery and novel combination therapy has the potential to be
the next major breakthrough.
Now by introducing Macugen early this year, Eyetech and Pfizer
are leading a revolution in the treatment of macular
degeneration. Macugen is the first and only FDA approved
treatment for all types of neovascular AMD. The retinal community
is presently adopting Macugen at a rapid rate.
For the first quarter, we reported rapid uptick of Macugen with
gross product revenue of 25.4 million.
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We have secured reimbursement eligibility by Medicare in all 50
states which we believe has contributed to rapid product
adoption.
As of the end of March, reordering has been strong. Among our top
100 accounts, 99 have already reordered Macugen. Nine out of ten
have ordered four or more times and about half have ordered seven
or more times.
Since we founded this company five years ago, we have met or
exceeded very milestone we have set. We are making a difference
today not promising one in the future. Just yesterday a patient
in Detroit handed a note to our Chief Operating Officer while he
was visiting an account. It said, I just received my 20th shot of
Macugen. And as my family keeps telling all who will listen, this
shot saved my way of life. Thank you so much for your study
programs and my wonderful eyesight.
Now let's move to recent news from a potential competitor to
Macugen. The street and the media reacted quickly to news
announced earlier this week by Genentech. The topline data
appeared to have further confirmed anti-VEGF therapy as the new
treatment paradigm for macular degeneration. However, the jury is
still out about this investigational product for AMD.
Here's our assessment of what we know and what questions remain
unanswered. This insight comes from discussions with rental
specialists, our partners at Pfizer and our management team which
includes 11 ophthalmologists with significant patient care and
clinical trial experience.
First, what do we know? The information presented so far is
clearly early and incomplete. This is topline data. From the
first year of a two year study in patients with minimally classic
and I'll call it lesions only. A second head to
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head pivotal trial against PDT that will be required for approval
has not yet reported any data.
A third trial in combination with PDT, Focus has not yet reported
any data. And a fourth trial with a different dosing schedule
peer is ongoing.
The trial included a curiously high success rate of 62% in the
controlled group of patients who received no treatment at all.
This response is inconsistent with the damaging progressive
natural history of Wet AMD. In fact, it is higher than the
success rate for the treatment group in the PDT cap trials that
gained approval for Visudyne and raises several critical
questions. Was this due to the clinical trial design or patient
characteristics?
Clearly almost 2/3 of patients responding to placebo at one year
is not the destructive macular degeneration disease most experts
are used to.
Did they study only an unusual more benign variant of the disease
such as (polyportal) or wrap lesions? We need to see
demographics. Or could it be due to the method for testing the
patient's visual acuity? Importantly, valid comparisons of
products cannot be made based on data from separate studies
especially in macular degeneration. We have learned this over and
over again.
Clinical trial results vary significantly based on patient
populations studied and protocols of clinical trials.
Since we're most familiar with our Macugen data, let me
demonstrate the importance of patient selection by sharing three
different data sets from the Macugen vision trials. As a
reminder, the vision trial studied all patient types and lesion
sizes. This diverse real-world patient population included
patients
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with more advanced stage disease with scarring similar to
advanced stages in cancer and led to full broad FDA label for
Macugen.
In this setting, the Macugen response rate was 70% compared to
the control group of 55%. Now when we looked at our patients with
early lesions, those more likely to respond because they have
less scaring, the Macugen response rate increases to 77% compared
with a control of 50%. This is 27% difference similar to
Genentech's reported number in their press release.
In fact, this data which was previously presented at ARVO
scientific meeting also showed that up to 20% of Macugen patients
compared to zero percent of controls gained three or more lines
of vision in this retrospective analysis.
The response rate increases even further for Macugen when you
look retrospectively at a small group of patients from one of our
trials. This group of patients had initially classic and occult
lesions, the same population of the Genentech trial with small
lesions and no previous thermal laser therapy.
In this group, the response rate for Macugen was 88% with a
control rate of 56% for a difference of 32% which is essentially
the same as the 33% noted in the Genentech trial. Again, this is
not a valid comparison of the two products. But it doesn't
demonstrate the importance of patient demographics when
interpreting clinical trials.
Results should improve by treating patients earlier before
scarring. We eagerly await more details on the design and patient
demographics of the Genentech trial. But remember, only a head to
head trial can accurately distinguish between products.
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Now there are significant regulatory hurdles for approval of any
new treatment for neovascular AMD. At the FDA advisory panel for
Macugen, the agency stated that two prospective randomized
clinical trials are required for two years for the approval of a
new treatment for AMD. Again, Macugen has cleared this hurdle
with proven efficacy and safety over two years.
We know that Genentech's investigational product requires greater
frequency of dosing once a month while Macugen is dosed every six
weeks. We see this as a major advantage. As the competitor
requires 50% more injections through two years of anti-VEGF
therapy. We know that Genentech is investing the viability of
less frequent dosing in the peer study. This approach is at odds
with data from our phase III trials and our preclinical studies
that show that continuous VEGF inhibition is best for patients
with neovascular AMD just like constantly keeping cholesterol
levels down is important for hypo cholesteremia.
Eyetech and Pfizer also have a drug delivery collaboration that
has already shown preclinical proof of principle for Macugen
microspheres that may result in even fewer injections.
Now researches in Genentech have suggested in public scientified
meetings that their product may not work in combination with
photodynamic therapy. Inflammation has also been reported. To our
knowledge, Genentech has not yet shared results from its FOCUS
Study at PDT in combination with their antibody fragment despite
the fact that this study was enrolled and completed prior to
MARINA.
As we mentioned -- this is important, since like in oncology and
heart disease, treatment of macular degeneration will most likely
involve combination therapies over the longer term. Macugen
administered with PDT is safe based
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on our present safety data and could be a major advantage for us
in the future. We look forward to seeing data from Genentech's
focus trial.
Now let's discuss what we and the medical community don't know.
What are the detailed results from the first year of MARINA? What
patient groups and lesion types achieved a 95% benefit in the
clinical trials? What was the dropout rate? What definitions are
used to describe response rate?
While the current press release highlights patients who maintain
or gain vision, this group includes patients who lost up to three
lines of vision. This is clearly not maintaining vision. This
statement is misleading and inconsistent with our common
understanding how ophthalmologists measure vision loss and gain.
What are the results from the second year of MARINA? What are the
results of the second middle phase three trial anchor and what
are the results of the combination focus study? What are the
possible safety concerns in administering a VEGF inhibitor that
blocks all isoforms when VEGF plays such an important role in
maintaining and developing blood vessels and neurons?
The Genentech product blocks all VEGF indiscriminately while
Macugen selectively blocks only the bad or pathological isoform
VEGF 165. Lucentis is a fragment of Avastin which has a black box
warning with thromboembolic and hemorrhagic effects.
The long term safety of the product must be well studied to be
sure there is no such toxicity in the eye. In addition, Genentech
reported at this year's ARVO scientific meeting that 14% of
patients had newly developed systemic hypertension during their
early trials. We did not see this in the Macugen
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phase III trials. Could this be a systemic safety issue for the
Genentech product? Only long term studies will answer this
important question.
In summary, our current understanding of Genentech's interim data
actually raises more questions than it answers. We encourage you
to keep these questions in mind as we learn more about the
competitive environment.
There is a human tendency to want to compare and contrast things
that seem similar. But it is not appropriate yet to draw
comparisons between the Macugen and Genentech trials. This would
be like comparing apples to oranges. Only a head to head, apples
to apples can accurately distinguish products.
We strongly believe there is room for multiple anti-VEGF agents
in this large and growing AMD market much like the industry has
experienced in the multiple sclerosis and oncology areas.
Our first mover advantage with Macugen, our partnership with
Pfizer, our advantage in dosing schedule and our proven safety
through two years make us especially confident of our continued
success in the AMD market.
In closing, I want to share a statement from an editorial in
yesterday's New York Times about this new Genentech data. There
are good reasons to wait before cheering too loudly. Too few
details have been released to judge how many patients got better
and how great their improvement was.
The MARINA Study has yet to be presented at a scientific
conference or published in a peer review journal. And the results
stem from only the first year of a two year trial. There are
thousands of anxious patients who will need
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to await further analysis of the MARINA data to determine whether
these findings add up to progress or not.
Now as Chris mentioned, we are joined today by two senior rental
specialists, Dr. Don DAmico, Professor at the Massachusetts's Eye
and Ear Institute at Harvard Medical School and Dr. Carmen
Puliafito, Professor and Chair of Ophthalmology at the Bascom
Palmer Eye Institute at the University of Miami. Dr. DAmico,
would you like to comment on Macugen and your thoughts on the
press release?
Donald J. DAmico: Yes. Well thank you David. As a physician, I certainly
welcome any new therapy that will demonstrate efficacy against
his very difficult disease of Web AMD. However I feel that our
decisions and our analyses must be based on critical evaluation
and objective evaluation. And it's quite clear for the many
reasons that you've outlined that this is not a comparative trial
at all and that the fragmentary data that we have so far seen
raises many questions and we cannot make definite comments about
any kind of comparative efficacy.
We do have a strong indication that the anti-VEGF approach is
further validated by the fact that the primary endpoint is
achieved at the one year interval. However, we do not have any
longer term data. We do not have information about other forms of
the disease.
And I really would like to emphasize the aspect of not trying to
compare numbers from one trial to another. It is precisely this
pitfall that is such that historical controls are never permitted
in analysis of critical data. And we can speak further about
this. But any attempt to look just a numbers from one trial to
another really misses the science. And it's the science that will
guide us into intelligent selection of treatments for our
patients.
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David Guyer: Thank you. Dr. Puliafito, would you like to comment?
Carmen A. Puliafito: Yes. Thank you very much David. Well, Macugen remains our
primary therapy for all forms of (corodial) vascularization and
AIDS related AMD. We've changed our treatment algorithm since the
launch of Macugen. And it remains our primary treatment option.
I look at the Lucentis results as validating in fact, the Eyetech
pioneering approach to the treatment of macular degeneration
because one of the issues has been is how central is the role of
anti-VEGF therapy in the treatment of (corodial)
neovascularization? And I think the evidence now is overwhelming
that Macugen and other agents that are anti-VEGF will need to be
included in the treatment of all patients with the acute form of
(corodial) neovascularization. And I think that's a major
recognition.
I'd like to say that macular degeneration is a devastating
disease. And what we've seen even since the launch of Macugen,
that the market as Dr. Guyer suggested, was underserved and much
larger than we realize.
And I happen to believe that the market will increase in a very
substantial way, that going forward probably, we will use a
variety of agents for treating this very vexing problem. Many
ophthalmologists are enthusiastic about combination therapy using
Macugen in combination with other agents. And I'm also very
enthusiastic about the Eyetech pipeline.
We all know that repeated (intervitiual) injections is probably
not the best strategy in the future. So we really need to look at
delivery options. We really need to look at other approaches such
as Eyetech has proposed to not only just stop the vessels from
leaking, but to get the vessels to wither away. So these are very
important. And I have a lot of confidence in the scientific team
at
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Eyetech led by Tony Adamis. And I think that this is going to
lead to many contributions to ophthalmology going forward.
So in summary I would say Macugen showed us that anti-VEGF
therapy is the keystone of treatment for macular degeneration.
It's still our primary modality. And we're enthusiastic about
future developments. Thank you.
David Guyer: Thank you. We will now open the call to questions for Eyetech
senior management or either of our guest physicians.
[Q&A Session]
Chris Smith: Good. Thank you everyone. That concludes our call for today. We
remind you that the views and positions of Dr. DAmico and Dr.
Puliafito are their own and are not necessarily the views and
positions of Eyetech. Thank you very much for joining us and have
a good day.
Operator: Thank you. This does conclude today's conference. You may now
disconnect.
END
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