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8-K - FORM 8-K - OSI PHARMACEUTICALS INC | y84029e8vk.htm |
EX-99.1 - EX-99.1 - OSI PHARMACEUTICALS INC | y84029exv99w1.htm |
EX-99.3 - EX-99.3 - OSI PHARMACEUTICALS INC | y84029exv99w3.htm |
Exhibit 99.2
On April 22, 2010, OSI Pharmaceuticals, Inc. (the Company) is holding a webcast conference
call regarding its financial results for the quarter ended March 31, 2010 as well as an update on
the Companys business. A copy of the script to be used in connection with the call, including
remarks by Kathy Galante, Investor Relations, Colin Goddard, Ph.D., Chief Executive Officer of the
Company, Pierre Legault, Chief Financial Officer and Treasurer of the Company, and Gabe Leung,
Executive Vice President of our Pharmaceutical Business, follows below.
Kathy Galante:
Good Afternoon and welcome to our first quarter earnings call. Joining me today, I have Colin Goddard, our Chief Executive Officer, Pierre Legault, our Chief Financial Officer, Gabe Leung, head of our oncology/diabetes business activities and Jon Rachman, head of our UK diabetes/obesity R&D.
Good Afternoon and welcome to our first quarter earnings call. Joining me today, I have Colin Goddard, our Chief Executive Officer, Pierre Legault, our Chief Financial Officer, Gabe Leung, head of our oncology/diabetes business activities and Jon Rachman, head of our UK diabetes/obesity R&D.
Before we begin, I would like to remind you that we will be making forward-looking statements
relating to financial results and clinical and regulatory developments on the call today. These
statements cover many events that are outside of OSIs control and are subject to various risks
that could cause the results to differ materially from those expressed in any forward-looking
statements. I refer you to our SEC filings for a detailed description of the risk factors
affecting our business.
I would also like to inform you that todays presentation will include certain non-GAAP measures
for both our 1Q 2010 results and 2010 guidance. Management uses these non-GAAP measures internally
to evaluate the performance of the business, including the allocation of resources as well as the
planning and forecasting of future periods. We believe that these non-GAAP results are useful to
analyze our core operating performance. The non-GAAP measures adjust for non-cash tax expense to
reflect our actual cash tax rate of approximately 3%, for expense related to equity-based
compensation, for non-cash interest expense related to the adoption of FSP APB 14-1 now known as
ASC 470, and for certain other items. A complete reconciliation of Adjusted-GAAP to GAAP for our
Q1 2010 results is included in our earnings release, and we have also prepared a reconciliation of
our adjusted GAAP to GAAP 2010 guidance. Both the earnings release and the reconciliation of our
2010 adjusted GAAP guidance are available on our website, www.osip.com
Id now like to turn the call over to Colin for some preliminary comments.
Colin Goddard
Thanks Kathy, and thanks to everybody for joining us for todays call.
Thanks Kathy, and thanks to everybody for joining us for todays call.
Clearly the first quarter of 2010 has been impacted both financially and strategically by events
surrounding the $52 per share unsolicited tender offer initiated by Astellas Pharma, Inc. on March
1st. On March 15th the Company made its 14D-9 filing in response to the
Astellas offer. The OSIP board, after carefully considering all aspects of the proposal,
determined that the Astellas offer was inadequate and substantially undervalued the Company and
recommended that stockholders reject the Astellas offer. The filing noted
that the Company has non-strategic financial assets valued in excess of $1.3 billion and that- as
such Astellas was apparently subscribing only approximately $2.3 billion to the Companys
strategic assets including Tarceva and our oncology and diabetes/obesity franchises.
In addition, as we reported last week Tarceva received U.S. regulatory approval for NSCLC patients
in the first-line maintenance setting. Given the Companys unprecedented and widely unexpected
success in obtaining the full, broad maintenance label for this indication in marked contrast to
a 12-1 ODAC recommendation against approval on December 16th of 2009, we believe this
value is unlikely to have been appropriately represented in peoples models. This was a
tremendous achievement for our regulatory and clinical team which was responsible for spearheading
the SATURN registration effort here in the U.S. and which devised the post-ODAC strategy. I am
personally not aware of another situation where a near unanimous recommendation against approval by
an advisory committee has not been adopted by FDA. We believe the outcome speaks volumes for the
quality of our oncology team here at OSI and the willingness of the FDA to objectively review the
facts and data surrounding the situation. The US approval came on the heels of a CHMP positive
opinion for approval in the first line maintenance setting for patients with stable disease which
we announced on 19th March.
In our 14D-9 filing, we also reported that the board had instructed the management team together
with the assistance of an outstanding team of advisers comprising Centerview Partners and Lazard on
the investment banking side and Skadden Arps on the legal side to explore the availability of a
transaction that reflects the full intrinsic value of OSI. While there cannot be any assurance
that a transaction will take place, the board also allowed that third parties would be afforded
access to a due diligence exercise upon signing of an appropriate non-disclosure agreement. On
29th March, we announced that we had signed a confidentiality agreement which allowed
Astellas to enter our ongoing process under terms that were substantially similar to those offered
to other parties in the process and which included a short standstill period through May
15th, 2010. We took this step which reflects our boards prior commitment to explore
the availability of a transaction that reflects the full intrinsic value of our Company in order
to ensure that our stockholders have the full benefit of a complete, open and fair process.
Today, the process is ongoing with several parties (in addition to Astellas) conducting diligence.
However, in keeping with the goal of conducting our process as effectively as possible, we will not
be commenting further on Astellas offer or the ongoing process on todays call and neither will we
be able to respond to questions on the same topics.
None-the-less, and notwithstanding the obvious distractions of the ongoing process, we are pleased
to report on another solid quarter of progress for the Company. Shortly Pierre will provide you
with a summary of the financial results and a short update on our ongoing Ardsley consolidation of
U.S. operations after which Gabe will provide some commentary on Tarceva. I will then return to
provide a view on intrinsic value and a few pipeline highlights prior to hosting a question and
answer period.
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Now over to Pierre.
Pierre Legault:
Thank you Colin
Good afternoon.
Thank you Colin
Good afternoon.
Today we reported adjusted income from continuing operations of $40 million for the first quarter
2010, an increase of 10% when compared to $36 million for Q1 last year. Fully diluted adjusted GAAP
EPS from continuing operations was $0.63 per share for Q1 and our GAAP EPS was $0.08 per share.
The lower GAAP EPS was primarily due to $11 million of accrued and direct expenses related to the
Astellas tender offer, Ardsley site consolidation costs of $4 million, and the Aveo market value
impairment adjustment of $8 million following that companys IPO.
Turning to revenues overall, total OSI revenues for the first quarter were $107 million, an
increase of 14% over the prior year.
Our Tarceva-related revenue, which includes our profit split in the US, selling, marketing, and
manufacturing reimbursements, royalties, and milestone amortization, increased 10% to $92 million
for the quarter, compared to $84 million a year ago.
As reported by our collaborator Roche, Tarceva worldwide net sales for the first quarter were $308
million, an increase of 10% compared to last year.
Worldwide first quarter net sales were comprised of US net sales of $114 million and rest-of-world
net sales of $194 million.
First quarter 2010 Tarceva US revenues to OSI were $52 million, an increase of 6% from 1Q2009.
Tarceva U.S. net sales of $114 million grew 2% compared to 1Q 2009. As expected from historical
precedent, U.S. Tarceva sales for the first quarter of 2010 were negatively impacted by lower
prescription fill rates due to higher patient rejection rates related to the reset of the
donut-hole for Medicare Part D patients. In addition, Genentech recorded a small reserve
adjustment in 1Q2010 to account for the Medicaid rebate provision of the recently enacted
healthcare reform legislation which was effective retroactively to January 2010.
Separately, and in addition to the donut hole reset, fluctuations in days on hand inventory
levels and effective selling days contributed to the sequential quarter decline in sales from
4Q2009.
First quarter 2010 rest-of-world Tarceva royalty revenues at $40 million increased 17% when
compared to 1Q2009. Tarceva rest-of-world net sales remained consistent compared to the fourth
quarter of 2009. Rest-of-world net sales of Tarceva in Q1 2010 were positively impacted by
increased demand equating to approximately $14 million and were also favorably impacted by a
weakening U.S. dollar when compared to the first quarter of 2009.
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However, on a sequential basis, 1Q 2010 rest-of-world Tarceva net sales were positively impacted by
increased demand of $8 million and negatively impacted by unfavorable foreign exchange rate
fluctuations of $10 million.
DPIV related royalty revenues increased 42% to $13 million for the quarter, compared with $9
million a year ago. Note that royalties are lower than Q4 2009 on a sequential basis which reflects
the tiered structure of our royalty agreement with Merck and will build back up as sales increase
through the year. For your future planning we estimate that an average annual royalty of
approximately 2.5% should be applied for the DP-IV estate.
Shifting to expenses, the total operating expenses from continuing operations for the quarter were
$88 million. However, there were a number of new expense items incurred in 1Q2010 that were not
present in the prior year quarter. These include Ardsley site consolidation costs of $4 million,
other operating expenses relating to the Ardsley site project of $2 million and $11 million of
expenses related to the Astellas tender offer. Excluding these items, operating expenses were $71
million compared to $62 million during the first quarter of 2009. Appropriately $6 million of the
increase is coming from higher development costs associated with key strategic programs as they
continue to progress into later phases of development.
R&D expenses increased by $7 million to $42 million. The breakdown of the R&D expenses for the
quarter was approximately 79% related to oncology projects and 21% for diabetes and obesity
projects. Tarceva-related spending at $10 million was approximately 29% of the oncology R&D
expenditures and 23% of total R&D spend.
SG&A expenses were $29 million in Q1 2010 which is consistent with Q4 2009, and higher than Q1
2009.
You will recall that we previously announced a program to consolidate our U.S. operations onto a
single campus at our site in Ardsley, New York. Construction and renovation work is going well and
we initiated the first wave of relocation of our U.S operations from various sites in the U.S. to
Ardsley, which will become our oncology hub and headquarters for OSI. We will intensify relocation
next month in May and expect the move to be completed by the end of 2010, with a majority of the
people relocating during the summer.
I would also like to point out that other income (expense) includes a recorded impairment charge of
$7.9 million, which reflects a reduction in the carrying value of our investment in AVEO
Pharmaceuticals, Inc. from $20.5 million to a fair market value of $12.6 million which is the
result of its initial public offering in March 2010.
Turning to the balance sheet, we finished the quarter with $533 million of cash and investments.
Our investments continue to be conservatively managed with a large portion invested in triple A
rated securities. Yesterday we completed a process to convert our 2023 notes, with a book value of
$60.4 million, into approximately 1.2 million shares.
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Please note that these shares were already part of our diluted share base in our adjusted EPS
calculations, and the successful conversion will result in interest charge cash savings of
approximately $2.0 million per year on a going forward basis.
2010 Guidance
Given uncertainties around costs and timings associated with our ongoing process we have decided to
limit the guidance we will provide to that of updated total corporate revenue guidance for the full
year 2010 and a reaffirmation of our prior greater than 10% adjusted EPS guidance.
Total revenue is expected to increase by approximately 17% and reach $500 million during 2010. This
includes revenues from unconsolidated joint business with Genentech on US sales, royalties from
Roche on rest-of-world sales, the amortization of Tarceva-related milestones, and the royalties and
milestones from our DPIV patent estate.
Thank you and now over to Gabe.
Gabe Leung:
Thanks, Pierre.
Thanks, Pierre.
As Pierre has noted, 1Q sales totaled $308 million worldwide, representing the second highest
quarterly sales ever reported, with 4Q09 being the highest. The lower 1Q sales as compared to 4Q09
were expected and were driven primarily by a decline in the US, where we saw the usual 1Q drop in
fill rate as driven by reimbursement factors such as the Medicare donut hole reset. Market share
indicators appeared to be stable. As in the past years, we expect the fill rate to improve as we
move into future quarters.
Perhaps most importantly, we are very pleased with the ultimate approval by the FDA of Tarceva for
the maintenance treatment of NSCLC patients after first line chemotherapy for all patient types.
This approval was based on the SATURN study, which was a large, multi-centered, well controlled
randomized Phase III study which met its primary PFS endpoints and met the key overall survival
secondary endpoint. Tarceva is now the only drug approved for use in this setting across all
patient subtypes, regardless of biomarker status and histology which includes both non-squamous and
squamous cell types. We expect this new indication will help re-ignite volume growth in the US.
As previously discussed with investors we at OSI see this indication as a potential $500
million/year opportunity in the U.S. an opportunity model that fully accounts for the
anticipated strength of Alimta in the non-squamous cell population in this setting. Recall that
neither Alimta nor Avastin are approved for maintenance use in the squamous cell population. A
launch meeting with the Genentech/OSI sales forces for this new indication is scheduled in a few
weeks. In Europe, we expect an imminent approval based on a positive recommendation by the CHMP to
approve Tarceva for use in the maintenance setting for patients who have stable disease after first
line chemotherapy. The anticipated approval in Europe is also expected to be across all patient
subtypes, and regardless of histology and biomarker status, for patients with stable disease making
Tarceva the only maintenance treatment option for patients with squamous histology worldwide. The
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focus on stable disease patients is clinically reasonable, and competitively desirable, as patients
who did not get a response (CR or PR) from initial chemotherapy are more likely to benefit from a
switch-over to a non-cytotoxic agent like Tarceva. This is the patient subset for which we believe
we will be very competitive even in the context of the JMEN results for Alimta and anticipate that
this may provide for upside in the US setting also.
The life cycle management program for Tarceva remains strong and on track. The accrual to EURTAC,
a study comparing Tarceva to standard platinum based chemotherapy for front line treatment of NSCLC
patients known to have an activating EGFR mutation, is on schedule, with potential interim data in
the latter part of this year or final analysis in 2011. We plan to sign a contract with a partner
for companion diagnostic development this quarter. We expect the adjuvant study in NSCLC, RADIANT,
to finish accrual this quarter as well, and in turn provide final data in 2013 / 2014, or
potentially interim data in 2012. We also expect data from the CALGB never smoker study to be
available at ASCO this year. Given the potential number of patients with an activating EGFR
mutation in this study, we very much look forward to seeing whether the addition of chemotherapy to
Tarceva offers any clinical value on top of Tarceva monotherapy alone and the study will, we
believe, serve to further accentuate the value of using Tarceva in regimens targeting NSCLC
patients whose tumors harbor an activating mutation. The continued expansion of awareness of data
like these demonstrating the potential importance of Tarceva in the treatment of EGFR mutation
patients, the publication of key clinical datasets for EGFR mutation patients including those
for patients in the EGFR mutation sub-set in the SATURN trial and the recently updated NCCN
guidelines should all help to continue to increase the awareness of patients and their physicians
of this information as they make their treatment choices.
Outside of lung cancer, data from the ovarian maintenance trial and the HCC study, SEARCH, are
expected in 2011 and 2012, respectively. A recent interim safety analysis of the SEARCH study was
satisfactory and the study continues to enroll.
With that, Ill turn it over to Colin.
Colin Goddard:
Thanks Gabe.
The irony of the Astellas offer is that it has enabled us to focus attention away from some of the
near-term topics such as U.S. sales trends and the SATURN/ODAC saga that tended to dominate recent
investor interactions prior to the offer and onto the robust, fundamental intrinsic value we have
built into the Company over the last 5-10 years. The lack of growth in U.S. sales over the last
several years can be attributed at least in part to the fact that there have been no new
indications for Tarceva in the U.S. since 2005. Clearly we believe that the recent maintenance
approval will provide a reacceleration of U.S. sales growth, but even more importantly the
SATURN approval kicks-off a period of time where (as Gabe mentioned) we have the potential to see
successive new indications for the brand including: combination approvals with other molecular
targeted therapies (for example the Sutent/Tarceva phase III in NSCLC); the RADIANT/adjuvant
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study in the stage I through IIIa NSCLC population; the HCC and ovarian trials; and, notably, the
EGFR mutation opportunity. In fact, if we just consider the existing indications for the brand and
add on the potential expansion into the EGFR mutation population, which most commentators while
they may debate timelines agree is likely, we should see significant growth. We, at OSI, model
this scenario as generating north of $7 billion in cumulative revenues to OSIP from the Tarceva
franchise alone through the 2019/20 periods of patent exclusivity in the major U.S., E.U., and
Japanese markets.
Beyond Tarceva, and having borrowed a page out of our partner Genentechs playbook, we have
invested consistently over the last decade or so in our underlying scientific platforms, cancer
cell biology, EMT platform and translational research. As a result and, having adopted a
programmatic approach to our development pipeline, we are starting to see some meaningful
differentiation emerge in our clinical assets, most notably OSI-906 and PSN821.
Our IGF-1r/IR co-inhibitor OSI-906 program is the beneficiary of significant EMT and related
compensatory signaling biology research which led us to predict that agents targeting IGF-1R alone
might struggle to demonstrate meaningful activity in the clinic due to a compensatory signaling
adoption of the Insulin receptor signaling pathway in many tumors. Furthermore, additional
signaling cross-talk with the EGFR pathway and an EMT tie-in suggests a unique benefit for
Tarceva/OSI-906 combinations. As such, we believe that the challenges recently observed in the
clinic with IGF-1R antibody agents only serve to accentuate the differentiation offered by OSI-906.
In addition we have now reached the target combination doses of Tarceva and OSI-906 in our ongoing
phase Ib combination study and are on-track to start a critical Phase III trial combining OSI-906
with Tarceva in first line NSCLC patients whose tumors harbor an activating EGFR mutation in the
second half of this year.
Our leading clinical candidate on the diabetes and obesity side is our GPR119 agonist PSN 821 which
is currently undergoing a 14 day treatment period clinical trial. The OSI GPR119 program is the
only one to consistently talk-about and present data suggesting that, concomitant with glycaemic
control, fully optimized GPR119 drug candidates should also elicit weight loss. Such an activity
spectrum in a well tolerated, oral therapy for type II diabetes would clearly be an exciting next
generation GLP-1 modulating product. We previously presented data to investors at our analyst day
demonstrating the ability of PSN821 to lower blood glucose. We have now obtained preliminary data
from the ongoing trial which is an in-clinic study showing positive data in widely used and
standardized surrogates of weight loss, a potentially break-out development for our program.
Although a more complete elucidation of the considerable value that we believe to be inherent in
these two high quality, differentiated and potentially blockbuster development programs is
built into the 2012 timelines previously presented to investors, these important developments serve
as valuable intermediary benchmarks of the Companys continued progress toward building exceptional
long-term value.
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Together with our progress on Tarceva we believe these elements combined with the fundamental
financial strength of the Company anchored around over $1.3 billion in non-strategic financial
assets provide us with considerable confidence as we continue the ongoing process to explore the
availability of a transaction recognizing the full intrinsic value of the Company, even as we also
continue to execute on our core business and strategic plans.
We thank you for your continued support and will now be happy to take your questions. As a
reminder, however, we will not be taking questions on the Astellas offer or the ongoing process.
Additional Information
This communication does not constitute an offer to sell or the solicitation of an offer to buy any
securities of any stockholder of OSI Pharmaceuticals, Inc. (OSI).
In connection with the unsolicited tender offer commenced by Astellas, OSI has filed a
Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC (as amended, the Schedule
14D-9). STOCKHOLDERS OF OSI ARE URGED TO READ THE SCHEDULE 14D-9 AND OTHER DOCUMENTS FILED WITH
THE SEC CAREFULLY IN THEIR ENTIRETY BECAUSE THEY CONTAIN IMPORTANT INFORMATION. Stockholders may
obtain a free copy of the Schedule 14D-9 and other documents filed by OSI with the SEC through the
website maintained by the SEC at http://www.sec.gov. Stockholders may also obtain, without charge,
a copy of the Schedule 14D-9 from MacKenzie Partners, Inc., OSIs information agent, by calling
800-322-2885 toll free or by calling 212-929-5500 or by emailing osipharma@mackenziepartners.com.
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