425
Filed by Celgene Corporation
Pursuant to Rule 425 of the Securities Act of 1933
and deemed filed pursuant to Rule 14a-12
of the Securities Exchange of 1934
Subject Company: Abraxis BioScience, Inc.
Commission File No.: 001-33657
The following transcript relates to an analyst conference call held on June 30, 2010 in connection with the
announcement by Celgene Corporation (Celgene) of its proposed acquisition of Abraxis BioScience, Inc. (Abraxis
BioScience).
Forward-Looking Statements
This material contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties
and other factors not under Celgenes control. The Celgenes actual results, performance, or achievements could be
materially different from those projected by these forward-looking statements. The factors that could cause actual
results, performance, or achievements to differ from the forward-looking statements include the risk that the
acquisition of Abraxis BioScience may not be consummated for reasons including that the conditions precedent to the
completion of the acquisition may not be satisfied; the possibility that the expected benefits from the proposed merger
will not be realized, or will not be realized within the anticipated time period; the risk that Celgenes and Abraxis
BioSciences businesses will not be integrated successfully; the possibility of disruption from the merger making it
more difficult to maintain business and operational relationships; any actions taken by either of the companies,
including but not limited to, restructuring or strategic initiatives (including capital investments or asset
acquisitions or dispositions); and other risks that are discussed in Celgenes filings with the Securities and Exchange
Commission (SEC), such as Celgenes Form 10-K, 10-Q and 8-K reports and in Abraxis BioSciences filings with the SEC,
such as its Form 10-K, 10-Q and 8-K reports. Given these risks and uncertainties, you are cautioned not to place undue
reliance on the forward-looking statements.
Participants in Solicitations
Celgene, Abraxis Bioscience and their respective directors, executive officers and other members of their management
and employees may be deemed to be participants in the solicitation of proxies from stockholders of Abraxis Bioscience
in connection with the merger. Information regarding Celgenes directors and officers is available in Celgenes proxy
statement on Schedule 14A for its 2010 annual meeting of stockholders and Celgenes 2009 Annual Report on Form 10-K,
which were filed with the SEC on April 30, 2010 and February 18, 2010, respectively. Information regarding Abraxis
Biosciences directors and executive officers is available in Abraxis Biosciences proxy statement on Schedule 14A for
its 2009 annual meeting of stockholders and Abraxis 2009 Annual Report on Form 10-K, which were filed with the SEC on
October 30, 2009 and March 12, 2010, respectively. Additional information regarding the interests of such potential
participants will be included in the proxy statement and the other relevant documents filed with the SEC when they
become available.
Additional Information about the Transaction and Where to Find It
This material shall not constitute an offer of any securities for sale. The acquisition will be submitted to Abraxis
Biosciences stockholders for their consideration. In connection with the acquisition, Celgene and Abraxis Bioscience
intend to file relevant materials with the SEC, including a registration statement, a proxy statement/prospectus and
other relevant documents concerning the merger. Investors and stockholders of Celgene and Abraxis Bioscience are urged
to read the registration statement, the proxy statement/prospectus and other relevant documents filed with the SEC when
they become available, as well as any amendments or supplements to the documents because they will contain important
information about Celgene, Abraxis Bioscience and the merger.
Stockholders of Celgene and Abraxis Bioscience can obtain more information about the proposed transaction by reviewing
the Form 8-K to be filed by Celgene and Abraxis Bioscience in connection with the announcement of the entry into the
merger agreement, and any other relevant documents filed with the SEC when they become available. The registration
statement, the proxy statement/prospectus and any other relevant materials (when they become available), and any other
documents filed by Celgene and Abraxis Bioscience with the SEC, may be obtained free of charge at the SECs web site at
www.sec.gov. In addition, investors and stockholders may obtain free copies of the documents filed with the SEC by
directing a written request to: Celgene Corporation, 86 Morris Avenue, Summit, New Jersey, 07901, Attention: Investor
Relations, or Abraxis Bioscience Inc., 11755 Wilshire Blvd., Los Angeles, CA, 90025, Attention: Investor Relations.
Investors and stockholders are urged to read the registration statement, the proxy statement/prospectus and the other
relevant materials when they become available before making any voting or investment decision with respect to the
merger.
FINAL TRANSCRIPT
Jun. 30. 2010 / 1:00PM, CELG Celgene Corp. Conference Call to Discuss Strategic Acquisition of Abraxis BioScience
CORPORATE PARTICIPANTS
Bob Hugin
Celgene Corporation President and COO
Dave Gryska
Celgene Corporation SVP and CFO
Sol Barer
Celgene Corporation Chairman and CEO
Patrick Soon-Shiong
Abraxis BioScience, Inc. Executive Chairman
CONFERENCE CALL PARTICIPANTS
Brian Abrahams
Oppenheimer & Co. Analyst
Yaron Werber
Citigroup Analyst
Geoff Meacham
JPMorgan Analyst
Chris Raymond
Robert W. Baird Analyst
Geoffrey Porges
Sanford Bernstein Analyst
Mark Schoenbaum
ISI Group Analyst
Jim Birchenough
Barclays Capital Analyst
Jason Kantor
RBC Capital Markets Analyst
Mike King
Wedbush Analyst
Gene Mack
Soleil Securities Analyst
Ian Somaiya
Piper Jaffray Analyst
PRESENTATION
Operator
Welcome to the Celgene conference call and webcast to discuss the Companys announcement that it
intends to acquire the Abraxis BioScience. Your host for the call is Celgenes Chief Executive
Officer, Bob Hugin. Mr. Hugin, you may begin.
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FINAL TRANSCRIPT
Jun. 30. 2010 / 1:00PM, CELG Celgene Corp. Conference Call to Discuss Strategic Acquisition of Abraxis BioScience
Bob Hugin Celgene Corporation President and COO
Thank you very much, operator, and thank, everyone, for joining us this morning on short notice. We
appreciate it and we also want to thank everyone who has made this conference call possible,
especially since the deal terms were only finalized barely four hours ago.
With me in Summit, New Jersey this morning is Dave Gryska, Celgenes Chief Financial Officer, and
Sol Barer, Celgenes Executive Chairman. And in Los Angeles on the call we also have the Executive
Chairman of Abraxis BioScience, Dr. Patrick Soon-Shiong.
This morning we have a straightforward agenda and we have two things that we want to cover with
you. Sol will lead off with a strategic overview of the transaction. I will come back and give you
an update on the transaction, some of the important value drivers that have led to this transaction
and our plans for the future to benefit from this transaction.
The transaction clearly is a significant step forward as we establish Celgene as a major solid
tumor oncology company. Following my comments, Dr. Soon-Shiong will give the Abraxis BioScience
perspective on the pipeline and some other important aspects of Abraxis. Well come back and open
up the conference call to questions and answers to ensure that we cover all the elements that are
important to you. So thanks again for joining this morning and let me turn the call over to Dave
Gryska, our CFO, just to make sure we do everything properly here this morning.
Dave Gryska Celgene Corporation SVP and CFO
Thanks, Bob. Before we begin, we want to remind you that certain statements made during this
conference call may be forward-looking or made pursuant to the Safe Harbor Provisions of the
Securities Litigation Reform Act of 1995. Certain forward-looking statements which involve known
and unknown risks, delays, uncertainties, and other factors not under our control may cause actual
results, performance, or achievements to be materially different from the results, performance, or
other expectations stated or implied by these forward-looking statements. Statements in this
conference call relating to the consummation of the contemplated acquisition are subject to the
possibility that one or more of the closing conditions to the merger might not be satisfied,
including the possibility that regulatory approvals might not be obtained.
In addition, we are moving into a quiet period in connection with the transaction, so we are
limited on the details we can share. Statements related to the expected benefits of the
contemplated acquisition are subject to the risks that expected synergies will not be achieved and
that the operations, products, and employees of Celgene or Abraxis will not be integrated
successfully; that the market for Abraxis products may not develop as anticipated; and that Abraxis
products may not be approved by regulatory authorities as well as the general risks associated with
the respective businesses of Celgene and Abraxis as described in the periodic reports and other
documents filed by each of us with the Securities and Exchange Commission.
This announcement is neither an offer to purchase nor a solicitation of an offer to sell Celgene
shares. The merger is subject to approval of a majority of the outstanding shares of Abraxis common
stock and Abraxis will file with the SEC a proxy statement relating to the stockholders meeting at
a vote with respect the merger will be taken. Celgene will file a registration statement covering
the shares of Celgene common stock to be received by stockholders of Abraxis in the merger. An
offer of Celgene common stock will be made by means of a prospectus, which is part of the
registration statement. The proxy statement and prospectus will contain important information.
Stockholders are urged to read this information carefully before making any decisions about the
proposed merger.
Now Ill turn the call over to Sol with his comments on the acquisition.
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FINAL TRANSCRIPT
Jun. 30. 2010 / 1:00PM, CELG Celgene Corp. Conference Call to Discuss Strategic Acquisition of Abraxis BioScience
Sol Barer Celgene Corporation Chairman and CEO
Thanks, Dave. Today we are announcing an important milestone in our evolution towards becoming the
preeminent company in delivering innovative therapies to patients with serious debilitating and
fatal diseases. Specifically we are taking the next step in our expansion from a global leader in
therapies, the hematological malignancies to a company with an innovative solid tumor therapy
franchise by announcing our intent to acquire Abraxis BioSciences.
We are in the fortunate position of being able to leverage our global capabilities in hematology
oncology to grow the innovative Abraxis portfolio starting with ABRAXANE, a product approved in
metastatic breast cancer and which had exciting data in non-small cell lung cancer and pancreatic
cancer at the recent ASCO and the pipeline of solid tumor compounds. I would like to salute Patrick
Soon-Shiong and his team for the development of their innovative science in their exciting products
which will have an important impact on patients around the world.
As Bob will detail, this acquisition has strong strategic, commercial, scientific, clinical, and
financial rationales. We are very excited about this important step in Celgenes history and
bringing the Abraxis products and pipelines to the next level.
I will now turn the call over to Bob, who will provide an overview of the Company and delineate the
acquisition.
Bob Hugin Celgene Corporation President and COO
Thanks very much, Sol. As I hope you have seen this morning in the press release that was put out
early this morning that Celgene, we have agreed to acquire all the outstanding shares of Abraxis
BioScience at a value of $72 per share in a combination of cash and common stock and that mix being
a little over $2.4 billion in cash and a little under $600 million in Celgene stock. Abraxis
BioScience shareholders will also receive Contingent Value Rights for future milestones that create
meaningful additional value for Celgene and Abraxis shareholders. These Contingent Value Rights
will be registered with the Securities and Exchange Commission and we anticipate following
regulatory reviews that this transaction will close in the fourth quarter of this year.
Many investors may not be that familiar with Abraxis BioScience. Abraxis is a global integrated
biotechnology company founded by Dr. Patrick Soon-Shiong headquartered in Los Angeles, California.
The company has approximately 900 employees based in locations in the United States, Australia,
Canada, China, and the United Kingdom. ABRAXANE is the lead product and was approved for metastatic
breast cancer in 2005 by the FDA and approved in Europe in 2008. ABRAXANE generated $315 million in
sales in 2009 and $88 million in the first quarter of 2010.
There are additional important future growth drivers in addition to breast cancer. As Sol
mentioned, data was recently presented at ASCO demonstrating that ABRAXANE met its SPA-approved
response rate end point in a Phase III first-line non-small cell lung cancer trial. This data is
expected to be submitted to the FDA in the first half of 2011 for regulatory approval.
Data was also presented earlier this year from a Phase I/II study in pancreatic cancer that showed
a doubling of overall survival versus historical controls. These impressive results have led to the
initiation of a global Phase III study in pancreatic cancer which is rapidly enrolling.
Abraxis has developed the nano particle albumin-bound technology platform beyond ABRAXANE and has a
robust development pipeline that has the potential to improve patient outcomes in a number of
oncology indications. They are five compounds in various stages of development that are focused in
solid tumors with high unmet medical needs. The Abraxis pipeline expands and is very complementary
to our ongoing R&D efforts in solid tumor cancers. In a few minutes, you will hear directly from
Patrick on the technology platform and product pipeline.
ABRAXANE is a solvent-free chemotherapy treatment option for patients with metastatic breast cancer
which was developed using Abraxis proprietary nab technology platform. This unique delivery
mechanism enables higher concentrations of the active agent to reach the tumor site. ABRAXANE
compared to paclitaxel has improved patient outcomes for both breast and
lung cancer patients. Importantly, the compound has demonstrated impresive early data in pancreatic cancer
and there is a robust clinical program in other solid tunors including melanoma and bladder cancer.
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FINAL TRANSCRIPT
Jun. 30. 2010 / 1:00PM, CELG Celgene Corp. Conference Call to Discuss Strategic Acquisition of Abraxis BioScience
The currently approved indication for ABRAXANE is metastatic breast cancer. ABRAXANE was approved
on the basis of superior response rate to paclitaxel. After longer follow-up, the data consistently
demonstrated ABRAXANEs superiority to paclitaxel across all key metrics, overall response rate,
time to disease progression, and overall survival. In the United States, ABRAXANE is the market
leader in taxane-based therapies treating metastatic breast cancer.
With the strength of the existing results as well as additional emerging data from ongoing Phase II
and Phase III trials in breast cancer, our combined efforts will be focused on reenergizing this
brand and delivering meaningful revenue growth beginning in 2011.
Non-small cell lung cancer remains a major unmet medical need. The treatment paradigm in this
setting has evolved to be histologically specific with the two major categories being squamous and
non-squamous. While platinum taxane doublets represent the leading regimen, major advancements to
the treatment of this disease have been limited to patients with non-squamous histology. The recent
approvals of newer drugs specifically exclude the squamous population which represents
approximately 30% of the market. Patients with squamous histology remain significantly underserved
and this represents a unique and substantial opportunity for ABRAXANE.
Data presented from the podium at this years ASCO just a few weeks ago reflected the significant
promise and growth opportunity for ABRAXANE in this indication.
The 1050-patient randomized Phase III registration study in advanced non-small cell lung cancer is
evaluating carboplatin plus ABRAXANE versus this regulatory standard, carboplatin plus paclitaxel.
Unlike the paclitaxel arm that required pre-medication, no pre-medication was required in the
ABRAXANE arm because of its solvent-free formulation.
The preliminary results presented at ASCO confirm ABRAXANEs superiority versus paclitaxel in this
patient population. The independently assessed overall response rate of 33% versus 25% with a p
value of 0.005 is a 31% improvement. This is the primary endpoint of a special protocol assessment
with the FDA.
Additionally, ABRAXANE plus carboplatin produced a clinically meaningful improvement in response
rate in the underserved segment of patients with squamous histology, with an overall response rate
of 41% versus 24%. This is a 67% improvement in response rate versus the reference standard.
The approved efficacy from ABRAXANE plus carboplatin was achieved with fewer dose-limiting
toxicities and a manageable side effect profile. Patients experienced less peripheral neuropathy
and neutropenia. For patients with non-small cell lung cancer, treatment with ABRAXANE and
carboplatin is very patient-friendly with a shorter infusion time and without side effects from
required pre-medication.
Among the major solid tumor cancers, patients with pancreatic cancer had the fewest therapeutic
options and among the poorest outcomes. The median survival for patients receiving currently
available therapies is just six months and there have been very few meaningful advances in the
treatment of this disease. In the US, there are approximately 32,000 patients with unresectable
disease and the standard of care for these patients is gemcitabine.
Theres a strong biologic rationale for the use of ABRAXANE in combination with gemcitabine in
patients with advanced pancreatic cancer. ABRAXANE is taken up preferentially by tumors through the
endothelium via the SPARC, the secreted protein acidic and rich in [cito] cysteine protein that is
over expressed in pancreatic cancer and associated with a poor prognosis. 67 patients with
metastatic pancreatic cancer were treated in a Phase I/II study with ABRAXANE in combination with
gemcitabine. This novel combination produced an overall response rate of 46%, which is nearly four
times that of historical controls.
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FINAL TRANSCRIPT
Jun. 30. 2010 / 1:00PM, CELG Celgene Corp. Conference Call to Discuss Strategic Acquisition of Abraxis BioScience
The preliminary survival results is perhaps even more impressive as median survival more than
doubled from six months versus historical controls with 12 months in this study.
The PET Scan analysis complete response rate in the combination was 13%, which is more than the
overall response rate in other gemcitabine-based regimens.
This PET Scan, this image of a PET Scan in a patient before and after two cycles of gemcitabine and
ABRAXANE. In a PET Scan, tumors show up as black spots. In the image on the left side, you can see
the primary tumor in the center of the patient is surrounded by extensive metastases in the
abdomen, pelvis, and liver. In the scan on the right, which was obtained after two treatment
cycles, the tumors have disappeared and the scan was read by independent reviewers as a normal PET
Scan.
Based upon the results of the I/II Phase I/II, Abraxis is aggressively conducting a Phase III trial
designed to produce data for global regulatory review. The study is already more than one third of
the way accrued. We believe that data will be available at the beginning of 2013.
We believe that this transaction will create significant value. We will be focused on maximizing
the full potential of ABRAXANE, beginning with the reenergizing of the US efforts in metastatic
breast cancer. Our teams will expeditiously complete the SBA trial in lung cancer that has already
met its primary endpoint of response. Our objective will be upon completion of the trial to prepare
the data for filing in as many markets as appropriate depending on the data. We will also look for
all means of accelerating the completion of the Phase III pancreatic trial. We will develop global
plans for ABRAXANE in this indication as we review the data and prepare for regulatory filings.
It is our view that issued and pending patents and manufacturing knowledge provide for exclusivity
until 2023 and potentially beyond for ABRAXANE. Executing this plan will create significant value
and afford us the potential to grow ABRAXANE to $1 billion in revenue in 2015 with up to an
additional $1 per share in non-GAAP EPS. We expect the transaction to be slightly dilutive in 2011,
maybe as much as $0.10, but accretive in 2012. And this it is our clear expectation that this
transaction will return produce returns in excess clearly of our cost of capital.
Let me now turn the call over to Patrick for his perspective.
Patrick Soon-Shiong Abraxis BioScience, Inc. Executive Chairman
Thank you, Bob. It is really a distinct pleasure to be with you on this call this morning. So Bob
and Sol have discussed this potential of ABRAXANE and I would maybe like to discuss the science
that makes ABRAXANE possible as well as the underlying nab or nano particle albumin-bound
technology that can be used to develop this deep product pipeline with applications in multiple
difficult to treat solid tumors.
At the recent ASCO in Chicago, we presented more than 32 scientific abstracts which evaluated the
use of nab-based anti-cancer therapy. We are very excited by this paradigm, which may be applicable
to multiple difficult to treat tumor types and we presented data both at ASCO and AACR which
covered triple negative breast cancer, metastatic pancreatic cancer, non-small cell lung cancer
including the results that Bob talked about in squamous cell lung cancer, metastatic melanoma, and
invasive bladder cancer.
Importantly we are now improving our understanding of how exactly this nab-driven drug delivery
mechanism works when administered either as a single agent or when given in combination. And the
implications of the mechanism of action is that ABRAXANE could truly become the backbone of all
combination therapies.
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FINAL TRANSCRIPT
Jun. 30. 2010 / 1:00PM, CELG Celgene Corp. Conference Call to Discuss Strategic Acquisition of Abraxis BioScience
We in Phase I/II clinical trials now other than ABRAXANE with multiple other drugs in the pipeline
including docetaxel, rapamycin, [simgin AG], a (inaudible) protein inhibitor and a vascular
disrupting agent, and I will be spending a little bit of time reviewing those drugs in the pipeline
very shortly.
But turning back now to this nab-driven chemotherapy, this nab-driven chemotherapy we believe
provides a new paradigm for penetrating the blood stromal barrier to reach the tumor cell and the
proposed mechanism of delivery of this nab-driven chemotherapy is thought to be by targeting a
previously unrecognized tumor-activated albumin-specific biological pathway with a nano shell of
human blood protein albumin. This nano shuttle system is believed to activate this albumin-specific
receptor-mediated transcytosis pathway in which the shuttle is carried through the cell wall of
[proliferating] tumor cells. In so doing it reaches the stromal microenvironment and the
albumin-bound drug may then preferentially be localized by a second albumin-specific binding
protein called SPARC, which is secreted into the stroma by these tumor cells.
The resulting collapse of the stroma surrounding the tumor cell may thus enhance the delivery of
not only the nab chemotherapeutic but together with any chemotherapy given in combination with the
intracellular core of the tumor itself. And this previously unrecognized tumor-activated pathway we
believe is the backbone of our technology.
So this platform for the treatment of solid tumors truly complements Celgenes enormous success in
liquid tumor therapy with its REVLIMID and VIDAZA platforms. Celgene has demonstrated tremendous
operational ability to market and distribute its drugs on a global scale and is the worlds leading
tumor oncology company. So to address the question why now and why Celgene, by combining Celgene
and Abraxis, we believe we will create an enterprise that far exceeds the sum of the parts.
The combined entity will be able to leverage the many complementary strengths of the liquid and
solid platforms in advance, a collective passion for improving cancer patient care worldwide
through innovative science. We believe in the ongoing value of ABRAXANE as well as the research,
science, and operational excellence of Celgene together will maximize the delivery of ABRAXANE to
cancer patients. This combination of the nab technology platform with Celgene science and global
market strength I believe will result in the worlds leading oncology company that will change the
way we treat cancer patients globally.
I believe so strongly in this combination that I felt compelled as part of the transaction to
commit to a significant stake in Celgene stock. Sol and Bob and team are clearly driven by their
passion to improve patient quality of life and the belief that the science will prevail, which in
fact it has at Celgene. Theyve built an amazing organization that has transformed the treatment of
liquid tumors while developing exceptional clinical and operating capabilities in the United
States, Europe, and Japan, and I believe that the commitment of Celgene to science and innovation
will drive long-term growth and shareholder value.
This was why I believe in taking a stake in the Company and I am honored to be part of the vision
and foundation that Sol and Bob have built and will continue to build.
Let me turn to the slide with regard to the pipeline and give a brief overview of the very deep
pipeline covered by the nab or nano particle albumin-bound platform. Firstly, as you could see and
discussed, ABRAXANE itself is a pipeline within itself with indications in breast cancer,
metastatic cancer, first line, second line, and third line, for which it has now been approved in
second line, but there have been clinical trials in which the first-line therapy has been shown
even against Taxotere.
The lung cancer trial is well into Phase III, and has been discussed by Bob, and so is the
metastatic melanoma trial as well as the pancreatic trial. And the recent data that has just been
presented as a late breaker by the American Association of Urology has demonstrated very exciting
results in recurrent invasive bladder cancer.
Let me turn to the pipeline itself, firstly nab docetaxel, which is ABI 008. Interestingly, the
advantages seen with nab paclitaxel over Cremophor paclitaxel were also observed preclinically for
nab docetaxel over tween docetaxel. This drug is now in clinical trial and we received approval
with regard to the regulatory strategy, i.e., the similar regulatory strategy for ABRAXANE, a
505(b)(2) approval status, and we are now in Phase I/II trials in patients with hormone refractory
prostate cancer. And the Phase II trial is ongoing as we speak.
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FINAL TRANSCRIPT
Jun. 30. 2010 / 1:00PM, CELG Celgene Corp. Conference Call to Discuss Strategic Acquisition of Abraxis BioScience
The second drug in the pipeline, ABI 009 or nab rapamycin attacks the biological target of mTOR.
Now mTOR is an important survival pathway in cancer cells and the drugs that are currently approved
for renal cell carcinoma attacking this pathway, temsirolimus (inaudible), and interestingly we
have demonstrated at least preclinically potential advantages of temsirolimus.
Firstly, theres no premedication required. Secondly, interesting with regard to temsirolimus, the
dose response may be affected by its potential saturation of the enzyme for this prodrug conversion
of temsirolimus. The mTOR pathway and its [cellular] targets are many and the combination therapies
are well established in the preclinical literature.
An interesting result that just has been presented very recently is the combination of nab
rapamycin or ABI 009 with perifosine in the treatment in multiple myeloma. We are now in Phase I
clinical trials in multiple solid tumors, which includes renal cell carcinoma and sarcomatoid
mesothelioma. That Phase I trial is ongoing.
The next drug in the pipeline taking advantage of this nab-driven chemotherapy is ABI 0011 or nab
544. This is a novel vascular disrupting agent with dual activity on both tubulin and
topoisomerase-1 and preclinically has been demonstrated to be more active than irinotecan in colon
cancers. This drug has now been achieved IND status and the Phase I clinical trial is about to
be approved and to be launched again in solid tumors.
The next drug on the pipeline is ABI-013 or nab CY196 and this is a novel hydrophobic taxane, and
it is a docetaxel prodrug with a rational design and is really has been designed for the first time
to maximize transport (inaudible) in their pathways. And this drug at least in the preclinical
status has now been shown to have more active be more active than Taxotere, and we anticipate
the IND to be filed this year.
Then finally, nab-17-AAG or ABI-010, which is a novel nano particle version of the heat shock
protein 90 inhibitor 17-AAG and as maybe many of you may know, 17-AAG is an important biological
target. And 17-AAG has been shown to suppress HER2 expression in breast carcinoma cell life.
What is also of interest however is that 17-AAG in the Cremophor formulation is now in Phase III
trials under BMS for multiple myeloma and is also in Phase I and II trials in combination with
Herceptin in breast cancer. Our nab-17-AAG will now enter into our Phase I trial and has very
strong intellectual property protection all the way to 2026.
So with that background of the pipeline, I would like to say it has been it is really an honor
and an exciting time for our company to be part of the vision and foundation that Sol and Bob have
built.
With that brief overview, let me turn the call back to Bob.
Bob Hugin Celgene Corporation President and COO
Thanks very much, Patrick. We hope that you can sense the potential of this combination and its
our intention this morning to provide you information so that you can see the clarity and the
compelling rationale strategic fit of this transaction.
The acquisition of Abraxis is a natural evolution of our business model and extends our leadership
position in hematology and oncology. Working together, our combined teams of dedicated
professionals will create significant value for patients, physicians and shareholders. The addition
of ABRAXANE is a unique opportunity that enables us to expand into solid tumors and when combined
with our existing portfolio of products gives us a differentiated product offering that addresses
major diseases across hematology, solid tumor oncology, and immune inflammatory diseases.
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7
FINAL TRANSCRIPT
Jun. 30. 2010 / 1:00PM, CELG Celgene Corp. Conference Call to Discuss Strategic Acquisition of Abraxis BioScience
The acquisition broadens our revenue streams and gives us access to a potential blockbuster that
could add up to $1 billion in topline and will be highly accretive to earnings in 2012 and beyond.
Given the emerging ABRAXANE clinical data, the pipeline
of assets, the innovative science, Abraxis BioScience represents the right opportunity at the right
time, a compelling strategic acquisition that will enhance our market-leading growth.
So thank you for joining us on the call. Operator, we would like to open it up to questions.
QUESTIONS AND ANSWERS
Operator
(Operator Instructions) Brian Abrahams, Oppenheimer & Co.
Brian Abrahams Oppenheimer & Co. Analyst
Thanks very much for taking my question and congratulations on the deal. I wanted to drill down a
little bit more on your regulatory strategy in non-small cell lung cancer. By the time you file
with the FDA in the first half of next year, are you expecting to have PFS data? Are you planning
to file in all patients or just in the squamous population? If your plan is to file in all
patients, do you expect that the potential convenience and tolerability benefits would justify
premium pricing without efficacy superiority in the non-squamous patients or would you need to show
superior PFS for good adoption? Thanks.
Bob Hugin Celgene Corporation President and COO
It is quite a few points and questions in there and clearly as the trial is competed, as everyone
recognizes, the primary endpoint in the SPA agreement with the FDA has been met but the trial will
continue throughout the year and we will see the progression-free survival and potentially overall
survival results. So depending on the results, that will influence and lead us down a specific
regulatory pathway.
And if we see the kind of PFS data that we are hopeful we will see, that will open up international
markets for this indication and with that data we do believe that the value proposition would be
sufficient to get us the kind of pharmacoeconomic and health technology assessments that would
allow us to ensure that we have access to global markets across the world. But again in the US, the
SPA is based on response and weve completed the Company, Abraxis has completed that and
succeeded to achieve that primary endpoint, but obviously the more compelling data you have, the
better it is for us both from a regulatory pricing and reimbursement.
But from a filing point of view, we do expect that the filing will be a broad indication and the
data in the package may be specific to certain subsets that will be able to be amplified. But the
actual label itself is designed to be for the full approval.
Operator
Yaron Werber, Citi.
Yaron Werber Citigroup Analyst
Congrats on the deal. I have a question on pricing. Theres some concerns that the price has been a
barrier or the historical price increases have been a barrier to adoption. But when we look at the
historical price increases, there have essentially been about 1% every seven or eight months, kind
of going back to November 2008. So can you help us understand a little bit, has price been an
issue? It sounds to us like management guided the sales of about $300 million this year, which is
actually down year-over-year. Im just trying to understand the pricing strategy and how it has
impacted sales historically. Thanks.
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FINAL TRANSCRIPT
Jun. 30. 2010 / 1:00PM, CELG Celgene Corp. Conference Call to Discuss Strategic Acquisition of Abraxis BioScience
Bob Hugin Celgene Corporation President and COO
Its a good question. Its very important and I think theres a couple of important considerations
here. First, we obviously will submit for Hart-Scott-Rodino clearance in the US and any other
markets that we require in regulatory clearance before we actually begin to integrate and
consolidate plans on it. So that weve got to make sure we do that first and foremost. But once we
get through that, I think that our position at Celgene has been a very clear one, that when you
look at the performance of a drug and the benefits to ensure that you have the broadest market
access for a drug, you need to have the right value proposition. Thats a combination most
importantly of clinical data.
Price is clearly an important component of that so I dont think that once we are in the position
to be very intimately involved we will look at each market, look at each indication, look at the
value proposition, ensure that the clinical data is positioned in discussions with payers, whether
that be in the United States or all around the world to ensure that we have the most convincing
value proposition first and foremost based on the clinical data and then obviously the price. So I
think price certainly does have an important consideration in peoples decisions, but really in the
end, its that we believe here ABRAXANE has clinically meaningfully differentiated results over
competitive therapies that we dont believe have been fully recognized by payers and we think that
were hopeful we will be able to do an effective job to support the Abraxis existing team with our
team to ensure that we make that compelling case.
And clearly as additional data comes in non-small cell lung cancer, in pancreatic cancer, hopefully
bladder cancer and a wide range of other solid tumors, we need to ensure that value proposition.
Those negotiations with health technology assessment agencies, pharmacoeconomics put ABRAXANE in
the right light and ensure that the relationship with payers is one of constructive and positive
ones that ensures the maximum number of patients access to the therapy.
Operator
Geoff Meacham, JPMorgan.
Geoff Meacham JPMorgan Analyst
Thanks for taking the question. Kind of a multipart question here. Can you talk about your
commercial strategy in Europe for ABRAXANE in breast cancer and maybe go over the contribution from
Europe in the first quarter? And then a real quick question, does your $1 billion and 2015
revenues, does that assume that you do in fact have PFS for lung cancer and OS for pancreatic
cancer? Thanks.
Bob Hugin Celgene Corporation President and COO
A couple of questions there. First, the European strategy, again, we are giving you our perspective
in advance of integration and full knowledge from the Abraxis team. So we certainly have a strong
perspective. Were also going to very much following the Hart-Scott-Rodino, the antitrust
review, that were going to work closely with the team at Abraxis that has positioned ABRAXANE to
where it is today.
In Europe specifically, our perspective is that we would look for additional data in lung cancer,
pancreatic cancer before we would begin a major global expansion of ABRAXANE in Europe in any case.
So thats first and foremost. The second part of the question was ?
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FINAL TRANSCRIPT
Jun. 30. 2010 / 1:00PM, CELG Celgene Corp. Conference Call to Discuss Strategic Acquisition of Abraxis BioScience
Geoff Meacham JPMorgan Analyst
The contribution from Europe in the first quarter for ABRAXANE? And then the follow-up is does the
$1 billion and 2015 revenues, does that in fact assume that you hit PFS in lung and OS in
pancreatic?
Bob Hugin Celgene Corporation President and COO
So first, I dont know the details of it but our understanding is that Europe had a very minimal
impact on the results of the first quarter for ABRAXANE. And then in the US for the $1 billion
number, we really have a number of different scenarios that lead to that. Its not just one
specific scenario. We look at different scenarios and we have a composite of them to come to the
conclusion, but we dont particularly have the PFS assumption in that $1 billion number in the base
case that leads to that.
We do have scenarios where we do have PFS in and dont have other things, but the base case in our
number there that we talked about this morning does not include PFS in lung cancer in that data.
Operator
Chris Raymond, Robert Baird.
Chris Raymond Robert W. Baird Analyst
Thank you. For taking the question. Just a question for Bob on the IP, or Patrick. Bob, you
mentioned in your prepared comments IP protection at 2023, I think and beyond. Again, this may be
something thats better known, but in the latest 10-K it references 2018 with some pending IP. Can
you maybe put some color around what is pending or if theres something thats changed that is more
solid? That would be great, thanks.
Bob Hugin Celgene Corporation President and COO
Yes, I think its a very important point because the exclusivity of ABRAXANE has tremendous upside
even from the discussion that we have had here today and we view intellectual property and
exclusivity as certainly so fundamental critical to the success of a company like Celgene, and our
work in the due diligence was highly focused on the exclusivity both from manufacturing, from a
wide range of patents and pending patents etc. And I dont we cant go into specific details on
specific patents, but I can tell you that when we think about the transaction itself and what drove
us to say the timing is now is that one, the pancreatic data, the lung cancer data, the timing of
that data and the opportunity to influence and to impact the plans for that over the coming years
so that we can have the maximum impact when that data is available and can be leveraged, but also
the exclusivity.
We think that the timing of the strategy of Abraxis for extending the exclusivity is reaching a
great promise and success in what they have already done. So we think the two elements are the
data, but also extensive work on the exclusivity. Clearly theres always risks in this area, but we
would not be doing this deal today if we did not have a strong conviction that the regulatory
patent exclusivity of the compound is better than we had thought a few months ago.
Operator
Geoffrey Porges, Bernstein.
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FINAL TRANSCRIPT
Jun. 30. 2010 / 1:00PM, CELG Celgene Corp. Conference Call to Discuss Strategic Acquisition of Abraxis BioScience
Geoffrey Porges Sanford Bernstein Analyst
Thanks very much. I just wanted to sort of go through the basis for this being accretive in 2011.
Its not immediately obvious where that will come from, so Im wondering if you could talk us
through, Dave, perhaps about what of your current plans at Celgene you may not engage in as a
result of this transaction? And then also what if any savings you would envisage from the merger of
the two companies?
And then perhaps a little bit about when you might start working together. It is clear there are a
lot of priorities in what youve said, Bob, about areas that you would focus on, but is that
something that is not going to happen until 2011 or would the organizations start working together
earlier in the year? Thanks.
Dave Gryska Celgene Corporation SVP and CFO
Geoff, just to clarify, in Bobs prepared remarks, he mentioned that there would be accretion in
2012. You mentioned 2011. We mentioned mild dilution or slight dilution in 2011 of about $0.10.
Geoffrey Porges Sanford Bernstein Analyst
Yes, so I meant 2012, sorry.
Dave Gryska Celgene Corporation SVP and CFO
I just wanted to correct that point. The next point is that we have only assumed some minor
synergies in the combination, so obviously we have to work through that down the road. The teams
cannot work together, obviously, until after weve cleared the HSR process and get through the S4
process and so forth and so on. So our view is that we are going to go forward with all the
programs we talked about in R&D Day, which you were at, move those forward and obviously move the
projects forward at Abraxis in addition to that. And again with only minor synergies assumed in
this combination.
Bob Hugin Celgene Corporation President and COO
We will see accelerating accretion as the years go on, but certainly we are confident that 2012
will be accretive.
Dave Gryska Celgene Corporation SVP and CFO
And to be clear also in 2010 is there will be no change in our estimate that we gave in the last
quarter in terms of EPS.
Bob Hugin Celgene Corporation President and COO
And let us be clear that the numbers we are speaking of today really leave any synergies as upside
to the financial outcome.
Operator
Mark Schoenbaum, ISI.
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FINAL TRANSCRIPT
Jun. 30. 2010 / 1:00PM, CELG Celgene Corp. Conference Call to Discuss Strategic Acquisition of Abraxis BioScience
Mark Schoenbaum ISI Group Analyst
Thanks for taking the question. Just building on Geoffs question, can maybe Patrick, can you tell
us how big the current ABRAXANE sales force is in the US, if thats something that youve released?
And then for Dave, these CVR payments, are these going to come out of non-GAAP or GAAP? Are these
going to be recorded as a non-GAAP charge going forward?
Dave Gryska Celgene Corporation SVP and CFO
Let me start first and Patrick can answer the second part, so Im going to go in reverse order
here. First of all, the CVR payments or the CVRs will be registered on a Form S4 at the same time
that we do our stock this summer, so there will be registered securities that will be out there and
essentially that will be a non-GAAP reconciling item. So it will not come out of any GAAP earnings
when that eventual event occurs in the future. All right?
Mark Schoenbaum ISI Group Analyst
Okay. Thank you.
Operator
Jim Birchenough, Barclays Capital.
Jim Birchenough Barclays Capital Analyst
Just a question on a relative use of cash here, and I guess Im looking for a bit of an
explanation. If I look at the $2.9 billion in cash here, maybe how do we look at this as being
better used acquiring Abraxis as opposed to buying back Celgene shares? In answering that, maybe
you could address how you look at the relative growth prospects for ABRAXANE versus REVLIMID and
the margins that you expect to get to with the addition of ABRAXANE to your portfolio? Thanks.
Bob Hugin Celgene Corporation President and COO
I will give you maybe a couple of us will give you insight. I think first of all, we do believe
this transaction has the potential to actually be accretive to our growth. So we dont see this
portfolio and this product as doing anything but enhancing our growth profile both on the top line
and the bottom line. So we think from a strategic point of view our opportunity and leverage to
expand our capabilities in hematological cancers into solid tumors opens up a number of
opportunities for us to leverage and have a greater impact.
And the specifics of this transaction we think are no better use of our resources than where we can
produce significant revenue growth in line with the very, very high revenue growth that our
existing portfolio has and to augment the earnings per share growth. So we think this deal fits on
all metrics of valuation from strategy, from financial, for people purposes, and for cultural and
intangibles that can produce benefits over the long-term.
Dave Gryska Celgene Corporation SVP and CFO
In addition to that, we expected that in 2011 with the combination that we will have over $1
billion of free cash flow and by the time we hit 2014, we will have a number thats approaching $3
billion in free cash flow with the combined companies, so we view this as very synergistic down the
road. Obviously there will be a lot of operating leverage. Our gross margins will be maintained on
a go-forward basis as we put the combined companies together. So we see this as a big upside and
value driver for our shareholders.
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FINAL TRANSCRIPT
Jun. 30. 2010 / 1:00PM, CELG Celgene Corp. Conference Call to Discuss Strategic Acquisition of Abraxis BioScience
Jim Birchenough Barclays Capital Analyst
Just can I just follow up on that? I just want to understand what youre saying is that you
expect ABRAXANE to grow at a commensurate rate to REVLIMID and to generate comparable operating
margins. Is that right?
Dave Gryska Celgene Corporation SVP and CFO
Yes, that is right.
Jim Birchenough Barclays Capital Analyst
And just in making that assumption, I am wondering what contribution you think pancreatic needs to
make to get to that assumption and how you think about the folfirinox data at ASCO in terms of the
bar the new bar that has been set for pancreatic? Thanks.
Bob Hugin Celgene Corporation President and COO
Yes, I think theres a number of different scenarios that we look at that get to the growth
projections we have. Pancreatic is certainly a part of that and we think that if the data is in the
Phase III, as we are optimistic it will be, it will compete extremely effectively and be a very
valuable resource for the treatment of pancreatic cancer. Unfortunately we think there are going to
be need for multiple therapies to deal with pancreatic cancer. But we feel very good about what the
standard of care is going to be and if the data is what we think it will be, it will become the
standard of care.
Operator
Jason Kantor, RBC Capital Markets.
Jason Kantor RBC Capital Markets Analyst
Thank you for taking my question and also congratulations. I wonder if you can go back and answer
the question, which I dont think you did, which was on the size of the ABRAXANE sales force? And
also is there any potential for this sales force to enhance either near-term or longer-term sales
of REVLIMID or any of your other products?
Bob Hugin Celgene Corporation President and COO
Jason, weve just been advised that the questions should be answered by Celgene, and our
understanding and our efforts in our research here and the work with Abraxis, about 100 people
headquartered in Bridgewater, New Jersey and that post the HSR review, we will look to leverage the
best of what we have and what Abraxis has to make sure that were making the maximum for ABRAXANE
in the United States. We are in the very fortunate position that at Celgene already weve got a
number of people, I think more than 50% of our existing commercial field force has solid tumor
cancer experience.
So in combination with things we are doing over time with the organization, we think there will be
good synergies and we think there will be no lessening of the commercial impact in terms of numbers
and resources, but there will certainly be a strengthening of it.
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Jun. 30. 2010 / 1:00PM, CELG Celgene Corp. Conference Call to Discuss Strategic Acquisition of Abraxis BioScience
Operator
Mike King, Wedbush.
Mike King Wedbush Analyst
Let me also add my congratulations to both parties. I wonder if I could turn the question that
folks were asking about Europe around and perhaps ask Celgene. Can you talk about the
infrastructure, the sales infrastructure in Europe and ex-US markets and perhaps what incremental
investment you think you need to make in that market to make ABRAXANE a success over there?
Bob Hugin Celgene Corporation President and COO
Yes, I think that our perspective is that in Europe that as we get new data and begin what will be
really the launch of ABRAXANE, it will be through the Celgene organization that the limited
resources that are there today are not designed to have a full commercial launch that well be able
to do. Other markets, where China and other markets where ABRAXANE Abraxis is more advanced than
Celgene we will likely use their resources to help us accelerate REVLIMID in those markets,
specifically China. So we think theres opportunities on the commercial side globally for Abraxis
organization to help us and that we will significantly make an impact internationally in most
markets.
Operator
Gene Mack, Soleil Securities.
Gene Mack Soleil Securities Analyst
Thanks for taking the question. I wonder, Bob, if you could just follow up a little bit on the
patent estate and just ask for a little bit more clarification. On the FDAs Orange book it looks
like there are some things that expire in 2013 and as was pointed out earlier in the 10-K for
Abraxis points to 2018 and then you mentioned 2023 and that there was some timing that was
particularly important. So can you just maybe go through what sort of each of those what sort of
protection kind of goes to those time durations, 2013, 2018, 2023?
And it sounds as though there might have been some patents that were just recently issued based on
the way you described the timing and if thats the case, can you give us a little bit more detail
on that?
Bob Hugin Celgene Corporation President and COO
You know, its a challenging subject in terms of getting into specifics about issues that are
sensitive like this, and I think that hopefully over time we will be able to provide more clarity
on the strategy. I think one of the things thats very clear in terms of one of the real
confidences between Abraxis BioScience and Celgene is the very, very focused management approach to
exclusivity, patent protection, intellectual property generally. And I think that the strategy that
the Abraxis leadership has taken to really build an extensive intellectual property portfolio and
exclusivity opportunities around ABRAXANE and the entire nab technology platform is in my opinion
underappreciated in the marketplace, and certainly that again, as I mentioned, was a major focus of
our work. Clearly its an important area and again, to go into specifics before the deal closes is
not something that is prudent for us to do, certainly not in advance of regulatory review.
But I can only tell you that it was a major focus and we do believe there is reasonable strength
that gives us the conviction that we believe we will have extended exclusivity to 2023 and
potentially beyond.
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FINAL TRANSCRIPT
Jun. 30. 2010 / 1:00PM, CELG Celgene Corp. Conference Call to Discuss Strategic Acquisition of Abraxis BioScience
Operator
Ian Somaiya, Piper Jaffray.
Ian Somaiya Piper Jaffray Analyst
Thanks for taking my question. I guess I will add my congratulations to both parties as well. I
just wanted to make sure that I understood, you guys have been fairly judicious in your spending in
the past. What does this acquisition mean for current Celgene portfolio in terms of the Companys
ability to fund development. Tax structure and expanding European operations has any beneficial
effect on the tax structure going forward, and whether theres any opportunity to apply the nab
technology to Celgenes existing products such as VIDAZA?
Bob Hugin Celgene Corporation President and COO
Well, we certainly and I hope you could sense from Patricks comments that there is the
potential for a lot of work to be done to really look for ways to ensure that the new Celgene
really capitalizes on the full potential of the science, the research, the pipeline, the platform
at Abraxis, and that will be an important part of the scientific strategy here, the research
strategy going forward.
I do want to make sure that we do emphasize a couple of points and I tried to make it earlier as to
why now. I think that the clinical data, the opportunity to influence the progress of that is
critical to us. The exclusivity issues we think will become more clear as to the confidence that we
have in the extended exclusivity, and also its really time for us to accelerate our momentum.
As weve discussed 2009 was a great year for Celgene. 2010 was a spectacular quarter and leading us
to increase our guidance for the year. As weve mentioned earlier, this quarter is very much on
track and we are very much looking forward on July 29 to update you the specifics of the results of
this quarter. And we think this is an opportunity for us to really say out of strength lets now
make the move into solid tumor cancer and leverage the successes weve had, leverage the people we
have. We are very excited about the potential of what Patrick, his team, and the professionals at
Abraxis bring to Celgene, and we are just going to aggressively go through the regulatory process,
get this transaction closed as rapidly as possible so we can begin to demonstrate the merits and
the benefits of bringing these companies together.
So thank you, everyone, for coming together on very short notice. We are very excited and
optimistic about what this transaction means to patients, what it means to Celgene and certainly to
our shareholders. Again, look forward to meeting you in the coming weeks, so we do have a quiet
period to deal with, and that we will have a conference call on the 29th to update you.
One last thing, we want to make sure everyone understands that we have really think the
relationship that we are building with Patrick specifically and the leadership of Abraxis only
portends great things for this combination. So thank you, Patrick, and thank you, everyone, for
participating.
Patrick Soon-Shiong Abraxis BioScience, Inc. Executive Chairman
Thank you very much, Bob.
Operator
Ladies and gentlemen, this does conclude todays program. You may now disconnect and have a
wonderful day.
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FINAL TRANSCRIPT
Jun. 30. 2010 / 1:00PM, CELG Celgene Corp. Conference Call to Discuss Strategic Acquisition of Abraxis BioScience
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