-- Gilead Adds TrodelvyTM, First-in-Class
Antibody-Drug Conjugate Approved to Treat Triple-Negative Breast
Cancer, With Promise in Other Forms of Breast Cancer and
Additional Solid Tumors --
-- Acquisition Transforms Gilead’s Portfolio
with First-in-Class Commercial Product with Significant Revenue and
Best-in-Class Potential --
-- Trodelvy will Accelerate Gilead’s
Emerging and Complementary Oncology Pipeline, Building on
Agreements Executed Earlier This Year --
-- Immunomedics to Present Latest Clinical
Findings on Trodelvy at European Society for Medical Oncology
Virtual Congress 2020 This Coming Week --
Gilead Sciences, Inc. (Nasdaq: GILD) and Immunomedics (Nasdaq:
IMMU) announced today that the companies have entered into a
definitive agreement pursuant to which Gilead will acquire
Immunomedics for $88.00 per share in cash. The transaction, which
values Immunomedics at approximately $21 billion, was unanimously
approved by both the Gilead and Immunomedics Boards of Directors
and is anticipated to close during the fourth quarter of 2020.
This press release features multimedia. View
the full release here:
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The agreement will provide Gilead with TrodelvyTM (sacituzumab
govitecan-hziy), a first-in-class Trop-2 directed antibody-drug
conjugate (ADC) that was granted accelerated approval by the U.S.
Food and Drug Administration (FDA) in April for the treatment of
adult patients with metastatic triple-negative breast cancer
(mTNBC) who have received at least two prior therapies for
metastatic disease. Immunomedics plans to submit a supplemental
Biologics License Application (BLA) to support full approval of
Trodelvy in the United States in the fourth quarter of 2020.
Immunomedics is also on track to file for regulatory approval in
Europe in the first half of 2021.
In the Phase 3 ASCENT study, which was halted early due to
efficacy based on the unanimous recommendation of the independent
Data Safety Monitoring Committee, Trodelvy significantly improved
progression-free survival (PFS) and overall survival (OS) in
previously treated patients with advanced mTNBC. Detailed results
from this study are expected to be presented at the upcoming
European Society for Medical Oncology (ESMO) Virtual Congress
2020.
Beyond mTNBC, Trodelvy is also being studied in an ongoing Phase
3 trial in third line HR+/HER2- breast cancer and a registrational
Phase 2 study in bladder cancer. Additional ongoing studies are
evaluating the potential of Trodelvy as a treatment for non-small
cell lung cancer and other solid tumor types. Trodelvy is being
studied as both a monotherapy and in combination with checkpoint
inhibitors and other non-immuno-oncology products by Immunomedics
and independent investigators. Additional clinical data for
Trodelvy in bladder cancer and other solid tumors will also be
presented at ESMO this coming week.
“This acquisition represents significant progress in Gilead’s
work to build a strong and diverse oncology portfolio. Trodelvy is
an approved, transformational medicine for a form of cancer that is
particularly challenging to treat. We will now continue to explore
its potential to treat many other types of cancer, both as a
monotherapy and in combination with other treatments,” said Daniel
O’Day, Chairman and Chief Executive Officer, Gilead Sciences. “We
look forward to welcoming the talented Immunomedics team to Gilead
so we can continue to advance this important new medicine for the
benefit of patients with cancer worldwide.”
“We are very pleased that Gilead recognized the value of
Trodelvy – both for the important role it has already begun to play
for patients with metastatic triple-negative breast cancer and for
its potential to help many other patients with cancer in the
future,” said Behzad Aghazadeh, PhD, Executive Chairman of
Immunomedics. “We are excited for the opportunities ahead of us as
we join with Gilead to advance our shared mission in defeating
cancer. By working with Gilead, we have the opportunity to
accelerate our progress and improve care for patients in need of
new therapies.”
Compelling Strategic
Benefits
- Rapidly Expanding Trodelvy’s Benefit for Patients
Globally: After closing Gilead intends to initiate numerous
additional mid- and late-stage studies in the near term to
determine which patients will benefit from Trodelvy as both a
monotherapy or in combination with other products. Gilead brings
commercial, medical, regulatory and manufacturing expertise, which
will help rapidly advance Trodelvy through development and reach
additional patients. Gilead will also bring to Immunomedics an
established infrastructure and operations in Europe and Japan to
support the launch of Trodelvy in those regions, pending approval.
After closing, Gilead will retain global rights to Trodelvy outside
of greater China, South Korea and certain Southeast Asian
countries.
- Trodelvy is Foundational to Gilead’s Oncology Franchise:
Trodelvy will bring to Gilead a cornerstone product that broadens
and deepens the company’s solid tumor pipeline, building on current
marketed products and late-stage clinical candidates for patients
with hematological malignancies at Kite and Gilead, including
Yescarta®, Tecartus® and magrolimab. Trodelvy is approved as a
third-line treatment for mTNBC and has shown promise for earlier
stages of the disease. TNBC represents approximately 15 to 20
percent of all breast cancer cases and is generally considered the
most aggressive form of breast cancer. HR+/HER2- breast cancer
accounts for more than 70 percent of all breast cancers.
- Accelerates Gilead’s Revenue and EPS Growth: Trodelvy
was launched in May of 2020 and has significant commercial
potential in mTNBC and other solid tumors. In addition to
immediately accelerating Gilead’s revenue growth, the acquisition
of Immunomedics is expected to be neutral to accretive to Gilead’s
non-GAAP EPS in 2023 and significantly accretive thereafter.
Transaction Terms and
Financing
Under the terms of the merger agreement, a wholly-owned
subsidiary of Gilead will promptly commence a tender offer to
acquire all of the outstanding shares of Immunomedics’ common
stock. The $88.00 per share acquisition price represents a 108
percent premium to Immunomedics’ closing price on September 11,
2020. Following successful completion of the tender offer, Gilead
will acquire all remaining shares not tendered in the offer through
a second step merger at the same price as the tender offer.
The consummation of the tender offer is subject to various
conditions, including a minimum tender of at least a majority of
outstanding Immunomedics shares, the expiration or termination of
the waiting period under the Hart-Scott-Rodino Antitrust
Improvements Act and other customary conditions.
The tender offer is not subject to a financing condition and
will be funded through approximately $15 billion in cash on hand,
as well as approximately $6 billion in newly issued debt. Gilead
expects to retain an investment grade credit rating following this
transaction and this agreement does not alter Gilead’s stated
capital allocation strategy or its commitment to maintain and grow
its dividend over time.
Lazard and Morgan Stanley & Co. LLC are acting as financial
advisors to Gilead. Centerview Partners LLC and BofA Securities are
acting as financial advisors to Immunomedics. Cowen & Company,
LLC also provided advice to Immunomedics. Davis Polk & Wardwell
LLP is serving as legal counsel to Gilead and Watchell, Lipton,
Rosen & Katz is serving as legal counsel to Immunomedics.
Conference Call
At 5:00 p.m. Eastern Time today, Gilead's management will host a
conference call and a simultaneous webcast to discuss the
transaction. A live webcast of the call can be accessed at Gilead’s
Investors page at http://investors.gilead.com. Please connect to
the website at least 15 minutes prior to the start of the call to
allow adequate time for any software download that may be required.
Alternatively, please call 877-359-9508 (U.S.) or 224-357-2393
(international) and dial the conference ID 5776009 to access the
call.
Telephone replay will be available approximately two hours after
the call through 8:00 p.m. Eastern Time, September 15, 2020. To
access the replay, please call 855-859-2056 (U.S.) or 404-537-3406
(international) and dial the conference ID 5776009. The webcast
will be archived on www.gilead.com for one year.
About Trodelvy
Trodelvy (sacituzumab govitecan-hziy) is a Trop-2 directed
antibody-drug conjugate indicated for the treatment of adult
patients with metastatic triple-negative breast cancer (mTNBC) who
have received at least two prior therapies for metastatic disease.
This indication is approved under accelerated approval based on
tumor response rate and duration of response. Continued approval
for this indication may be contingent upon verification and
description of clinical benefit in confirmatory trials. To learn
more about TRODELVYTM (sacituzumab govitecan-hziy), please visit
https://www.trodelvy.com.
Trodelvy carries a black box warning for severe neutropenia and
severe diarrhea. The most common adverse reactions occurring in 25
or more percent of patients included nausea, neutropenia, diarrhea,
fatigue, anemia, vomiting, alopecia, constipation, decreased
appetite, rash and abdominal pain. The most common Grade 3 or 4
adverse events occurring in more than 5 percent of patients were
neutropenia, white blood cell count decreased, anemia,
hypophosphatemia, diarrhea, fatigue, nausea and vomiting. Two
percent of patients discontinued treatment due to adverse events.
There were no deaths related to treatment and no severe cases of
neuropathy or interstitial lung disease. See trodelvy.com for
additional U.S. important safety information and full Prescribing
Information, including Boxed Warning.
About Immunomedics
Immunomedics is a leader in next-generation antibody-drug
conjugate (ADC) technology, committed to help transform the lives
of people with hard-to-treat cancers. The company’s proprietary ADC
platform centers on using a novel linker that does not require an
enzyme to release the payload to deliver an active drug inside the
tumor cell and the tumor microenvironment, thereby producing a
bystander effect. Trodelvy, the company’s lead ADC, is the first
ADC the FDA has approved for the treatment of people with
metastatic triple-negative breast cancer and is also the first
FDA-approved anti-Trop-2 ADC. For additional information on the
Company, please visit its website at http://www.immunomedics.com.
The information on its website does not, however, form a part of
this press release.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical
company that discovers, develops and commercializes innovative
medicines in areas of unmet medical need. The company strives to
transform and simplify care for people with life-threatening
illnesses around the world. Gilead has operations in more than 35
countries worldwide, with headquarters in Foster City, California.
For more information on Gilead Sciences, please visit the company’s
website at www.gilead.com.
Forward-Looking
Statements
This communication contains forward-looking statements, within
the meaning of the Private Securities Litigation Reform Act of
1995, related to Gilead, Immunomedics and the acquisition of
Immunomedics by Gilead that are subject to risks, uncertainties and
other factors. All statements other than statements of historical
fact are statements that could be deemed forward-looking
statements, including all statements regarding the intent, belief
or current expectation of the companies’ and members of their
senior management team. Forward-looking statements include, without
limitation, statements regarding the business combination and
related matters, prospective performance and opportunities,
post-closing operations and the outlook for the companies’
businesses, including, without limitation, the ability of Gilead to
advance Immunomedics’ product pipeline and successfully
commercialize Trodelvy; expectations for achieving full U.S. Food
and Drug Administration approval based on Immunomedics’
confirmatory data for Trodelvy and Immunomedics’ development of
Trodelvy for additional indications; clinical trials (including the
anticipated timing of clinical data; the funding therefor,
anticipated patient enrollment, trial outcomes, timing or
associated costs); the possibility of unfavorable results from
clinical trials; regulatory applications and related timelines,
including the filing and approval timelines for Biologics License
Applications and supplements; filings and approvals relating to the
transaction; the expected timing of the completion of the
transaction; the ability to complete the transaction considering
the various closing conditions; difficulties or unanticipated
expenses in connection with integrating the companies; and any
assumptions underlying any of the foregoing. Investors are
cautioned that any such forward-looking statements are not
guarantees of future performance and involve risks and
uncertainties and are cautioned not to place undue reliance on
these forward-looking statements. Actual results may differ
materially from those currently anticipated due to a number of
risks and uncertainties. Risks and uncertainties that could cause
the actual results to differ from expectations contemplated by
forward-looking statements include: uncertainties as to the timing
of the tender offer and merger; uncertainties as to how many of
Immunomedics’ stockholders will tender their stock in the offer;
the possibility that competing offers will be made; the possibility
that various closing conditions for the transaction may not be
satisfied or waived, including that a governmental entity may
prohibit, delay or refuse to grant approval for the consummation of
the transaction; the effects of the transaction on relationships
with employees, other business partners or governmental entities;
the difficulty of predicting the timing or outcome of regulatory
approvals or actions, if any; Immunomedics’ ability to meet
post-approval compliance obligations (on topics including but not
limited to product quality, product distribution and supply chain
requirements, and promotional and marketing compliance); imposition
of significant post-approval regulatory requirements on
Immunomedics’ products, including a requirement for a post-approval
confirmatory clinical study, or failure to maintain (if received)
or obtain full regulatory approval for Immunomedics’ products due
to a failure to satisfy post-approval regulatory requirements, such
as the submission of sufficient data from a confirmatory clinical
study; the impact of competitive products and pricing; other
business effects, including the effects of industry, economic or
political conditions outside of the companies’ control; transaction
costs; actual or contingent liabilities; adverse impacts on
business, operating results or financial condition in the future
due to pandemics, epidemics or outbreaks, such as COVID-19; and
other risks and uncertainties detailed from time to time in the
companies’ periodic reports filed with the U.S. Securities and
Exchange Commission (the “SEC”), including current reports on Form
8-K, quarterly reports on Form 10-Q and annual reports on Form
10-K, as well as the Schedule 14D-9 to be filed by Immunomedics and
the Schedule TO and related tender offer documents to be filed by
Gilead and Maui Merger Sub, Inc., a wholly owned subsidiary of
Gilead. All forward-looking statements are based on information
currently available to Gilead and Immunomedics, and Gilead and
Immunomedics assume no obligation and disclaim any intent to update
any such forward-looking statements.
Additional Information and Where to
Find It
The tender offer described in this communication has not yet
commenced. This document is for informational purposes only and is
neither an offer to purchase nor a solicitation of an offer to sell
shares of Immunomedics, nor is it a substitute for any tender offer
materials that Gilead, Purchaser or Immunomedics will file with the
SEC. A solicitation and an offer to buy shares of Immunomedics will
be made only pursuant to an offer to purchase and related materials
that Gilead intends to file with the SEC. At the time the tender
offer is commenced, Gilead will file a Tender Offer Statement on
Schedule TO with the SEC, and Immunomedics will file a
Solicitation/Recommendation Statement on Schedule 14D-9 with the
SEC with respect to the tender offer. IMMUNOMEDICS’ STOCKHOLDERS
AND OTHER INVESTORS ARE URGED TO READ THE TENDER OFFER MATERIALS
(INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL
AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE
SOLICITATION/RECOMMENDATION STATEMENT BECAUSE THEY WILL CONTAIN
IMPORTANT INFORMATION WHICH SHOULD BE READ CAREFULLY BEFORE ANY
DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. The Offer to
Purchase, the related Letter of Transmittal and certain other
tender offer documents, as well as the Solicitation/Recommendation
Statement, will be sent to all stockholders of Immunomedics at no
expense to them. The Tender Offer Statement and the
Solicitation/Recommendation Statement will be made available for
free at the SEC’s web site at www.sec.gov. Additional copies may be
obtained for free by contacting Gilead or Immunomedics. Free copies
of these materials and certain other offering documents will be
made available by Gilead by mail to Gilead Sciences, Inc., 333
Lakeside Drive, Foster City, CA 94404, attention: Investor
Relations, by phone at 1-800-GILEAD-5 or 1-650-574-3000, or by
directing requests for such materials to the information agent for
the offer, which will be named in the Tender Offer Statement.
Copies of the documents filed with the SEC by Immunomedics will be
available free of charge under the “Investors” section of
Immunomedics’ internet website at Immunomedics.com.
In addition to the Offer to Purchase, the related Letter of
Transmittal and certain other tender offer documents, as well as
the Solicitation/Recommendation Statement, Gilead and Immunomedics
file annual, quarterly and current reports, proxy statements and
other information with the SEC. Gilead’s and Immunomedics’ filings
with the SEC are also available for free to the public from
commercial document-retrieval services and at the website
maintained by the SEC at www.sec.gov.
For more information on Gilead Sciences, please
visit the company’s website at www.gilead.com, follow Gilead on
Twitter (@GileadSciences) or call Gilead Public Affairs at
1-800-GILEAD-5 or 1-650-574-3000.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200913005051/en/
Gilead Contacts: Douglas Maffei, PhD, Investors (650)
522-2739 Amy Flood, Media (650) 522-5643
Immunomedics Contacts: Dr. Chau Cheng (862) 260-3727
ccheng@immunomedics.com Darren Opland, PhD, Media (646) 627-8387
darren@lifescipublicrelations.com
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