Ligand Pharmaceuticals Incorporated (NASDAQ: LGND)
provides a general corporate update, as follows:
“As the business environment has evolved in response to the
pandemic, Ligand has remained sharp with our operations and our
partners have been highly productive over the past few weeks,” said
John Higgins, Chief Executive Officer of Ligand Pharmaceuticals.
“Last week we completed an acquisition, we just signed a deal for a
novel FAAH inhibitor out of our Vernalis unit, two partners
recently closed important financings and over the past month
partners have begun additional COVID-19 initiatives. Our OmniAb®
business is advancing with a recent NDA filing in China and
positive Phase 2a data just announced. Notably, we are working to
ensure our Captisol® production meets the needs of our global
partners. Finally, despite the volatile capital markets, we have
used cash during the first quarter to buy back nearly a third of
our outstanding convertible bonds at what we believe were
attractive valuations.”
Follow Ligand on Twitter @Ligand_LGND.
OmniAb® Business Update
Ligand’s partners are actively progressing two OmniAb antibody
discovery programs for the potential treatment of COVID-19. One
multinational big pharma partner has initiated a program using
OmniChicken® and another partner is focused on antibodies derived
from OmniRat®.
Gloria Biosciences submitted an application for marketing
approval to the Chinese National Medicines Products Administration
for OmniAb-derived zimberelimab for the treatment of classical
Hodgkin lymphoma.
Immunovant announced positive results from its ongoing Phase 2a
proof-of-concept study of OmniAb-derived IMVT-1401 in thyroid eye
disease. IMVT-1401 is a novel investigational anti-FcRn antibody
delivered by subcutaneous injection. The results showed a 65% mean
reduction in total IgG observed from baseline to end of treatment,
with a pharmacodynamic response nearly identical to modeled
predictions for the dosing regimen tested in the trial. IMVT-1401
was generally well-tolerated.
Ligand’s partner Pandion Therapeutics closed an $80 million
financing on March 31, 2020 and announced that proceeds will
support the advancement of their pipeline of modular proteins and
bi-functional antibodies for the treatment of autoimmune diseases.
Ligand entered into an OmniAb Platform agreement with Pandion in
January 2020.
Captisol® Business Update
During the first quarter Ligand announced it is supplying
Captisol to partners evaluating remdesivir in clinical trials as a
potential treatment for COVID-19. Ligand continues to meet Captisol
requirements to support remdesivir clinical trials and
manufacturing scale-up. Our partner Gilead Sciences announced that
it has accelerated manufacturing timelines to increase the supply
of the drug before knowing whether remdesivir is safe and effective
in patients with COVID-19. Multiple clinical trials for remdesivir
are underway, involving thousands of patients with COVID-19 across
the world. Public information indicates initial clinical trial data
will be available over the next several weeks.
Ligand’s Captisol technology has applicability in a broad array
of therapeutic indications. Captisol is used in approved treatments
such as Amgen’s Kyprolis and Acrotech/CASI’s Evomela to treat
patients with multiple myeloma, a life-threatening cancer, and is
utilized in Sage Therapeutics’ Zulresso, which was recently
approved by the FDA for mothers suffering from post-partum
depression.
Ligand’s Captisol network is served by manufacturing plants in
two European countries and five distribution facilities around the
globe, all of which remain fully operational. Ligand has
substantial capacity to supply Captisol manufactured according to
cGMP and our focus is to ensure sufficient supply to meet all
existing and future partner needs, and to supply Gilead should
remdesivir be demonstrated to be safe and effective to treat
COVID-19. Ligand is also evaluating plans with its supply partner
to further increase capacity by bringing additional sites online if
needed.
Vernalis Business Update
Ligand recently entered into an exclusive worldwide license
agreement with Neuritek Therapeutics to develop and commercialize
V158866, a novel, oral, selective fatty acid amide hydrolase (FAAH)
inhibitor that was discovered using the Vernalis Design Platform
(VDP). Neuritek plans to develop V158866 for post-traumatic stress
disorder and other CNS diseases. Under the terms of the agreement,
Ligand will receive an upfront license fee and is eligible to
receive a financing-related milestone, development and
commercialization milestones and tiered royalties on net sales in
the mid-to-high single digits. On March 31, 2020, Neuritek
announced it had secured approximately $27 million in a capital
commitment from the GEM group, GEM Global Yield LLC SCS.
Recent third-party academic drug analyses suggest a potential
role for heat shock protein 90 (Hsp90) inhibitors in treating
COVID-19 infection. Based on these studies, we are evaluating
potential collaborations or partnerships relating to intravenous
luminespib (AUY-922) as a potential treatment for patients with
COVID-19. Luminespib is a Phase 2-ready Hsp90 inhibitor, previously
investigated in clinical trials for cancer.
Acquisition Update
On April 1, 2020 Ligand closed its acquisition of the core
assets of Icagen’s North Carolina operations, including two
significant partnered programs, proprietary ion channel screening
and assay platforms, x-ray fluorescence capabilities, custom
screening technologies and six preclinical-stage internal programs
applicable to a range of indications including diabetes,
Parkinson’s disease, pain and others. The two partnered programs
are a collaboration with Roche to develop and commercialize
therapies for neurological diseases, which includes research
funding, up to $274 million in potential milestone payments and
tiered royalties on net sales, and a collaboration with the Cystic
Fibrosis Foundation (CFF) Collaboration to discover therapeutics to
treat patients with cystic fibrosis caused by specific genetic
mutations. The CFF collaboration allows for up to $11 million in
research funding, up to $59 million in milestone payments and
tiered royalties on net sales.
Capital Deployment and Strategy Update
Ligand estimates that, as of March 31, 2020, its cash and cash
equivalents were approximately $735 million and outstanding
convertible debt was approximately $516 million. First quarter
estimated cash and cash equivalents is lower compared to the end of
2019, primarily because over the past several weeks Ligand
repurchased $234 million in principal amount of its convertibles
notes at a price of $203 million, and repurchased 473,000 common
shares for $37 million. These estimated amounts are preliminary and
are subject to completion of financial and quarterly closing
procedures.
We have a successful track record of acquiring innovative
companies and subsequently growing revenue, increasing our
partnered portfolio, and leveraging technology and customer
synergies. Given our significant financial resources and talented
operating team, we believe we are well positioned to pursue
acquisitions and new opportunities to expand our business.
First Quarter 2020 Earnings Conference Call
Ligand announced plans to report first quarter 2020 financial
results and hold an earnings conference call on May 6, 2020 after
market close. Details about the conference call will be announced
approximately two weeks in advance.
About Ligand Pharmaceuticals
Ligand is a biopharmaceutical company focused on developing or
acquiring technologies that help pharmaceutical companies discover
and develop medicines. Our business model creates value for
stockholders by providing a diversified portfolio of biotech and
pharmaceutical product revenue streams that are supported by an
efficient and low corporate cost structure. Our goal is to offer
investors an opportunity to participate in the promise of the
biotech industry in a profitable, diversified and lower-risk
business than a typical biotech company. Our business model is
based on doing what we do best: drug discovery, early-stage drug
development, product reformulation and partnering. We partner with
other pharmaceutical companies to leverage what they do best
(late-stage development, regulatory management and
commercialization) to ultimately generate our revenue. Ligand’s
OmniAb technology platform is a patent-protected transgenic animal
platform used in the discovery of fully human mono- and bispecific
therapeutic antibodies. The Captisol platform technology is a
patent-protected, chemically modified cyclodextrin with a structure
designed to optimize the solubility and stability of drugs. The
Vernalis Design Platform (VDP) integrates protein structure
determination and engineering, fragment screening and molecular
modeling, with medicinal chemistry, to help enable success in novel
drug discovery programs against highly-challenging targets. Ab
Initio™ technology and services for the design and preparation of
customized antigens enable the successful discovery of therapeutic
antibodies against difficult-to-access cellular targets. Ligand has
established multiple alliances, licenses and other business
relationships with the world’s leading pharmaceutical companies
including Amgen, Merck, Pfizer, Sanofi, Janssen, Takeda, Gilead
Sciences and Baxter International. For more information, please
visit www.ligand.com.
Forward-Looking Statements
This news release contains forward-looking statements by Ligand
that involve risks and uncertainties and reflect Ligand’s judgment
as of the date of this release. These include statements regarding:
Ligand’s estimated cash and debt amounts as of March 31, 2020; the
timeline for manufacturing remdesivir and timing of initial data
from ongoing clinical trials of remdesivir to treat patients with
COVID-19; the expected use of proceeds from Pandion’s financing;
Ligand’s expectation that it will have sufficient supply of
Captisol to meet all existing and future partner needs; Ligand’s
plans to pursue collaborations relating to intravenous Luminespib
(AUY-922) as a potential treatment for patients with COVID-19; and
anticipated benefits of the Neuritek license agreement and Icagen
asset acquisition. Actual events or results may differ from
Ligand's expectations due to risks and uncertainties inherent in
Ligand’s business, including, without limitation; Ligand’s partners
may not order as much Captisol as Ligand expects; remdesivir is not
yet licensed or approved anywhere globally and has not been
demonstrated to be safe or effective for any use, including
treatment of COVID-19; Ligand may not be able to provide sufficient
supply of Captisol to meet all existing and future partner needs,
including Gilead; the recent outbreak of the COVID-19 coronavirus
may disrupt Ligand's and its partners' business, including delaying
manufacturing, preclinical studies and clinical trials and product
sales, and impairing global economic activity, all of which could
materially and adversely affect our results of operations and
financial condition; Ligand may not receive expected revenue from
royalties, Captisol material sales and license fees and milestone
revenue; results of any clinical study may not be timely, favorable
or confirmed by later studies; products under development by Ligand
or its partners may not receive regulatory approval; there may not
be a market for the product(s) even if successfully developed and
approved; Ligand and its partners may experience delays in the
commencement, enrollment, completion or analysis of clinical
testing for its product candidates, or significant issues regarding
the adequacy of its clinical trial designs or the execution of its
clinical trials, which could result in increased costs and delays,
or limit Ligand's ability to obtain regulatory approval; Ligand may
not be able to successfully implement its strategic growth plan and
continue the development of its proprietary programs; Ligand may
not be successful in securing collaborations for Luminespib;
estimated cash and debt amounts may change following completion of
its financial statements and quarterly review, such estimated
amounts do not present all information necessary for an
understanding of Ligand’s financial condition as of March 31, 2020;
and the anticipated benefits of the Neuritek license agreement or
Icagen acquisition may not be realized or may be affected by
competition or other external events. The failure to meet
expectations with respect to any of the foregoing matters may
reduce Ligand’s stock price. Additional information concerning
these and other important risk factors affecting Ligand can be
found in Ligand’s prior press releases available at www.ligand.com
as well as in Ligand’s public periodic filings with the Securities
and Exchange Commission, available at www.sec.gov. Ligand disclaims
any intent or obligation to update these forward-looking statements
beyond the date of this press release, except as required by law.
This caution is made under the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995.
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version on businesswire.com: https://www.businesswire.com/news/home/20200406005284/en/
Ligand Pharmaceuticals Incorporated Patrick O’Brien
investors@ligand.com (858) 550-7768 @Ligand_LGND
LHA Investor Relations Bruce Voss bvoss@lhai.com (310)
691-7100
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