Assertio Holdings, Inc. (Nasdaq: ASRT) (“Assertio”), a specialty
pharmaceutical company offering differentiated products to
patients, and Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI)
(“Spectrum”), a commercial stage biopharmaceutical company focused
on novel and targeted oncology, today announced that they have
entered into a definitive agreement pursuant to which Assertio will
acquire all outstanding shares of Spectrum in an all-stock and
contingent value rights (“CVR”) transaction.
“The addition of Spectrum’s commercial
capabilities and ROLVEDON, a novel long-acting G-CSF product
recently launched into a blockbuster market in October 2022,
exemplifies Assertio’s attractiveness as an acquirer of new,
accretive assets across diverse therapeutic categories, and ability
to continue their growth and achieve profitable contributions
faster and more efficiently than could be achieved on a standalone
basis. We intend to retain the majority of Spectrum’s commercial
infrastructure, which we believe is synergistic to our digital
non-personal platform, deploying these complementary dual channels
to support clinical messaging, reimbursement education and ROLVEDON
awareness to further aid and accelerate its launch,” said Dan
Peisert, President and Chief Executive Officer of Assertio.
“We are excited to combine with Assertio in a
transaction that will deliver significant value to our stockholders
and the opportunity to share in the future upside of ROLVEDON,”
said Tom Riga, President and Chief Executive Officer of Spectrum
Pharmaceuticals. “Our mission at Spectrum has always been to make a
difference in the lives of patients and with Assertio, we have a
partner that will enable us to deliver on this promise. Our
combined assets and commercial infrastructure will position us to
accelerate ROLVEDON’s launch for the benefit of patients, maximize
its potential and drive further growth. We are proud of the launch
trajectory our team has achieved with ROLVEDON and look forward to
an exciting new chapter.”
Terms of the Agreement
Under the terms of the agreement, at closing,
Spectrum stockholders will receive a fixed exchange ratio of 0.1783
shares of Assertio common stock for each share of Spectrum common
stock they own, implying an upfront value of $1.14 per Spectrum
share (approximately $248 million) based on Assertio’s stock price
on April 24, 2023 and an initial 65% premium to Spectrum’s closing
price on such date. Additionally, Spectrum stockholders will
receive one CVR per Spectrum share entitling them to receive up to
an additional $0.20 per share in total (approximately $43 million),
payable in cash or stock at Assertio's election, for $1.34
(approximately $291 million), a total potential premium of 94%.
Subject to adjustments, each CVR shall represent the right to
receive $0.10 payable upon ROLVEDON net sales (less certain
deductions) achieving $175 million during the calendar year ending
December 31, 2024, and $0.10 payable upon ROLVEDON net sales (less
certain deductions) achieving $225 million during the calendar year
ending December 31, 2025.
Following the close of the transaction, Assertio
stockholders will own approximately 65% of the combined company,
and Spectrum stockholders will own approximately 35%, on a fully
diluted basis.
Transaction Strategic and Financial
Rationale
Strengthened Commercial Infrastructure
and Resources: Assertio’s innovative digital non-personal
sales model complements Spectrum’s in-person commercial
infrastructure, providing greater market access and resources than
either company as a standalone entity.
Expected to Be Accretive to Adjusted EPS
and Operating Cash Flow in 2024: Assertio intends to
retain the majority of Spectrum’s commercial team and add operating
costs of approximately $60 million annually. The remaining cost
synergies are expected to accelerate and enhance the profit
opportunities for the combined company and generate double-digit
accretion to adjusted EPS and increased operating cash flow in
2024.
Enhanced IP Portfolio:
ROLVEDON’s intellectual property protection is anticipated to
extend through 2036, complementing Assertio’s portfolio of
traditional and non-traditional IP protection, including assets
with protection extending beyond 2040 and plans to secure
additional protections on existing assets.
Improved Strategic Profile: The
transaction enables the combined company to have a more scalable
and competitive infrastructure for continuing the development and
acquisition of existing and prospective new commercial- and late
development-stage products suited to Assertio’s unique omni-channel
sales strategy.
Platform Diversification: In
addition to Assertio’s key assets Indocin, Sympazan and Otrexup,
Spectrum’s key asset ROLVEDON will represent meaningful further
asset diversification. ROLVEDON is a long-acting growth factor
(G-CSF) indicated to decrease the incidence of infection, as
manifested by febrile neutropenia, in adult patients with
non-myeloid malignancies receiving myelosuppressive anti-cancer
drugs associated with clinically significant incidence of febrile
neutropenia.
Access to Capital Markets: With
enhanced scale and greater diversification of revenue generating
commercial assets, the combined company is expected to have a more
attractive profile to investors and to benefit from greater access
to the capital markets.
Approvals and Timing to
Close
The transaction, which has been approved by the
boards of directors of both companies, is expected to close in the
third quarter of 2023, subject to approval by Assertio and Spectrum
stockholders and the satisfaction of customary closing
conditions.
Conference Call and Investor
Presentation Information
Assertio and Spectrum will host a conference
call today, at 8:30 am Eastern Time to discuss the transaction.
Date: |
April 25, 2023 |
Time: |
8:30 a.m. Eastern Time |
Webcast (live and archive) and Presentation: |
http://investor.assertiotx.com/overview/default.aspxhttps://investor.sppirx.com/events-and-presentations |
Dial-in numbers: |
1-929-201-5912 |
Conference number: |
9687947 |
Please connect at least 15 minutes prior to the
live webcast to ensure adequate time for any software download that
may be needed to access the webcast. The replay will be available
approximately two hours after the call on the investor
websites.
Advisors
Guggenheim Securities, LLC is acting as
financial advisor to Spectrum, and Gibson, Dunn & Crutcher LLP
is serving as legal counsel.
SVB Securities and H.C. Wainwright & Co. are
acting as financial advisors to Assertio, and Latham & Watkins
LLP is serving as legal counsel.
About Assertio
Assertio is a specialty pharmaceutical company
offering differentiated products to patients utilizing a
non-personal promotional model. We have built and continue to build
our commercial portfolio by identifying new opportunities within
our existing products as well as acquisitions or licensing of
additional approved products. To learn more about Assertio, visit
www.assertiotx.com.
About Spectrum
Spectrum is a commercial stage biopharmaceutical
company, with a strategy of acquiring, developing, and
commercializing novel and targeted oncology therapies. We have an
in-house clinical development organization with regulatory and data
management capabilities, in addition to commercial infrastructure
and a field based sales force for our marketed product, ROLVEDON™
(eflapegrastim-xnst) Injection. For additional information on
Spectrum please visit www.sppirx.com.
Forward-Looking Statements
The statements in this communication include
forward-looking statements concerning Assertio and Spectrum, the
proposed transactions and other related matters. Forward-looking
statements may discuss goals, intentions and expectations as to
future plans, trends, events, results of operations or financial
condition, or otherwise, based on current beliefs and involve
numerous risks and uncertainties that could cause actual results to
differ materially from expectations. Forward-looking statements
speak only as of the date they are made or as of the dates
indicated in the statements and should not be relied upon as
predictions of future events, as there can be no assurance that the
events or circumstances reflected in these statements will be
achieved or will occur. Forward-looking statements can often, but
not always, be identified by the use of forward-looking terminology
including “believes,” “expects,” “may,” “will,” “should,” “seeks,”
“intends,” “plans,” “pro forma,” “estimates,” “anticipates,”
“designed,” or the negative of these words and phrases, other
variations of these words and phrases or comparable terminology.
These forward-looking statements involve risks and uncertainties
that could cause actual results to differ materially from those
contemplated by the statements, including: failure to obtain
applicable regulatory or stockholder approvals in a timely manner
or otherwise; failure to satisfy other closing conditions to the
proposed transactions; risks that the new businesses will not be
integrated successfully or that the combined company will not
realize estimated cost savings, value of certain tax assets,
synergies and growth, or that such benefits may take longer to
realize than expected; failure to realize anticipated benefits of
the combined operations; risks relating to unanticipated costs of
integration; demand for the combined company’s products; the
growth, change and competitive landscape of the markets in which
the combined company participates; expected industry trends,
including pricing pressures and managed healthcare practices;
variations in revenues obtained from commercialization agreements,
including contingent milestone payments, royalties, license fees
and other contract revenues, including non-recurring revenues, and
the accounting treatment with respect thereto; Assertio’s and
Spectrum’s abilities to obtain and maintain intellectual property
protection for their respective products and operate their
respective businesses without infringing the intellectual property
rights of others; the commercial success and market acceptance of
Assertio’s and Spectrum’s products; the entry and sales of generics
of Assertio’s products including the Indocin products which are not
patent protected and may face generic competition at any time; the
outcome of, and Assertio’s intentions with respect to, any
litigation or investigations, including antitrust litigation,
opioid-related investigations, opioid-related litigation and
related claims for negligence and breach of fiduciary duty against
Assertio’s former insurance broker, and other disputes and
litigation, and the costs and expenses associated therewith; and
the ability of Assertio’s and Spectrum’s third-party manufacturers
to manufacture adequate quantities of commercially salable
inventory and active pharmaceutical ingredients for each of their
respective products, and Assertio’s and Spectrum’s abilities to
maintain their respective supply chains. For a discussion of
additional factors that could cause actual results to differ
materially from those contemplated by forward-looking statements,
see the sections captioned “Risk Factors” in Assertio’s and
Spectrum’s Annual Reports on Form 10-K for the year ended December
31, 2022 and other filings with the Securities and Exchange
Commission (the “SEC”). Many of these risks and uncertainties may
be exacerbated by the COVID-19 pandemic and any worsening of the
global business and economic environment as a result. Assertio and
Spectrum do not assume, and hereby disclaim, any obligation to
update forward-looking statements, except as may be required by
law.
About ROLVEDON™
ROLVEDON™ (eflapegrastim-xnst) injection is a
long-acting granulocyte colony-stimulating factor (G-CSF) with a
novel formulation. Spectrum has received an indication to decrease
the incidence of infection, as manifested by febrile neutropenia,
in adult patients with non-myeloid malignancies receiving
myelosuppressive anti-cancer drugs associated with clinically
significant incidence of febrile neutropenia. ROLVEDON is not
indicated for the mobilization of peripheral blood progenitor cells
for hematopoietic stem cell transplantation. The BLA for ROLVEDON
was supported by data from two identically designed Phase 3,
randomized, open-label, noninferiority clinical trials, ADVANCE and
RECOVER, which evaluated the safety and efficacy of ROLVEDON in 643
early-stage breast cancer patients for the management of
neutropenia due to myelosuppressive chemotherapy. In both studies,
ROLVEDON demonstrated the pre-specified hypothesis of
non-inferiority (NI) in mean duration of severe neutropenia (DSN)
and a similar safety profile to pegfilgrastim. ROLVEDON also
demonstrated non-inferiority to pegfilgrastim in the mean DSN
across all four cycles (all NI p<0.0001) in both trials.
Please see the Important Safety Information
below and the full prescribing information for ROLVEDON at
www.rolvedon.com.
Indications and UsageROLVEDON
is indicated to decrease the incidence of infection, as manifested
by febrile neutropenia, in adult patients with non-myeloid
malignancies receiving myelosuppressive anti-cancer drugs
associated with clinically significant incidence of febrile
neutropenia.
Limitations of UseROLVEDON is not indicated for
the mobilization of peripheral blood progenitor cells for
hematopoietic stem cell transplantation.
Important Safety
InformationContraindications
- ROLVEDON is contraindicated in
patients with a history of serious allergic reactions to
eflapegrastim, pegfilgrastim or filgrastim products. Reactions may
include anaphylaxis.
Warnings and
PrecautionsSplenic Rupture
- Splenic rupture, including fatal
cases, can occur following the administration of recombinant human
granulocyte colony-stimulating factor (rhG-CSF) products. Evaluate
patients who report left upper abdominal or shoulder pain for an
enlarged spleen or splenic rupture.
Acute Respiratory Distress Syndrome
(ARDS)
- ARDS can occur in patients
receiving rhG-CSF products. Evaluate patients who develop fever,
lung infiltrates, or respiratory distress. Discontinue ROLVEDON in
patients with ARDS.
Serious Allergic Reactions
- Serious allergic reactions,
including anaphylaxis, can occur in patients receiving rhG-CSF
products. Permanently discontinue ROLVEDON in patients who
experience serious allergic reactions.
Sickle Cell Crisis in Patients with
Sickle Cell Disorders
- Severe and sometimes fatal sickle
cell crises can occur in patients with sickle cell disorders
receiving rhG-CSF products. Discontinue ROLVEDON if sickle cell
crisis occurs.
Glomerulonephritis
- Glomerulonephritis has occurred in
patients receiving rhG-CSF products. The diagnoses were based upon
azotemia, hematuria (microscopic and macroscopic), proteinuria, and
renal biopsy. Generally, events of glomerulonephritis resolved
after dose-reduction or discontinuation. Evaluate and consider dose
reduction or interruption of ROLVEDON if causality is likely.
Leukocytosis
- White blood cell (WBC) counts of
100 x 109/L or greater have been observed in patients receiving
rhG-CSF products. Monitor complete blood count (CBC) during
ROLVEDON therapy. Discontinue ROLVEDON treatment if WBC count of
100 x 109/L or greater occurs.
Thrombocytopenia
- Thrombocytopenia has been reported
in patients receiving rhG-CSF products. Monitor platelet
counts.
Capillary Leak Syndrome
- Capillary leak syndrome has been
reported after administration of rhG-CSF products and is
characterized by hypotension, hypoalbuminemia, edema and
hemoconcentration. Episodes vary in frequency and severity and may
be life-threatening if treatment is delayed. If symptoms develop,
closely monitor and give standard symptomatic treatment, which may
include a need for intensive care.
Potential for Tumor Growth Stimulatory
Effects on Malignant Cells
- The granulocyte colony-stimulating
factor (G-CSF) receptor through which ROLVEDON acts has been found
on tumor cell lines. The possibility that ROLVEDON acts as a growth
factor for any tumor type, including myeloid malignancies and
myelodysplasia, diseases for which ROLVEDON is not approved, cannot
be excluded.
Myelodysplastic Syndrome (MDS) and Acute
Myeloid Leukemia (AML) in Patients with Breast and Lung
Cancer
- MDS and AML have been associated
with the use of rhG-CSF products in conjunction with chemotherapy
and/or radiotherapy in patients with breast and lung cancer.
Monitor patients for signs and symptoms of MDS/AML in these
settings.
Aortitis
- Aortitis has been reported in
patients receiving rhG-CSF products. It may occur as early as the
first week after start of therapy. Consider aortitis in patients
who develop generalized signs and symptoms such as fever, abdominal
pain, malaise, back pain, and increased inflammatory markers (e.g.,
c-reactive protein and white blood cell count) without known
etiology. Discontinue ROLVEDON if aortitis is suspected.
Nuclear Imaging
- Increased hematopoietic activity of
the bone marrow in response to growth factor therapy has been
associated with transient positive bone imaging changes. This
should be considered when interpreting bone imaging results.
Adverse Reactions
- The most common adverse reactions
(≥20%) were fatigue, nausea, diarrhea, bone pain, headache,
pyrexia, anemia, rash, myalgia, arthralgia, and back pain.
- Permanent discontinuation due to an
adverse reaction occurred in 4% of patients who received ROLVEDON.
The adverse reaction requiring permanent discontinuation in 3
patients who received ROLVEDON was rash.
To report SUSPECTED ADVERSE REACTIONS,
contact Spectrum Pharmaceuticals, Inc. at 1-888-713-0688 or FDA at
1800FDA1088 or www.fda.gov/medwatch
SPECTRUM PHARMACEUTICALS, INC.® is a registered
trademark of Spectrum Pharmaceuticals, Inc. and its
affiliates. REDEFINING CANCER CARE™ and ROLVEDON™ are the Spectrum
Pharmaceuticals’ logos and trademarks owned by Spectrum
Pharmaceuticals, Inc. Any other trademarks are the property of
their respective owners.
No Offer or Solicitation
This communication is not intended to and does
not constitute an offer to sell or the solicitation of an offer to
subscribe for or buy or an invitation to purchase or subscribe for
any securities or the solicitation of any vote in any jurisdiction
pursuant to the proposed transactions or otherwise, nor shall there
be any sale, issuance or transfer of securities in any jurisdiction
in contravention of applicable law. No offer of securities shall be
made except by means of a prospectus meeting the requirements of
Section 10 of the Securities Act of 1933, as amended. Subject to
certain exceptions to be approved by the relevant regulators or
certain facts to be ascertained, the public offer will not be made
directly or indirectly, in or into any jurisdiction where to do so
would constitute a violation of the laws of such jurisdiction, or
by use of the mails or by any means or instrumentality (including
without limitation, facsimile transmission, telephone and the
internet) of interstate or foreign commerce, or any facility of a
national securities exchange, of any such jurisdiction.
Important Additional Information Will be
Filed with the SEC
Assertio will file with the SEC a Registration
Statement on Form S-4, which will include a joint proxy statement
and prospectus of both Assertio and Spectrum (the “joint proxy
statement/prospectus”). INVESTORS AND STOCKHOLDERS ARE
URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS, AND OTHER
RELEVANT DOCUMENTS TO BE FILED WITH THE SEC, IN THEIR ENTIRETY
CAREFULLY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN
IMPORTANT INFORMATION ABOUT ASSERTIO, SPECTRUM, THE PROPOSED
TRANSACTIONS AND RELATED MATTERS. Investors and
stockholders will be able to obtain free copies of the joint proxy
statement/prospectus and other documents filed with the SEC by
Assertio and Spectrum through the website maintained by the SEC at
www.sec.gov. In addition, investors and stockholders will be able
to obtain free copies of the joint proxy statement/prospectus and
other documents filed with the SEC by Assertio and Spectrum by
contacting Investor Relations at Assertio Holdings, Inc., 100 South
Sanders Rd., Suite 300, Lake Forest, IL 60045 (for documents filed
by Assertio) or Investor Relations at Spectrum Pharmaceuticals,
Inc. by email at ir@sppirx.com or by phone at (949) 788-6700 (for
documents filed by Spectrum).
Participants in the
Solicitation
Assertio and Spectrum and their respective
directors and executive officers may be deemed to be participants
in the solicitation of proxies from their respective stockholders
in respect of the proposed transactions contemplated by the joint
proxy statement/prospectus. Information regarding the persons who
are, under the rules of the SEC, participants in the solicitation
of the stockholders of Assertio and Spectrum in connection with the
proposed transactions, including a description of their direct or
indirect interests, by security holdings or otherwise, will be set
forth in the joint proxy statement/prospectus when it is filed with
the SEC. Information regarding Assertio’s directors and executive
officers is contained in its Annual Report on Form 10-K for the
year ended December 31, 2022 and its Proxy Statement on Schedule
14A, dated April 3, 2023, which are filed with the SEC. Information
regarding Spectrum’s directors and executive officers is contained
in its Annual Report on Form 10-K for the year ended December 31,
2022 and its Proxy Statement on Schedule 14A, dated April 27, 2022,
which are filed with the SEC.
Assertio Investor Contact Matt KrepsDarrow
AssociatesM: 214-597-8200mkreps@darrowir.com
Spectrum Investor ContactsNora Brennan Chief
Financial Officer/Investor Relations
949-788-6700InvestorRelations@sppirx.com
Lisa WilsonIn-Site Communications,
Inc.212-452-2793lwilson@insitecony.com
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