SAN FRANCISCO and BOULDER, Colo., June
22, 2020 /PRNewswire/ -- Invitae (NYSE: NVTA), a
leading genetics company, and ArcherDX, a leading genomics
analysis company democratizing precision oncology, today announced
the companies have entered into a definitive agreement under which
Invitae will combine with ArcherDX to create a genetics leader
with unrivaled breadth and scale in cancer genetics and precision
oncology.
The combined company will be poised to transform care for cancer
patients, accelerating adoption of genetics through the most
comprehensive suite of products and services available. Integrating
germline testing, tumor profiling and liquid biopsy technologies
and services in a single platform will enable precision approaches
from diagnostic testing to therapy optimization and monitoring,
expanding access to best-in-class personalized oncology.
"From the beginning, Invitae's goal has been to aggregate the
world's genetic tests into a single platform in service of our
mission to bring comprehensive genetic information into mainstream
medicine. Today, we take another major step forward in that
effort," said Sean George, Ph.D.,
co-founder and chief executive officer of Invitae.
"ArcherDX and Invitae share a foundational belief in the
power of genomic information to impact care. We are thrilled
to unite with Invitae to form the leading hub for precision
oncology, diagnostics, therapy optimization and monitoring, with an
opportunity to accelerate both patient care and shareholder value,"
said Jason Myers, Ph.D., chief
executive officer and co-founder of ArcherDX. "ArcherDX was
founded to democratize precision oncology with best-in-class
products that are personal, actionable and available in local care
settings. We see STRATAFIDE DX™ as a significant
near-term value driver, currently under development for cancer
therapy optimization, while PCM™ provides an exciting opportunity
to transform cancer care through multiple monitoring applications.
ArcherDX products, workflow and powerful bioinformatics
solutions provide an opportunity to advance precision oncology into
regional and community settings and address an estimated
$45 billion market opportunity.
Together with Invitae, we look forward to expanding our impact
beyond oncology, driving significant value through shared expertise
to inform healthcare throughout life, globally."
"Integrating all aspects of cancer genetics can transform care
for patients and the flexibility that comes from both centralized
and decentralized capabilities will uniquely position Invitae to
meet the needs of customers worldwide," continued Dr. George. "By
joining together, we will unite world-class capabilities in the
hands of a talented team with complementary expertise and strong
brands in service of a shared goal to improve healthcare for
patients."
Accelerating access and adoption of genetics to improve
cancer care
Broad adoption of precision oncology has been limited,
particularly in regional and community settings where approximately
85 percent of patients receive care.1 Without
precision oncology, late-stage cancer patients can suffer from poor
prognosis and outcomes, while early-stage patients may receive an
inaccurate prognosis that results in unnecessary treatment and
delayed detection of
recurrence.2,3
Uniting Invitae and ArcherDX will offer comprehensive
support for precision oncology.
- Invitae has quickly become a leader in diagnostic and
hereditary risk testing and has strong relationships with
clinicians caring for cancer patients, including cancer genetic
counselors, oncologists and imaging centers.
- ArcherDX's platform, with its proprietary Anchored
Multiplex PCR (AMP™) chemistry at the core, has enabled it to
develop industry-leading products and services under investigation
to optimize therapy and enable cancer monitoring across liquid and
tissue samples.
- ArcherDX has developed and commercialized over 325 unique
products, including research products and services in use by more
than 300 laboratories worldwide and has collaborated with more than
50 biopharmaceutical companies and contract research organizations
(CROs), providing services that enable biopharmaceutical companies,
including partners such as AstraZeneca, BMS and Bayer, to
cost-effectively accelerate drug development.
- ArcherDX is also currently developing in-vitro diagnostic
(IVD) products, including STRATAFIDE DX, for therapy
optimization, an estimated $5 billion
market opportunity with U.S. Food and Drug Administration (FDA)
submissions planned this year, and the broadly applicable
Personalized Cancer Monitoring (PCM) in development for disease
recurrence monitoring, therapy optimization including selection,
response and modulation. Both STRATAFIDE DX and PCM have
received Breakthrough Device designation from the FDA.
- Together, the company will be ideally positioned to serve
customers across the continuum, from individuals and community
clinicians to biopharmaceutical partners, distribution partners,
reference laboratories and academic centers. Invitae's central
laboratory provides support for customers who prefer to send out
and can benefit from a full suite of services including reporting,
clinician consultation and genetic counseling for patients, while
ArcherDX's decentralized model supports geographies and customers
where local control of patient reporting is either desired or
required.
With both centralized and local testing capabilities, the
combined organization will offer breadth and flexibility in serving
customers in more than 95 markets. Together, Invitae and
ArcherDX will offer robust support for biopharmaceutical
companies, from patient identification and screening, to biomarker
identification and companion diagnostic development.
Transaction Terms
Under the terms of the agreement, Invitae will acquire
ArcherDX for upfront consideration consisting of 30 million
shares of Invitae common stock and $325
million in cash, plus up to an additional 27 million shares
of Invitae common stock payable in connection with the achievement
of certain milestones, for an overall transaction valued at
approximately $1.4 billion. The
transaction, which has been unanimously approved by the Boards of
Directors of both companies, is expected to close in several
months, subject to customary closing conditions including approval
by the stockholders of Invitae and ArcherDX.
Financing Activities
In connection with the proposed combination, Invitae has
arranged a strategic financing with over $400 million in financing commitments from a
premier syndicate of life sciences investors, led by Perceptive
Advisors. Invitae has entered into a definitive agreement to sell
$275 million in common stock in a
private placement at a price of $16.85 per share. The private placement is being
supported by key existing investors in Invitae and Archer,
including Casdin Capital, Deerfield Management, Driehaus Capital
Management, Farallon, PBM Capital, Perceptive Advisors, Redmile
Group, Rock Springs Capital, Soleus Capital, and one additional
institutional investor. The placement is expected to close
concurrently with the proposed combination, subject to the
satisfaction of customary closing conditions. Invitae has also
entered into a fully committed credit facility for up to
$200 million with Perceptive Credit
Opportunities Funds, subject to certain customary closing
conditions.
Since the filing of its Quarterly Report on Form 10-Q for the
quarter ended March 31, 2020, Invitae
has sold under its ATM facility approximately 2.6 million shares of
common stock for aggregate gross proceeds of $46 million at an average price of $17.59 per share.
Invitae's current expectations regarding its cash at transaction
close would be approximately $425
million and its annualized near-term forward cash burn is
expected to be approximately $130
million.
Advisors
Perella Weinberg Partners served as lead financial advisor to
Invitae in connection with the business combination and Cowen
served as co-financial advisor. Cowen served as lead-placement
agent to Invitae for the private placement and Perella Weinberg
Partners served as co-placement agent; Cowen served as exclusive
financial advisor to Invitae in connection with the senior secured
term loan facility. Evercore and J.P. Morgan Securities LLC acted
as financial advisors to Archer.
Webcast
Management will host a conference call and webcast today at
5:00 a.m. PT / 6:00 a.m. MT / 8:00 a.m.
ET to discuss the transaction. The dial-in numbers for the
conference call are (866) 324-3683 for domestic callers and (509)
844-0959 for international callers, and the reservation number for
both is 7097864. Please note, after dialing in, you will be
prompted to enter the Conference ID and then the pound "#" sign to
enter the call. Following prepared remarks, management will respond
to questions from analysts, subject to time limitations.
The live webcast of the call and slide deck may be accessed by
visiting the investors section of the company's website
at ir.invitae.com. A replay of the webcast and conference
call will be available shortly after the conclusion of the call and
will be archived on the company's website.
About Invitae
Invitae Corporation (NYSE: NVTA) is a leading medical
genetics company, whose mission is to bring comprehensive genetic
information into mainstream medicine to improve healthcare for
billions of people. Invitae's goal is to aggregate the world's
genetic tests into a single service with higher quality, faster
turnaround time, and lower prices. For more information, visit the
company's website at invitae.com.
About ArcherDX
ArcherDX is a leading genomic analysis company democratizing
precision oncology through a suite of products and services that
are highly accurate, personal, actionable and easy to use in local
settings. Our ArcherDX® platform, with our
proprietary Anchored Multiplex PCR (AMP™) chemistry at the core,
has enabled us to develop industry-leading products and services
with the goal to optimize therapy and enable cancer monitoring
across sample types. We develop and commercialize research
products, are developing in vitro diagnostic (IVD) products, and
offer services that meet the unique needs of our customers and
their clinical applications. Our research product portfolio
consists of VariantPlex®, FusionPlex®,
LiquidPlex™ and Immunoverse™, which we collectively refer to as
ArcherPlex™. IVD products currently in development for solid tumor
biomarker identification and Personalized Cancer Monitoring (PCM)
have both received Breakthrough Device Designation from the FDA.
ArcherDX is headquartered in Boulder, Colorado. Learn more at
www.archerdx.com and follow @ArcherDXInc on Twitter,
Facebook and LinkedIn.
Safe Harbor Statement
This press release contains statements, including statements
regarding the proposed acquisition of ArcherDX, Inc. ("Archer") by
Invitae Corporation ("Invitae") that are forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended, that are intended to be covered by the "safe harbor"
created by those sections. Forward-looking statements, which are
based on certain assumptions and describe future plans, strategies,
expectations and events, can generally be identified by the use of
forward-looking terms such as "believe," "expect," "may," "will,"
"should," "would," "could," "seek," "intend," "plan," "goal,"
"project," "estimate," "anticipate" or other comparable terms. All
statements other than statements of historical facts included in
this presentation regarding strategies, synergies, prospects,
financial results, operations, costs, plans, objectives, and the
proposed acquisition of Archer by Invitae are forward-looking
statements. Forward-looking statements include, but are not limited
to, statements regarding expected future operating results,
including cash at closing and annualized forward cash burn, drivers
of future value, future products and services and customers served,
regulatory submissions, anticipated results of product development
efforts, potential addressable markets, the impact of Covid-19, the
anticipated benefits of the proposed acquisition of Archer,
including expected synergies, opportunities, product offerings, and
financial and other impacts, the transaction structure and
financing plans, and the expected timing of completion of the
proposed transaction. Forward-looking statements are neither
historical facts nor assurances of future performance or events.
Instead, they are based only on current beliefs, expectations and
assumptions regarding future business developments, future plans
and strategies, projections, anticipated events and trends, the
economy and other future conditions. Forward-looking statements are
subject to inherent uncertainties, risks and changes in
circumstances that are difficult to predict and many of which are
outside of our control. Actual results, conditions and events may
differ materially from those indicated in the forward-looking
statements. Therefore, you should not rely on any of these
forward-looking statements. Important factors that could cause
actual results, conditions and events to differ materially from
those indicated in the forward-looking statements include, but are
not limited to: the ability to successfully and profitably market
our products and services; the acceptance of our products and
services by patients and healthcare providers; the ability to meet
demand for our products and services; the availability and
sufficiency of reimbursement; the amount and nature of competition;
the effects of the adoption, modification or repeal of any law,
rule, order, interpretation or policy relating to the healthcare
system, including without limitation as a result of any judicial,
executive or legislative action; the impact of Covid-19 on the
business of Invitae and Archer; Invitae's ability to manage its
growth effectively; the ability of Invitae and Archer to
successfully develop new products and services; the ability to
effectively utilize strategic partnerships and acquisitions; the
ability of Invitae and Archer to obtain and maintain regulatory
approvals and comply with applicable regulations; the ability of
Invitae and Archer to obtain the required regulatory approvals for
the proposed merger and the approval of Invitae's and Archer's
stockholders, and to satisfy the other conditions to the closing of
the acquisition and related financing transactions on a timely
basis or at all; the occurrence of events that may give rise to a
right of one or both of Invitae and Archer to terminate the merger
agreement; negative effects of the announcement or the consummation
of the acquisition on the market price of Invitae's common stock
and/or on the companies' respective businesses, financial
conditions, results of operations and financial performance;
significant transaction costs and/or unknown liabilities; the
possibility that the anticipated benefits from the proposed
acquisition of Archer cannot be realized in full or at all or may
take longer to realize than expected; risks associated with
contracts containing consent and/or other provisions that may be
triggered by the proposed acquisition of Archer; risks associated
with transaction-related litigation; the possibility that costs or
difficulties related to the integration of Archer's operations with
those of Invitae will be greater than expected; the ability of
companies individually and the combined company to retain and hire
key personnel; Invitae's failure to manage growth effectively;
Invitae's need to scale its infrastructure in advance of demand for
its tests and to increase demand for its tests; Invitae's ability
to use rapidly changing genetic data to interpret test results
accurately and consistently; security breaches, loss of data and
other disruptions; laws and regulations applicable to Invitae's
business, and the risks and uncertainties set forth in Invitae's
reports on Forms 10-K, 10-Q and 8-K filed with or furnished to the
Securities and Exchange Commission (the "SEC") and other written
statements made by Invitae from time to time. There can be no
assurance that the proposed acquisition of Archer will in fact be
consummated in the manner described or at all. Forward -looking
statements speak only as of the date hereof, and Invitae disclaims
any obligation to update any forward-looking statements.
NOTE: Invitae and the Invitae logo are trademarks of Invitae
Corporation. All other trademarks and service marks are the
property of their respective owners.
Additional Information and Where to Find It
In connection with the proposed transaction, Invitae will file
with the SEC a registration statement on Form S-4, which will
include a document that serves as a proxy statement/prospectus of
Invitae (the "proxy statement/prospectus"), and will file other
documents regarding the proposed transaction with the SEC.
INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE REGISTRATION
STATEMENT, PROXY STATEMENT/PROSPECTUS AND OTHER RELEVANT DOCUMENTS
FILED WITH THE SEC WHEN THEY BECOME AVAILABLE, BECAUSE THEY WILL
CONTAIN IMPORTANT INFORMATION. A definitive proxy
statement/prospectus will be sent to Invitae's stockholders when it
becomes available. Investors and security holders will be able to
obtain the registration statement and the proxy
statement/prospectus free of charge from the SEC's website or from
Invitae when it becomes available. The documents filed by Invitae
with the SEC may be obtained free of charge at Invitae's website at
www.invitae.com or at the SEC's website at www.sec.gov. These
documents may also be obtained free of charge from Invitae by
requesting them by mail at Invitae Corporation, 1400 16th Street,
San Francisco, California 94103,
or by telephone at (415) 374-7782.
Participants in the Solicitation
Invitae and its directors and executive officers and other
members of management and employees may be deemed to be
participants in the solicitation of proxies in connection with the
proposed transaction. Information about Invitae's directors and
executive officers is available in Invitae's proxy statement dated
April 29, 2020 for its 2020 Annual
Meeting of Stockholders. Other information regarding the
participants in the proxy solicitation and a description of their
direct and indirect interests, by security holdings or otherwise,
will be contained in the registration statement, the proxy
statement/prospectus and other relevant materials to be filed with
the SEC regarding the proposed transaction when they become
available. Stockholders, potential investors and other readers
should read the proxy statement/prospectus carefully when it
becomes available before making any voting or investment decisions.
You may obtain free copies of these documents from Invitae as
indicated above.
No Offer or Solicitation
This communication shall not constitute an offer to sell or the
solicitation of an offer to buy any securities, nor shall there be
any sale of securities in any jurisdiction in which such offer,
solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of any such jurisdiction.
No offering of securities shall be made except by means of a
prospectus meeting the requirements of Section 10 of the U.S.
Securities Act of 1933, as amended.
Non-GAAP Financial Measures
Cash burn is a non-GAAP measure, is not based on any
standardized methodology prescribed by GAAP and is not necessarily
comparable to similarly-titled measures presented by other
companies. A limitation of using cash burn is that it does not
represent the total change in cash, cash equivalents, and
restricted cash for a period because it excludes cash provided by
or used for other operating, investing or financing activities.
Management accounts for this limitation by providing information
about Invitae's historical operating, investing and financing
activities in the statements of cash flows in the consolidated
financial statements in its most recent Quarterly Report on Form
10-Q and Annual Report on Form 10-K and by presenting net cash
provided by (used in) operating, investing and financing activities
as well as the net increase or decrease in cash, cash equivalents
and restricted cash in its reconciliation of cash burn with such
financial statements.
Cash burn is calculated as net increase or decrease in cash and
cash equivalents and restricted cash less (a) changes in marketable
securities, (b) cash received from equity and debt financings, (c)
cash received from exercises of warrants, (d) cash payments made
for business acquisitions, and (e) changes in unrealized gains and
losses on marketable securities. A reconciliation to GAAP has not
been provided as the reconciliation could not reasonably be
estimated.
Contact for Invitae:
Laura
D'Angelo
ir@invitae.com
(628) 213-3369
Contact for ArcherDX:
Andrea
N. Flynn, Ph.D.
Investor Relations & Corporate Communications
ir@archerdx.com
1 El-Deiry, W., et al. The current
state of molecular testing in the treatment of patients with solid
tumors, 2019. Cancer J Clin. 2019;69(4): 305-343
2 Hyman DM, et al. Implementing
Genome-Driven Oncology. Cell. 2017;168(4):584–599
3 Benayed, R, et al. High yield of RNA
sequencing for targetable kinase fusions in lung adenocarcinomas
with no driver alteration detected by DNA sequencing and low tumor
mutation burden. Clin Cancer
Res. April 2019.
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SOURCE Invitae Corporation