Long Term Supply of Osteocel(R) Plus Solidified Without Ownership of Processing Facility
March 30 2009 - 7:00AM
PR Newswire (US)
SAN DIEGO, March 30 /PRNewswire-FirstCall/ -- NuVasive, Inc.
(NASDAQ: NUVA), a medical device company focused on developing
products for minimally disruptive surgical treatments for the
spine, announced today that due to the successful scale-up of the
supply of Osteocel, NuVasive has accelerated the transfer of the
processing of Osteocel Plus from Osiris Therapeutics (NASDAQ: OSIR)
to its own exclusive supply chain. Since the May 2008 announcement
of the original transaction, the companies have successfully worked
to increase production and transfer the technical know-how and
related intellectual property to NuVasive. Due to NuVasive's
confidence in its ability to supply product to support its planned
sales growth of Osteocel Plus, the companies have decided to
eliminate the performance contingencies applicable to $30 million
of the $45 million in remaining milestones. The $30 million in
milestones is scheduled to be paid as follows: Date of Payment
Payment Value March 31, 2009 $5.0M June 30, 2009 $12.5M September
30, 2009 $12.5M Total $30.0M The terms applicable to the remaining
$15 million milestone payment, which is due upon NuVasive achieving
$35 million in cumulative sales of Osteocel, remain unchanged. To
date, NuVasive has made a total of $40 million in up-front and
milestone payments. The total potential consideration of $85
million remains unchanged. Under the new terms, NuVasive
immediately assumes control of production. NuVasive has selected
AlloSource as its exclusive supplier of Osteocel Plus. AlloSource
is one of the nation's largest tissue providers and has already
started supplying Osteocel Plus. AlloSource has been working to
scale up its production since last summer and NuVasive expects the
AlloSource supply relationship to provide an efficient and
consistent stream of supply. NuVasive will not assume ownership of
the Osiris tissue processing facility. NuVasive reiterates its
previous guidance of $28 million in Osteocel Plus revenue in 2009
with no change in profitability targets. NuVasive notes that the
transfer of processing will support its ability to meet or exceed
2009 Osteocel Plus sales goals and fuel anticipated revenue growth
to $100 million and beyond. About NuVasive NuVasive is a medical
device company focused on the design, development and marketing of
products for the surgical treatment of spine disorders. The
Company's product portfolio is focused on applications in the over
$4.6 billion U.S. spine fusion market. The Company's current
principal product offering includes a minimally disruptive surgical
platform called Maximum Access Surgery, or MAS(R), as well as a
growing offering of biologics, cervical and motion preservation
products. The MAS platform offers advantages for both patients and
surgeons such as reduced surgery and hospitalization time and
faster recovery. MAS combines three categories of current product
offerings: NeuroVision(R) a proprietary software-driven nerve
avoidance system; MaXcess(R) a unique split-blade design retraction
system; and specialized implants, like SpheRx(R) and CoRoent(R),
that collectively minimize soft tissue disruption during spine
surgery while allowing maximum visualization and surgical
reproducibility. NuVasive's product offering is also focused on
cervical internal fixation products and its R&D pipeline
emphasizes both MAS and motion preservation. NuVasive's Biologic
product portfolio includes FormaGraft(R), Osteocel Plus, and the
Progentix products, all of which are intended to facilitate fusion
and complement the core fixation products. NuVasive cautions you
that statements included in this press release that are not a
description of historical facts are forward-looking statements that
involve risks, uncertainties, assumptions and other factors which,
if they do not materialize or prove correct, could cause NuVasive's
results to differ materially from historical results or those
expressed or implied by such forward-looking statements. The
potential risks and uncertainties that could cause actual growth
and results to differ materially include, but are not limited to:
the risk that NuVasive revenue projections may prove incorrect
because of unexpected difficulty in generating sales or achieving
anticipated profitability; the risk that NuVasive may encounter
unanticipated difficulty integrating the Osteocel product into its
product line; the risk that NuVasive may be unable to generate
expected revenues from Osteocel; the uncertain process of seeking
regulatory approval or clearance for NuVasive's products of
devices, including risks that such process could be significantly
delayed; the possibility that the FDA may require significant
changes to NuVasive's products or clinical studies; the risk that
products may not perform as intended and may therefore not achieve
commercial success; the risk that competitors may develop superior
products or may have a greater market position enabling more
successful commercialization; the risk that additional clinical
data may call into question the benefits of NuVasive's products to
patients, hospitals and surgeons; and other risks and uncertainties
more fully described in NuVasive's press releases and periodic
filings with the Securities and Exchange Commission. NuVasive's
public filings with the Securities and Exchange Commission are
available at http://www.sec.gov/. NuVasive assumes no obligation to
update any forward-looking statement to reflect events or
circumstances arising after the date on which it was made. Contact:
Kevin C. O'Boyle EVP & Chief Financial Officer NuVasive, Inc.
858-909-1998 Investors: Patrick F. Williams Vice President, Finance
& Investor Relations NuVasive, Inc. 858-638-5511 Media: Jason
Rando The Ruth Group 646-536-7025 DATASOURCE: NuVasive, Inc.
CONTACT: Kevin C. O'Boyle, EVP & Chief Financial Officer of
NuVasive, Inc., +1-858-909-1998, , or Investors, Patrick F.
Williams, Vice President, Finance & Investor Relations of
NuVasive, Inc., +1-858-638-5511, ; or Media, Jason Rando of The
Ruth Group, +1-646-536-7025, , for NuVasive, Inc.
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