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
Date of Payment Payment Value
March 31, 2009$5.0MJune 30, 2009$12.5MSeptember 30, 2009$12.5M
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
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 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.
Kevin C. O'Boyle
EVP & Chief Financial Officer
Patrick F. Williams
Vice President, Finance & Investor Relations
The Ruth Group
SOURCE NuVasive, Inc.