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.
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.
Contact: Kevin C. O'Boyle EVP & Chief Financial Officer NuVasive, Inc. 858-909-1998 firstname.lastname@example.org Investors: Patrick F. Williams Vice President, Finance & Investor Relations NuVasive, Inc. 858-638-5511 email@example.com Media: Jason Rando The Ruth Group 646-536-7025 firstname.lastname@example.org
|SOURCE NuVasive, Inc.|
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