“2015 was a transformational year for Osiris, as we completed the transition from an R&D focused biotech firm to a commercial enterprise,” said Lode Debrabandere, Ph.D., President and CEO of Osiris. “In the interest of providing investors and other stakeholders further context of these changes and their impact – as well as responding to certain statements about the company recently posted to several websites – a recap of some of the 2015 activities is appropriate.”
Select operational highlights of 2015:
- Established a competitive commercial infrastructure, achieved insurance coverage for over 135 million lives (including 90% of Medicare lives) and signed a major contract with a group purchasing organization (GPO) and multiple integrated delivery networks (IDNs). These activities resulted in significant market penetration and share gains for Grafix in the wound care market. Given the progress made throughout 2015 as it relates to the growth of the overall Grafix business, use of dated 2014 external data (i.e. 2014 Medicare data) is clearly not reflective of Osiris’ Grafix sales in 2015. The referenced 2015 estimates by independent third-party entities, such as BioMedGPS’ SmartTRAK®, provide a more realistic and accurate estimate of Osiris’ current sales and market share in wound care.
- Established important distribution relationships with industry-leading marketing partners. These include an exclusive worldwide partnership with Stryker who now markets BIO4®, a viable bone matrix, and with Arthrex, the distribution partner for Osiris’ Cartiform® product, a viable osteochondral allograft.
- Transitioned Stability Biologics® from being a meaningful revenue contributor to Osiris in previous years, as disclosed in our filings, to contributing less than 0.5% of revenue in the second half of 2015.
Additionally, on December 14, 2015, Osiris received written notice of resignation from BDO USA LLP, the company’s independent registered public accounting firm, which the company disclosed on December 17, 2015, within the time period prescribed by SEC rules. Notwithstanding the resignation, BDO continues to perform procedures to complete the company’s previously announced amended filings and to ensure a smooth transition to our successor accounting firm.
Lastly, although the company does occasionally provide updates and clarifications such as the foregoing, Osiris may not be aware of, and may not respond to, all current or future statements posted or published externally by third parties.
About Osiris Therapeutics
Osiris Therapeutics, Inc., based in Columbia, Maryland, is a leader in researching, developing and marketing cellular regenerative medicine products that improve the health and lives of patients and lower overall healthcare costs. Having developed the world’s first approved stem cell drug, Osiris works to further advance the medical field. Osiris’ research and development in biotechnology focuses on innovation in regenerative medicine – including bioengineering, stem cell research and viable tissue based products. Osiris has achieved commercial success with products in orthopaedics, sports medicine and wound care, including BIO4, a viable bone matrix, Cartiform, a viable osteochondral allograft, Grafix, a cryopreserved placental membrane, TruSkin™, a viable human skin allograft and Stravix™, a durable placental allograft.
Osiris, Grafix, and Cartiform are registered trademarks of Osiris Therapeutics, Inc.; TruSkin and Stravix are trademarks of Osiris Therapeutics, Inc. BIO4 is a registered trademark of Stryker Corporation (NYSE: SYK). More information can be found on the company's website, www.Osiris.com. (OSIR-G)
This press release contains forward-looking statements. Forward-looking statements include statements about our expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Words or phrases such as "anticipate," "believe," "continue," "ongoing," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project" or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Examples of forward-looking statements may include, without limitation, statements regarding any of the following: our product development efforts; our clinical trials and anticipated regulatory requirements, and our ability to successfully navigate these requirements; the success of our product candidates in development; status of the regulatory process for our biologic drug candidates; implementation of our corporate strategy; our financial performance; our product research and development activities and projected expenditures, including our anticipated timeline and clinical strategy biologic drug candidates and marketed Biosurgery products (including Grafix, BIO4, Cartiform, TruSkin and Stravix); our cash needs; patents, trademarks and other proprietary rights; the safety and ability of our products and potential products to treat disease; our ability to supply a sufficient amount of our marketed products or product candidates and, if approved or otherwise commercially available, products to meet demand; our costs to comply with governmental regulations; our plans for sales and marketing; our plans regarding facilities; types of regulatory frameworks we expect will be applicable to our products and potential products; results of our scientific research; the timing of our amended 2015 filings; and the engagement of our successor accounting firm. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. Our actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the section entitled "Risk Factors" in our Annual Report on Form 10-K and other Periodic Reports filed on Form 10-Q, with the United States Securities and Exchange Commission. Accordingly, you should not unduly rely on these forward-looking statements. We undertake no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this press release or to reflect the occurrence of unanticipated events.