EXTON, Pa.--(BUSINESS WIRE)--
Fibrocell Science, Inc. (FCSC) reported its financial and operating results for the year ended December 31, 2012.
“2012 has been a pivotal year for Fibrocell,” said David Pernock, Fibrocell Chairman and Chief Executive Officer. In 2012, Fibrocell launched, LAVIV® (azficel-T), an autologous fibroblast cell product indicated for improving the appearance of smile-line wrinkles and the company’s first FDA-approved product. LAVIV has been in the market on a limited basis for the past year and the response from physicians and their patients has been positive. As one of only eight cell-based products approved by the U.S. Food and Drug Administration (FDA), LAVIV is the first and only approved for aesthetic use and is the only one that utilizes the patient’s own fibroblast cells.
Fibrocell is now working to develop a deep and meaningful pipeline of premium, first-in-class products based on its autologous fibroblast technology. To that end, the company has embarked on a collaboration with Intrexon Corporation that will focus on rare genetic collagen deficiencies. The Company also plans to initiate multiple Phase II clinical programs in restrictive burn scars and in vocal cord scars in 2013.
“2012 was clearly a watershed year for Fibrocell. We established the viability of our core fibroblast technology with LAVIV® and are working to unlock its potential in medical and aesthetic areas with significant unmet need,” said Mr. Pernock “Having successfully raised more than $40 million in new capital, we can now pursue additional indications for our autologous fibroblasts in areas with a significant and unmet medical need such as restrictive burn scars, vocal cord scars, and recessive dystrophic epidermolysis bullosa (RDEB). Fibrocell is at and will remain at the leading edge of personalized regenerative medicine. In the coming weeks we intend to provide detail on these activities and others.”
LAVIV continues to receive favorable recognition in national beauty and fashion magazines. It has also received numerous awards for innovation, including recognition in the 12th Annual Wall Street Journal Technology Innovation Awards program.
Commercially, 2012 was devoted to introductory marketing of LAVIV and to helping leading physicians gain clinical experience using this new technology. The introductory price for LAVIV, which is below our cost of manufacturing, was intended to stimulate usage and clinical experience. Now that the product is established in clinical practice, we will announce a price increase later this month that better reflects its market value.
--As of December 31, 2012, cash and cash equivalents were $31.3 million compared to $10.8 million a year ago.
--For the year ended December 31, 2012, Fibrocell posted a net loss of $23.2 million on revenue of $153,000 compared to a net loss of $31.4 million on zero revenue for the year ended December 31, 2011.
--Fibrocell sold greater than $40 million in new equity in October 2012. As a part of the transaction, the company repaid or converted to equity all of its outstanding debt and all preferred shares were converted to common shares. The company currently has no debt.
Product Pipeline Highlights
LAVIV has validated the utility and commercial importance of our core technology. We are now in a position to apply our knowledge of the autologous cell manufacturing processes and regulatory requirements toward the development and commercialization of autologous products for new medical and aesthetic applications where autologous fibroblasts could play a key role. We are particularly focused on indications that present a critical unmet need and offer significant market and reimbursement potential. We will leverage the same core technology and manufacturing process to improve the lives of patients beyond our current aesthetic indication. The following programs demonstrate our work towards broadening the potential of our autologous fibroblast technology platform:
Rare Collagen Deficiencies -- Fibrocell has entered into an Exclusive Channel Collaboration (ECC) with Intrexon Corporation to explore the use of genetically modified autologous fibroblasts cells for the treatment of the genetic blistering disorder epidermolysis bullosa (EB), and more specifically, recessive dystrophic epidermolysis bullosa (RDEB), the most severe form of the disease. RDEB is an autosomal recessive disorder characterized by the loss of collagen type VII, an important protein component of the anchoring fibers that connect the dermis to the epidermis.
RDEB typically presents at birth, and affected children experience widespread blistering and areas of missing skin in response to friction or minor injury, such as rubbing, scratching, or abrasions. Severe cases can lead to disfigurement through fusion of the fingers and toes, muscle contractures that restrict movement, corneal inflammation or scarring leading to vision loss, anemia, and other serious medical problems. RDEB has the highest rate of morbidity and mortality amongst the genetic blistering disorders. RDEB patients who survive to adulthood most often succumb to cutaneous squamous cell carcinoma.
Through its collaboration with Intrexon, Fibrocell is uniquely positioned to leverage its proven fibroblast technology with Intrexon’s synthetic biology expertise to modify a patient’s own fibroblasts in order to produce functional collagen VII. A patient’s own gene modified fibroblasts hold the potential to treat this rare genetic condition by partially restoring normal collagen VII production and thus establishing physiological dermal-epidermal junctions. The availability of such a treatment would address a significant unmet clinical need given approximately 7 in 1,000,000 live births in the US, Europe, and Asia are diagnosed with RDEB. Presently there are no FDA-approved products to treat the underlying cause of the disease, and clinicians and patients must rely solely on palliative care to reduce patient suffering.
Restrictive Burns Scars -- Approximately 45,000 people in the United States are hospitalized each year with severe burns, leaving many with restrictive burn scars that can cause disfigurement, decreased mobility and continuous pain. We believe that the intrinsic role fibroblasts play in wound healing could be applied to these patients to help improve their range of motion and reduce scar pain. In the second quarter of 2013 we plan to start a Phase II trial of our autologous fibroblast technology for the treatment of restrictive burns scars to assess impact on range of motion, pain and scar appearance. Because there are currently no FDA-approved products to treat restrictive burn scars, commercialization of such a treatment would be a significant breakthrough in the market.
Vocal Cord Scars -- Scar tissue on the vocal cords reduces their suppleness and can affect voice tone and loudness; in fact, extreme scarring can leave impacted individuals unable to verbally communicate. Vocal cord scarring can be caused by aging, excessive exertion (such as experienced by singers and public speakers) and is a frequent side effect of cancer radiation therapy and surgical trauma. It impacts an estimated 200,000 to 700,000 people in the United States. Restoration of normal collagen levels may enable vocal cords to regain their lost suppleness. Our pilot clinical study showed that the injection of autologous fibroblasts is safe and appears to produce both objective and subjective improvements in voice quality that were sustained up to 12 months after treatment. In furthering this research, we plan to commence a Phase II study of our autologous fibroblast cell technology for vocal cord scars in the second half of 2013. We will be assessing improvement in voice quality. With voice therapy the most common attempted remedy and no commercially available treatments to date, we believe this could present a lucrative new application for our autologous fibroblast technology.
Acne Scars -- Acne is the most common skin disorder in the United States and leaves an estimated 20 million Americans suffering from acne scarring as a result. Following the completion of a successful Phase II study of our autologous fibroblast technology for the treatment of moderate to severe acne scars, which met all efficacy end points and was well tolerated by participants, we entered discussions with the FDA regarding the design of a Phase III program. Presently there are no FDA-approved medical products for the treatment of acne scarring. Given the promising early results, we are eager to further examine the potential value our autologous fibroblast technology could provide in this widespread condition.
Skin-derived Stem Cell Initiatives/UCLA/MIT -- We entered into an exclusive license agreement with UCLA to develop methods and techniques for using skin cells for generating stem cells that could serve as versatile tissue progenitors in regenerative medicine applications.
Under our collaborative agreement with MIT, researchers there are working to develop a scalable method to cost-effectively culture and grow the cell types identified by UCLA into relevant quantities.
Fibrocell Science Autologous Crème™ -- We initiated a marketing claims study of a new autologous skin care cream for treating mild to severe photo-damaged skin. The cream will leverage the LAVIV manufacturing process, providing the first and only topical product containing personalized growth factors and proteins derived from a person’s own fibroblast cells. We expect to introduce the product in the second half of 2013 under the name Fibrocell Science Autologus Crème™.
About Fibrocell Science, Inc.
Fibrocell Science, Inc. (FCSC) is an autologous cellular therapeutic company focused on the development of innovative products for aesthetic, medical and scientific applications. Fibrocell Science is committed to advancing the scientific, medical and commercial potential of autologous skin and tissue, as well as its innovative cellular processing technology and manufacturing excellence. For additional information, please visit www.fibrocellscience.com.
All statements in this press release that are not based on historical fact are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include, without limitation, (a) the Company’s ability to build on its core technology and expand its development portfolio to include treatments for restrictive burn scars, vocal cord scars, and rare genetic collagen deficiencies; (b) the Company’s ability, through its collaboration with Intrexon Corporation to leverage its fibroblast technology to provide a potential treatment for RDEB that would enable normal collagen production; (c) the Company’s ability to start a Phase II trial for the treatment of restrictive burns scars in the second quarter of 2013; (d) the Company’s ability to start a Phase II study for vocal cord scars in the second half of 2013; and (e) the Company’s ability to introduce its autologous skin care crème product in the second half of 2013. While management has based any forward-looking statements contained herein on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties, and other factors, many of which are outside of the Company’s control, that could cause actual results to materially differ from such statements. Such risks, uncertainties, and other factors include, but are not necessarily limited to, those set forth under Item 1A “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2012, as updated in “Item 1A. Risk Factors” in the Company’s Quarterly Reports on Form 10-Q filed since the annual report. The Company operates in a highly competitive and rapidly changing environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. The Company disclaims any intention to, and undertakes no obligation to, update or revise any forward-looking statements. Readers are also urged to carefully review and consider the other various disclosures in the Company’s public filings with the SEC.
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