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Histogenics Corporation Announces Fourth Quarter and Full Year 2014 Financial Results
"2014 was a transformative year for
Financial Results for the Fourth Quarter and Full Year 2014
For the fourth quarter of 2014,
For the fourth quarter of 2014, selling, general and administrative expenses were
For the fourth quarter of 2014, research and development expenses were
2014 Operational Highlights
- Re-initiation of its NeoCart® Phase 3 clinical trial in early 2014, and completion of all site start-up and training activities for approximately 30 investigational sites.
Initiation of its critical raw material technology transfer project in the spring of 2014, where it will source and supply the critical raw materials used in the manufacture of NeoCart®.
Histogenicshas completed its initial engineering runs and initial validation studies for its additional facility in Lexington, Massachusetts, which has been operational since October 2014.
Execution of an Exclusive Channel Collaboration with
Intrexon Corporationin September 2014to develop next-generation cartilage products, increase Histogenics'future manufacturing capabilities and capacity, and accelerate its platform technology pipeline initiatives.
Submission of a protocol amendment in
November 2014to its NeoCart® Phase 3 clinical trial to augment addition Health Economics Outcomes Researchdata, intended to further support its future reimbursement initiatives, including collecting key economic data and outcomes associated with quality of life, productivity and return to work status, and healthcare resource utilization related to direct and indirect costs.
Histogenicsreceived preliminary feedback and general acceptance of its raw material transition strategy and future commercial readiness upgrades from the U.S. Food and Drug Administration( FDA) in December 2014.
Subsequent Events in 2015
David Gilljoined Histogenics'Board of Directors in February 2015, and will chair Histogenics'Audit Committee of its Board of Directors.
"Looking forward, we believe that 2015 will be a pivotal year for
Conference Call Information
To participate on the live call, please dial (877) 930-8064 (domestic) or (253) 336-8040 (international) and provide the conference ID 83728349 five to ten minutes before the start of the call.
A live audio webcast of the presentation will be available via the "Investor Relations" page of the
Forward -Looking Statements
Various statements in this release, including, but not limited to, the guidance provided under "2015 Financial Guidance" above, are "forward-looking statements" under the securities laws. Words such as, but not limited to, "anticipate," "believe," "can," "could," "expect," "estimate," "design," "goal," "intend," "may," "might," "objective," "plan," "predict," "project," "target," "likely," "should," "will," and "would," or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.
Important factors that could cause actual results to differ materially from those reflected in the Company's forward-looking statements include, among others: the timing and success of
There can be no assurance that the actual results or developments anticipated by
All written and verbal forward-looking statements attributable to
|Consolidated Balance Sheet Data|
|Cash and cash equivalents||$ 58,060||$ 8,734|
|Total current assets||58,856||10,346|
|Total current liabilities||8,251||5,087|
|Net sales distribution payment liability||--||13,100|
|Total stockholders' equity (deficit)||54,206||(75,554)|
|Consolidated Statements of Operations Data|
|(in thousands, except share and per share data)|
For the Three Months
Ended December 31,
For the Twelve Months Ended
|Revenue||$ --||$ --||$ --||$ 8|
|Research and development||4,576||3,540||25,856||11,946|
|Selling, general and administrative||1,903||1,917||6,746||4,847|
|Impairment of goodwill and intangible assets||60||60||60||60|
|Total operating expenses||6,539||5,517||32,662||16,853|
|Loss from operations||(6,539)||(5,517)||(32,662)||(16,845)|
|Other income (expense):|
|Interest expense, net||(132)||--||(151)||--|
|Other expense, net||19||(23)||13||(52)|
|Gain on extinguishment of debt||10,007||--||10,007||--|
|Change in fair value of warrant liability, other liability and net sales distribution payment liability||(2,435)||(8,619)||--||(8,815)|
|Total other income (expense), net||7,459||(8,642)||9,869||(8,867)|
|Net loss||$ 920||$ (14,159)||$ (22,793)||$ (25,712)|
|Earnings (loss) attributable to common stockholders - basic||$ 9,622||$ (42,673)||$ (10,510)||$ (56,003)|
|Earnings (loss) attributable to common stockholders - diluted||$ 9,586||$ (42,673)||$ (10,510)||$ (56,003)|
|Earnings (loss) per common share - basic||$ 2.23||$ (73.35)||$ (6.85)||$ (96.58)|
|Earnings (loss) per common share - diluted||$ 1.70||$ (73.35)||$ (6.85)||$ (96.58)|
|Weighted-average shares used to compute loss per common share - basic||4,309,880||581,770||1,534,108||579,849|
|Weighted-average shares used to compute loss per common share - diluted||5,602,759||581,770||1,534,108||579,849|
Elissa CoteTel: +1 (781) 547-7900 InvestorRelations@histogenics.com