Supernus Pharmaceuticals,
Inc. SUPN is providing the following business update in light of
recent investor filings with the SEC:
* The Company reaffirms that it is on track to become cash flow breakeven by
year-end, with a year-end cash balance of $75 million - $85 million.
* The Company reaffirms that it does not need to raise additional capital to
reach profitability. It expects to be profitable starting in 2014 and
beyond.
* The Company reaffirms that it expects revenues of approximately $105
million in 2014.
The Company is focused on executing its current strategy as outlined below to
maximize shareholder value.
Drive growth in its epilepsy portfolio of products, Trokendi XR^® and Oxtellar
XR^®.
The products, successfully launched last year, are in their early stage of
growth, with total peak sales potential of $400 million to $500 million. The
Company continues to strengthen its intellectual property position on both
products with four patents covering Oxtellar XR and three patents covering
Trokendi XR with expiry that is no earlier than 2027. Additional patent
applications are in process to ensure that the products are covered by the
full scope of patent protection to which they are entitled.
Demonstrate significant progress in the development of our pipeline.
This is evident by the recent FDA fast track designation on SPN-810 and the
selection of the sustained release formulation on SPN-812. The Company has
also completed significant work on: the development and manufacturing of the
active drug substance; development and manufacturing of product formulations,
and preclinical testing including two year carcinogenicity and several
toxicology studies.
The Company's pipeline targets markets with significant commercial potential.
SPN-810 is expected to be the first product approved for impulsive aggression
that is prevalent across many CNS disorders including ADHD, autism, bipolar,
and schizophrenia, and for which there are currently no approved products on
the market. Similarly, SPN-812 is expected to have a differentiated clinical
profile compared to other non-stimulants for the treatment of ADHD. Both
products have successfully progressed and have completed multiple trials
leading to the planned 2015 start of patient dosing in Phase III for SPN-810
and patient dosing in Phase IIb for SPN-812. The Company is also building a
broad portfolio of patents to provide strong intellectual property protection
on both products.
Explore a broad range of strategic opportunities.
This includes in-licensing products and entering into co-promotion
partnerships which are synergistic with our neurology sales force call point,
potential co-development partnerships on our pipeline products, and growth
opportunities through value-creating and transformative merger and acquisition
transactions.
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