Steadymed Ltd. (Nasdaq:STDY)
Steadymed Ltd. (NASDAQ:STDY) shares rocketed today following Friday’s rally of almost 50%. The thinly traded biotech firm normally has around 19,650 shares traded on average but today by 10AM EST, over 3.5 million shares had traded hands. The catalyst for the increased volume and share price was a favorable ruling by the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO).
In April of 2016, Steadymed Ltd. (NASDAQ:STDY) challenged, in an Inter Partes Review (IPR), the validity of patent no. 8,497,393 (’393) awarded to United Therapeutics. The ‘393 patent claims a product made by a process to further purify prostacyclin derivatives, such as treprostinil. Treprostinil is the active pharmaceutical ingredient used in United Therapeutics’ Remodulin® and SteadyMed’s lead drug candidate, Trevyent, which is in development for the treatment of Pulmonary Arterial Hypertension (PAH). In its ruling, the PTAB found all 22 claims in the ‘393 patent unpatentable and cancelled them, rendering United Therapeutic’s patents invalid. Steadymed Ltd. (NASDAQ:STDY) has also reiterated guidance that it will file a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for Trevyent by the end of Q2 2017.
San Ramon, CA-based Steadymed Ltd. (NASDAQ:STDY) intends to commercialize Trevyent in the U.S. and has signed an exclusive license and supply agreement with Vancouver, Canada-based Cardiome Pharma Corp. for the commercialization of Trevyent in Europe, Canada and the Middle East.
Jonathan Rigby, President and Chief Executive Officer of Steadymed Ltd. (NASDAQ:STDY) commented “We continue to focus on completing the final steps ahead of submitting our New Drug Application (NDA) for Trevyent, for the treatment of PAH, by the end of the second quarter. We have a growing body of market research data that we believe strongly indicates a significant need for Trevyent that, if approved, has the potential to take a meaningful share of the PAH market.”
For the year ended December 31, 2016, Steadymed Ltd. (NASDAQ:STDY) reported a net loss of $25.9 million, or $1.59/share, which represented an improvement over 2015’s net loss of $25.0 million, or $2.45/share. The current year’s calculation of loss per share is based on 16,253,975 weighted-average shares outstanding, versus 10,593,227 outstanding shares in the prior-year period. Sales also improved in 2016 to $1.1 million from $900,000 in 2015. Meanwhile the shares outstanding were reduced, in 2016, to 10.59 million from 12.25 million in 2015. The financial improvements have been reflected in STDY’s returns. YTD, shares of STDY are up over 123% and up over 135% for the year. HC Wainwright is the only firm that covers Steadymed Ltd. (NASDAQ:STDY). It rates shares of STDY as a “Strong Buy” with a $10 price target.
|Last Price a/o 10:28 AM EST||$ 7.95|
|Market Cap (mlns)||$ 118.38|
|Shares Outstanding (mlns)||20.41|
|Share Float (mlns)||12.83|
|Short Interest Ratio||1.03|
I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.
About the author: Steve Clark is a 23-year Wall St professional with stints in M&A, risk management, and algorithm trading.