STDY (MC $ 35M) NDA filing in 2H for MEGA Orphan Drug = Lifetime Opportunity

This Undiscovered ultra low float stock could be a Once in a Lifetime Opportunity please do your own dd and realize the MEGA Potential here .

SteadyMed (STDY) is a undiscovered stock which is close to NDA & EMA filing (expected in 4Q 2016) for their Big Orphan Drug called Trevyent? for the treatment of pulmonary arterial hypertension (PAH) . SteadyMed is trading almost at Cash Level and lots of Insider & Institutions paid over $8 per Share now trading at just $2.50 more Infos below .I think this Stock really has MEGA upside Potential .GL

SteadyMed (Nasdaq: STDY)


Market Cap: $34.9 Million
Cash: $31.8 Million
Price: $2.57

Shares Out : 13.58 Million

Insiders & Institutions holding 10.8 Million Shares

Trevyent? for pulmonary arterial hypertension (PAH)

• Combination of treprostinil and our PatchPump? platform technology
- Goal - to overcome the limitations of market leader Remodulin? (treprostinil)
- Expected NDA filing in Q3 2016
• Potential high revenue, high margin ~$180,000 per patient per year
• Potential >$4 Billion addressable market opportunity in U.S.


Bio-waiver confirmed – No clinical studies required for approval
• 505(b)(2) NDA in the U.S.
• Hybrid 10(3) Application in the E.U. - granted Centralized Review by EMA
NDA submission anticipated Q3 2016 and E.U. MAA H2 2016
Remodulin safety and efficacy data to be included in Trevyent prescribing
information
Example of FDA product approvals through bio-waiver
• Parenteral epoprostenol reformulation (Veletri?, Actelion) for PAH

Pipeline of two At-Home Patient Analgesia (AHPA) product candidates

• SMT – 201 (Ketorolac). Anticipate pivotal / registration trial H2 2016

• SMT – 301 (Bupivacaine.) Formulation development and technical feasibility ongoing

Given that the drug is used to treat an orphan market, the profit margin for treatment in this arena is typically very high. Other orphan drugs markets can yield profit margins in the range of 20-40%. Given company estimates, the capital raised from the IPO would be enough to support approval and the final stages of development behind Trevyent. Using the conservative end of margins, 20%, and 10% market share, possible earnings would be $90 million. Then using the high growth 30x price-earnings ratio for the pharmaceutical industry, the resulting market valuation would be around $2.7 billion.

Trevyent could reach 10% market share very quickly. For example, leading competitor, Remodulin, manufactured by United Therapeutics (NASDAQ:UTHR) was approved for market in December 2013. It reached 10% share within 12 months. Given the advantages of SteadyMed's product, it should be able to at least replicate these results given the market is still largely untreated.

The Pipeline

SteadyMed's flagship drug, Trevyent, is currently in late-stage development and obtaining final approvals before going to market. The drug could treat up to 30,000 patients that suffer from PAH in the US annually. Currently, very few alternative treatments exist for PAH. The leading competitor currently only has an estimated market share of 10%. Most patients, about 80-90%, do not undergo treatment due to the difficult, cumbersome nature of the current treatment options. Trevyent and the proprietary PatchPump device promise to significantly reduce the burden of treatment, and increase accessibility. Finally, the Trevyent-PatchPump combo secures a larger share of revenue since SteadyMed sells both the drug and device. Treatment costs currently average $125k to $175k. If SteadyMed can even fetch the midpoint of this range, at a 10% market share Trevyent would be generating $450 million in sales. And, at 50% share, the drug could be a $2.3 billion drug.

Seems somewhat promising, but I'm still not convinced. Are you sure about that high profit margin? To me this doesn't really make sense...