TherapeuticsMD Inc (NYSEMKT:TXMD)
TherapeuticsMD Inc (NYSEMKT:TXMD) CEO Robert Finizio discussed Q4 2016 results, wherein he stated that 2016 was a remarkable year for the company. Their two late stage product offerings, TX-001HR and TX-004HR, continue to approach commercialization and are supported by two clinically rigorous advancement plans and a promising Phase 3 report.
Finizio reported that in July, the company submitted their new drug application for their first product candidate ‘TX-004HR’ based upon a promising report from the pivotal Phase III Rejoice study. The product applied for NDA status in September 2016 and they obtained a PDUFA target action date for May. Assuming approval, they intend to release TX-004HR in Q4 2017.
More recently, TherapeuticsMD Inc (NYSEMKT:TXMD) released a promising topline report from the pivotal Phase III Replenish study for a second product candidate, ‘TX-001HR’, the bio-identical combination of progesterone and estradiol for moderate-to-severe vasomotor indications due to menopause.
The company considers TX-001HR to have prospects to become the first FDA permitted bio-identical combination of progesterone and estradiol – an extremely valuable treatment alternative in the large growing and underserved industry for bio-identical hormone treatment.
Market prospects for TX-001HR continue to expand. There are more than 6 million yearly FDA approved prescriptions and close to 18 million yearly compounded prescriptions. TherapeuticsMD Inc (NYSEMKT:TXMD) association with potential distribution associates in the compounding pharmacy community has been strengthening via BIO-IGNITE program.
Finally, the company continued to appropriately expand its commercial infrastructure and sales to prepare for the potential release of TX-004HR. They have made considerable progress towards this objective including hiring of Dawn Halkuff as Chief Commercial Officer. The sales team has recorded a remarkable job building their prenatal vitamin commerce into the leading list of prenatal offerings by volume.
Finizio added that they consider they have the sale infrastructure in place and the established associations in the OBGYN channel to lead a successful release of TX-004HR if permitted. For Q4 2016, net revenue from the firm’s prescription prenatal vitamin unit was almost $4.5 million for Q4 2016 as against almost $5.6 million in the same quarter, a year ago.
With all other factors in place, TherapeuticsMD Inc (NYSEMKT:TXMD) has been on a run, surging 7.54% in merely three months. It seems like traders are delighted with the stock as analysts consider it a “buy”.
|Last Price a/o 3:21 PM EST||$6.42|
|Market Cap (mlns)||$1.27B|
|Shares Outstanding (mlns)||197.52M|
|Share Float (mlns)||154.94M|
|Short Interest Ratio||29.31|
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: Monica Gray has an undergraduate degree in Accounting and an MBA – earned with Honors. She has six years of experience in the financial markets and has been a securities analyst for the past two years.