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United Therapeutics' PAH Suite Bodes Well, Competition Rife
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On Dec 29, 2016, we issued an updated report on United Therapeutics Corporation (UTHR - Free Report) .
United Therapeutics posted better-than-expected earnings in the third quarter of 2016 even though revenues missed estimates. Nevertheless, its top line also improved on a year-over-year driven by robust sales of its pulmonary arterial hypertension (PAH) products – Adcirca, Tyvaso, Orenitram and Remodulin.
United Therapeutics’ one-month share price movement shows that the stock has significantly outperformed the Zacks classified Medical – Drugs industry. Specifically, the company gained 13.8% during this period, while the industry gained 1.1%.
United Therapeutics holds a strong position in the PAH market with as many as four approved products. The PAH market is highly attractive given the low diagnosis rate, low penetration of existing therapies and significant unmet medical need.
The company’s lead product, Remodulin, was recently launched in new geographies including Japan and China. The company is also working with its partner, Medtronic plc (MDT - Free Report) , for the FDA approval of an implantable pump for delivering Remodulin (RemoSynch). Medtronic’s catheter, which is a component of the RemoSynch system, is presently under FDA review with a PDUFA action date of Apr 10, 2017. United Therapeutics expects to launch the RemoSynch system in the first half of 2017.
Orenitram, its newest PAH offering, is witnessing robust uptake on the back of patient starts, increasing referrals, and higher use in community centers. The company expects to generate revenues of $2 billion annually by 2020.
Moreover, United Therapeutics’ progress on its pipeline has been quite impressive. At present, it has six ongoing phase III or registration design studies, along with a number of phase II or early-stage programs. The phase III trials include oral combination therapy of Orenitram (FREEDOM-EV), Tysuberprost (esuberaprost in combination with Tyvaso) and Tyvaso-ILD (Tyvaso being evaluated in patients with PAH associated with interstitial lung disease). The company plans to file for EU approval for Orenitram once the FREEDOM-EV study has been completed. In addition, the company is evaluating OreniLeft and OreniLeft in phase III trials for PAH.
On the flip side, Remodulin, which accounted for 37.3% of the company’s total sales in the third quarter of 2016, could start facing generic threats post Oct 2017.
In fact, competition is a major concern for United Therapeutics. The majority of PAH patients start out on oral ETRA treatments that include Actelion Ltd.’s Tracleer or Gilead Sciences Inc.’s (GILD - Free Report) Letairis.
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United Therapeutics' PAH Suite Bodes Well, Competition Rife
On Dec 29, 2016, we issued an updated report on United Therapeutics Corporation (UTHR - Free Report) .
![](https://staticx-tuner.zacks.com/images/zadmin_tuner_image/uthr_2016_12_29.jpg)
United Therapeutics posted better-than-expected earnings in the third quarter of 2016 even though revenues missed estimates. Nevertheless, its top line also improved on a year-over-year driven by robust sales of its pulmonary arterial hypertension (PAH) products – Adcirca, Tyvaso, Orenitram and Remodulin.
United Therapeutics’ one-month share price movement shows that the stock has significantly outperformed the Zacks classified Medical – Drugs industry. Specifically, the company gained 13.8% during this period, while the industry gained 1.1%.
United Therapeutics holds a strong position in the PAH market with as many as four approved products. The PAH market is highly attractive given the low diagnosis rate, low penetration of existing therapies and significant unmet medical need.
The company’s lead product, Remodulin, was recently launched in new geographies including Japan and China. The company is also working with its partner, Medtronic plc (MDT - Free Report) , for the FDA approval of an implantable pump for delivering Remodulin (RemoSynch). Medtronic’s catheter, which is a component of the RemoSynch system, is presently under FDA review with a PDUFA action date of Apr 10, 2017. United Therapeutics expects to launch the RemoSynch system in the first half of 2017.
Orenitram, its newest PAH offering, is witnessing robust uptake on the back of patient starts, increasing referrals, and higher use in community centers. The company expects to generate revenues of $2 billion annually by 2020.
Moreover, United Therapeutics’ progress on its pipeline has been quite impressive. At present, it has six ongoing phase III or registration design studies, along with a number of phase II or early-stage programs. The phase III trials include oral combination therapy of Orenitram (FREEDOM-EV), Tysuberprost (esuberaprost in combination with Tyvaso) and Tyvaso-ILD (Tyvaso being evaluated in patients with PAH associated with interstitial lung disease). The company plans to file for EU approval for Orenitram once the FREEDOM-EV study has been completed. In addition, the company is evaluating OreniLeft and OreniLeft in phase III trials for PAH.
On the flip side, Remodulin, which accounted for 37.3% of the company’s total sales in the third quarter of 2016, could start facing generic threats post Oct 2017.
In fact, competition is a major concern for United Therapeutics. The majority of PAH patients start out on oral ETRA treatments that include Actelion Ltd.’s Tracleer or Gilead Sciences Inc.’s (GILD - Free Report) Letairis.
UTD THERAPEUTIC Price and Consensus
UTD THERAPEUTIC Price and Consensus | UTD THERAPEUTIC Quote
Zacks Rank
United Therapeutics currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks here.
Zacks' Top Investment Ideas for Long-Term Profit
How would you like to see our best recommendations to help you find today’s most promising long-term stocks? Starting now, you can look inside our portfolios featuring stocks under $10, income stocks, value investments and more. These picks, which have double and triple-digit profit potential, are rarely available to the public. But you can see them now. Click here >>