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United Therapeutics Corporation (UTHR)

- NASDAQ
  • Wed, Aug. 19, 4:29 PM
    • The FDA designates BioMarin Pharmaceutical's (NASDAQ:BMRN) drisapersen a treatment of a rare pediatric disease, in this case Duchenne muscular dystrophy. The agency's definition pertains to pediatric diseases affecting fewer than 200K Americans.
    • Under the Rare Pediatric Disease Priority Review Voucher program, a company that receives approval for such a drug is eligible to receive a voucher that can be redeemed to obtain priority review for a subsequent marketing application for a different product. The voucher may be sold or transferred an unlimited number of times. The vouchers are quite valuable. United Therapeutics (NASDAQ:UTHR) just sold one to AbbVie (NYSE:ABBV) for $350M.
    • Drisapersen is also designated an Orphan Drug and a Breakthrough Therapy to be reviewed under Fast Track and Priority Review protocols.
    • Orphan Drug status provides for a seven-year period of market exclusivity for the indication, if approved.
    • Previously: United Therapeutics sells Priority Review Voucher to AbbVie for $350M (Aug. 19)
    | Wed, Aug. 19, 4:29 PM | 6 Comments
  • Wed, Aug. 19, 7:17 AM
    • AbbVie (NYSE:ABBV) buys United Therapeutics' (NASDAQ:UTHR) Rare Pediatric Disease Priority Review Voucher (PPRV) for $350M in cash. United was awarded the voucher when the FDA cleared Unituxin (dinutuximab) for the treatment of neuroblastoma in March.
    • The main benefit of the voucher, which can be bought and sold an unlimited amount of times, is a six-month review clock. Also, the voucher owner only has to give the FDA a short 90-day notice of its intention to use it.
    | Wed, Aug. 19, 7:17 AM | 6 Comments
  • Tue, Jul. 28, 6:24 AM
    • United Therapeutics (UTHR -2.1%) Q2 results: Revenues: $347.2M (+7.6%); COGS: $16.1M (-58.4%); R&D Expense: $49.4M (+24.4%); SG&A: $110M (+61.8%); Operating Income: $171.7M (-2.6%); Net Income: $99.2M (-11.3%); EPS: $1.91 (-9.0%); Quick Assets: $556.2M.
    • No guidance given.
    | Tue, Jul. 28, 6:24 AM | Comment!
  • Tue, Jul. 28, 6:01 AM
    • United Therapeutics (NASDAQ:UTHR): Q2 EPS of $2.55 beats by $0.24.
    • Revenue of $347.16M (+7.5% Y/Y) misses by $13.25M.
    • Press Release
    | Tue, Jul. 28, 6:01 AM | Comment!
  • Wed, Jun. 24, 1:43 PM
    • Screen criteria: market cap >=$1B; average daily turnover >=400K shares; % change in mutual fund ownership (most recent qtr) >=0%; PEG ratio: <=1.0.
    • (EVHC -0.8%)(ESRX -0.3%)(GILD -0.2%)(JAZZ -1.3%)(KANG -1.5%)(MOH -0.4%)(MYL -0.3%)(SHPG -1%)(UTHR -3.6%)(VRX -1.4%)(ZTS -1.2%)
    • This is not a list of Buy/Sell recommendations, but rather a targeted list of stocks that may be suitable for more in-depth research.
    | Wed, Jun. 24, 1:43 PM | 13 Comments
  • Wed, May 20, 5:41 PM
    | Wed, May 20, 5:41 PM | 3 Comments
  • Tue, Apr. 28, 7:31 AM
    • United Therapeutics (NASDAQ:UTHR) Q1 results ($M): Total Revenues: 327.5 (+26.3%); Product Sales: 325.9 (+14.5%); Operating Expenses: 321.5 (+645.9%); Net Income: (16.6) (-112.1%); EPS: (0.36) (-114.8%); Non-GAAP EPS: 2.55 (+36.4%).
    • Sales by Product: Remodulin: 146.3 (+7.5%); Tyvaso: 113.4 (+5.9%); Adcirca: 45.4 (+9.7%); Orenitram: 20.9.
    • No guidance provided in press release.
    | Tue, Apr. 28, 7:31 AM | Comment!
  • Tue, Apr. 28, 6:03 AM
    • United Therapeutics (NASDAQ:UTHR): Q1 EPS of $2.55 beats by $0.41.
    • Revenue of $327.5M (+13.2% Y/Y) misses by $26M.
    • Press Release
    | Tue, Apr. 28, 6:03 AM | Comment!
  • Mon, Apr. 27, 4:38 PM
    • United Therapeutics (NASDAQ:UTHR) will report Q1 results tomorrow before the open. Consensus view is EPS of $2.14 on revenues of $353.5M.
    | Mon, Apr. 27, 4:38 PM | Comment!
  • Tue, Mar. 10, 12:34 PM
    • The FDA approves United Therapeutics' (UTHR +0.4%) Unituxin (dinutuximab) injection, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line therapy.
    • Neuroblastoma is the most common extracranial solid cancer in children and the most common cancer in infancy, affecting ~700 patients each year. About half are diagnosed as high-risk.
    • Unituxin, a maintenance therapy for neuroblastoma, is a chimeric biologic antibody that induces cell lysis (breakdown) of GD2-expressing cells. GD2 is an attractive target for cancer immunotherapies since it is strongly expressed in tumors of neuroectodermal origin while highly restricted on normal cells.
    | Tue, Mar. 10, 12:34 PM | 1 Comment
  • Mon, Mar. 9, 5:21 PM
    • Rehovot, Israel-based SteadyMed  (Pending:STDY) is set for its IPO of 4.25M shares of common stock at $12 - 14. Underwriters over-allotment is an additional 637.5K shares.
    • The specialty pharmaceutical company focuses on the development and commercialization of therapeutics that address the limitations of market-leading products in certain orphan and other well-defined, high-margin specialty markets. Its lead product candidate is Trevyent, a small, pre-filled, single-use device that delivers parenteral treprostinil (Remodulin) at a pre-programmed rate to patients with pulmonary arterial hypertension. Its value proposition is a more convenient dosing regimen enabled by its PatchPump technology which delivers a steady flow of drug to the patient either intravenously or subcutaneously.
    • The company intends to apply for Orphan Drug designation with the FDA by mid-year and submit an New Drug Application (NDA) by Q1 2016.
    • Net losses for 2014, 2013 and 2012 were ($19.0M), ($7.9M) and ($4.1M), respectively. Operations consumed $13.4M in cash in 2014 and $7.5M in 2013.
    • Related ticker: (NASDAQ:UTHR)
    | Mon, Mar. 9, 5:21 PM | Comment!
  • Thu, Mar. 5, 8:52 AM
    • AbbVie's (NYSE:ABBV) extraordinarily generous buyout of Pharmacyclics (NASDAQ:PCYC) is a crystal clear example of how keen big pharma is to boost its prospects with biotech drugs with blockbuster potential. The transaction's $20B tab, backing out PCYC's $1B cash balance, values Imbruvica (ibrutinib) at $40B since Pharmacyclics' commercial partner Johnson & Johnson (NYSE:JNJ) gets 50% of Imbruvica's revenue. This implies a multiple of almost 7x Imbruvica's projected peak sales of $6B. By comparison, Amgen's (NASDAQ:AMGN) takeout of Onyx Pharma and Sanofi's (NYSE:SNY) takeout of Genzyme were both at 5x premiums.
    • The looming patent expiration for Humira ($12.5B in sales the past four quarters) undoubtedly provided AbbVie extra incentive to get the deal done.
    • Adding 50% of Imbruvica's sales to AbbVie's top line should increase its revenue growth 3 - 7% and EPS growth 8 - 11% through 2020.
    • According to RBC analyst Michael Yee, other biotechs on the big ticket acquisition radar are: BioMarin Pharmaceuticals (NASDAQ:BMRN), Dyax (NASDAQ:DYAX), Esperion Therapeutics (NASDAQ:ESPR), United Therapeutics (NASDAQ:UTHR), Vertex Pharmaceuticals (NASDAQ:VRTX), Intercept Pharmaceuticals (NASDAQ:ICPT), Juno Therapeutics (NASDAQ:JUNO), Kite Pharma (NASDAQ:KITE), PTC Therapeutics (NASDAQ:PTCT) and Receptos (NASDAQ:RCPT).
    | Thu, Mar. 5, 8:52 AM | 5 Comments
  • Tue, Feb. 24, 1:37 PM
    • United Therapeutics (NASDAQ:UTHR+0.1%Q4 results ($M): Revenues: 346.4 (+19.9%); Operating Expenses: 152.0 (-45.5%); Operating Income: 178.6 (+726.7%); Net Income: 115.9 (+482.5%); EPS: 2.17 (+461.7%).
    • Key product sales: Remodulin: 136.6 (+13.9%); Tyvaso: 115.1 (+0.6%); Adcirca: 73.5 (+41.3%).
    | Tue, Feb. 24, 1:37 PM | Comment!
  • Tue, Feb. 24, 6:01 AM
    • United Therapeutics (NASDAQ:UTHR): Q4 EPS of $3.21 beats by $1.18.
    • Revenue of $346.36M (+19.8% Y/Y) beats by $10.14M.
    • Press Release
    | Tue, Feb. 24, 6:01 AM | Comment!
  • Mon, Feb. 23, 5:30 PM
  • Mon, Feb. 9, 12:21 PM
    • The following are healthcare companies whose after-tax margins have expanded the past three quarters and trade at least 500K shares per day:
    • (ACOR -0.7%)(BCR -1.5%)(BIIB -0.2%)(CAH -1.2%)(CPHD +1.3%)(EVHC -1.6%)(ILMN +0.7%)(JAZZ -1.7%)(LCI +7.3%)(MNK -0.5%)(SHPG -2.9%)(SYK -0.2%)(TMO -0.7%)(UTHR +1.4%)(VRX).
    • This is not a list of "Buy" recommendations, but rather a targeted list of firms that may be suitable for more in-depth research.
    | Mon, Feb. 9, 12:21 PM | 3 Comments
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Company Description
United Therapeutics Corp is a biotechnology company. The Company is engaged in thedevelopment and commercialization of products to address the unmet medical needs of patients with chronic and life-threatening conditions.