The Street Is Much Too Optimistic About Hospira
Stephen Simpson, CFA
Stephen Simpson, CFA
Nov. 5, 2014, 5:30 PM
- AAON, AAP, AAWW, AEE, AES, AINV, AKRX, AMCX, AMRC, AMSC, AOL, APA, AZN, BBG, BCE, BCRX, BDBD, BKCC, BR, CDW, CECE, CECO, CNK, CNQ, COTY, CPN, CRZO, CVC, CYNI, DNOW, DTV, ERJ, FSYS, FUN, FUR, GEO, GLP, GNRC, GOLD, HAIN, HII, HNR, HSC, HSIC, HSP, HZNP, IT, KATE, KERX, KLIC, LIN, LMIA, LPI, MITL, MPEL, MWIV, NAVB, NRF, NTWK, NXTM, ONE, OWW, PBH, PDCE, PERI, PHMD, PKD, PMC, PNK, POZN, PRFT, PRGO, PRIM, PTCT, RDNT, RGEN, SATS, SCMP, SFUN, SFY, SGM, SLH, SNI, SNMX, SRPT, TAP, TCPC, TDC, TEDU, THS, TK, TNDM, TPH, TU, VC, VIVO, WAC, WD, WEN, WIN, ZEUS
Nov. 1, 2014, 5:51 PM
- Hospira (NYSE:HSP) will report Q3 results on November 6 before the open. The conference call will begin at 8:00 am CT/9:00 am ET.
- Consensus view is EPS of $0.53 on revenues of $1.1B.
Oct. 21, 2014, 7:32 AM
- The Dermatologic and Ophthalmic Drugs Advisory Committee votes unanimously in favor of approving Novartis' (NYSE:NVS) interleukin-17A inhibitor secukinumab for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. A final decision by the FDA is expected in early 2015.
- Novartis has also submitted its regulatory application with the European Medicines Agency. A decision is expected in late 2014 to early 2015.
- Psoriasis-related tickers: (NYSE:JNJ) (NASDAQ:DERM) (NYSE:MRK) (NASDAQ:CELG) (NASDAQ:IDRA) (NYSE:HSP) (NYSEMKT:CANF) (NASDAQ:AMGN) (NYSE:AZN) (NYSE:PFE)
Oct. 16, 2014, 11:46 AM
- The Dermatologic and Ophthalmic Drugs Advisory Committee meets on Monday, October 20 to review Novartis' (NVS -1.7%) BLA for secukinumab, a human mAb, for the treatment of adults with moderate-to-sever plaque psoriasis who are candidates for systemic therapy or phototherapy.
- Briefing docs
- Psoriasis-related tickers: (JNJ -1%)(DERM -5%)(MRK -2.2%)(CELG -0.9%)(IDRA +6.8%)(HSP +1.1%)(CANF)(AMGN -1.5%)(AZN -1.1%)(PFE -1.3%)
Oct. 7, 2014, 9:54 AM
- Menlo Park, CA-based Virobay (VBAY) is set for its IPO of 3.8M shares at $12 - 14.
- The clinical stage biopharmaceutical firm develops drugs based on its cysteine cathepsin platform. Cysteine cathepsins are important enzymes in the biology of many diseases. The company believes that inhibiting these enzymes produces safer, more effective therapies. It currently focuses its efforts on inhibitors of cathepsins S and B.
- Its lead product candidates are cathepsin S inhibitors: VBY-036 for neuropathic pain and Crohn's disease and VBY-891 for psoriasis. Phase 2 development for all three indications should commence in 1H 2015 which means that meaningful product revenues are far in the distance.
- In 2013, the company generated $9.9M in collaboration revenue. Its operating loss was ($2.3M). In 1H 2015, collaboration revenue dropped to $1.1M and the loss from operations increased to ($3.6M).
- Crohn's disease-related tickers: (ABBV -1.6%)(MRK -1.2%)(RDHL +0.4%)(VBLX)(OTCPK:TKPHF)(OTCPK:TKPYY)(CNDO +1.1%)(OTCQB:SNGX)(PSTI +2.3%)
- Neuropathic pain-related tickers: (DARA -4.4%)(AVNR -3.4%)(ZLCS +0.9%)(IPCI -2%)(BLRX -1.9%)(MNOV +0.6%)(PFE -0.3%)(OTCPK:NGSX)
- Psoriasis-related tickers: (DERM -0.5%)(NVS -2.5%)(CELG -1.4%)(LLY -1.3%)(CANF -2.3%)(IDRA -1.4%)(JNJ -0.8%)(XNPT +0.5%)(HSP -0.2%)
Sep. 8, 2014, 1:33 PM
- The U.S. District Court for the District of Maryland rules that sales of generic versions of Hospira's (HSP -2.1%) proprietary sedative, Precedex (dexmedetomidine HCL injection), may proceed. The Court initially granted the company's motion for a temporary restraining order against the FDA, Mylan (MYL +2.1%) and Par Sterile Products against the introduction of generic formulations. Hospira has filed an appeal of the decision and a motion for injunction pending appeal before the U.S. Court of Appeals for the Fourth Circuit. Not known for waiting, Mylan restarts the launch of its generic version.
- Despite the adverse ruling, Hospira reaffirms its 2014 EPS guidance of $2.30 - 2.50.
- Precedex generated ~$440M in revenues in 2013. The company previously stated that the encroachment of generic Precedex competitors may force it to lay off sales personnel.
Aug. 20, 2014, 1:22 PM
- A federal judge issues a temporary restraining order against the FDA's decision to allow the sale of generic versions of Hospira's (HSP +1.4%) sedative Precedex (dexmedetomidine HCL injection) In its lawsuit filed yesterday, Hospira claims that the agency violated its own rules by allowing generic firms to launch competing products as long as the labeling omitted information about the drug's uses (intensive care unit sedation) covered by Hospira's patent.
- In his order, Judge Jarrod Hazel says that Hospira would likely win its suit because the FDA's decision as "at odds with relevant authority" and "tantamount to a change of the rules."
- Generic firm Sandoz (NVS +0.3%) intervened on Hospira's behalf because the ruling would deprive it of the six-month exclusivity it negotiated in its patent infringement settlement with Hospira in December.
- Related ticker: (MYL +2.8%)
Aug. 19, 2014, 4:12 PM
- After the FDA approved its ANDA yesterday, Mylan (MYL +1.3%) launches dexmedetomidine hydrochoride injection, 100 mcg (base)/mL, the therapeutic equivalent of Hospira's (HSP -2.8%) Precedex. The U.S. market is ~$156M.
- Mylan has 295 ANDAs pending FDA approval representing ~$105B in sales while 43 are potential first-to-file opportunities.
Jul. 30, 2014, 8:09 AM
- Hospira (NYSE:HSP) Q2 results: Net Sales: $1,135.8M (+10.7%); Operating Expenses: $1,036.3M (+6.4%); Operating Income: $99.5M (+90.6%); Net Income: $70.9M (+115.5%); EPS: $0.42 (+110.0%); CF Ops (6 mo.): $175.5M (+246.8%).
- 2014 Guidance: Net sales growth: 6 - 9%; non-GAAP EPS: $2.30 - 2.50 from $2.00 - 2.25; GAAP EPS: $1.09 - 1.29; CF Ops: $275M - 375M; CAPEX: $375M - 425M (unch).
Jul. 30, 2014, 7:39 AM
- Hospira (NYSE:HSP): Q2 EPS of $0.72 beats by $0.15.
- Revenue of $1.14B (+10.7% Y/Y) beats by $90M.
Jul. 27, 2014, 9:34 PM
- Hospira (NYSE:HSP) has emerged as a bidder for Danone's (OTCQX:DANOY) medical-nutrition unit in what could be about a $5B deal, reports the FT. A purchase could allow the Illinois-based Hospira to move its domicile abroad for tax purposes.
- Hospira's 25% rally YTD is a boon since to qualify for an inversion owners of the acquired company must receive at least 20% of the merged company's stock, meaning Hospira - currently valued at $8.6B - would have to fund a sizable portion of the deal with its shares.
- Previously, European consumer outfits like Nestle and Fresenius had been reported as prospective bidders for the Danone business, but it's unclear if either continues to have interest.
- Previously: Report: Danone looking to sell medical nutrition business to Nestle
Apr. 30, 2014, 7:33 AM
- Hospira (HSP): Q1 EPS of $0.60 beats by $0.11.
- Revenue of $1.05B (+6.2% Y/Y) beats by $30M.
Apr. 10, 2014, 3:17 PM
- London's High Court rules Roche's (RHHBY -0.7%) 115 and 455 Herceptin patents are invalid paving the way for Hospira (HSP -3.5%) to market a biosimilar version in Britain.
- Hospira wants to sell its offering of trastuzumab after Herceptin's core patent expires on July 28.
- Although Britain comprises a small part of Herceptin's $6.9B sales, Roche is carefully assessing its options in light of a possible domino effect in other European countries.
Apr. 10, 2014, 9:32 AM
- In its recent healthcare budget, French lawmakers introduced a measure that will allow pharmacists to substitute generics for prescribed brand-name biotech drugs. This has rattled the industry since France is Europe's #2 pharmaceutical market behind Germany.
- A decree must be passed before it becomes effective.
- France is the first European country to pursue biologic substitution. Big Pharma fears a domino effect if it is successful despite the heretofore slow uptake of biosimilars.
- The initiative applies only to patients starting a new course of treatment. Doctors will still retain the ability to demand the branded product.
- Unsurprisingly, Big Pharma is upset at not being consulted prior to the law's passage.
- Some analysts believe France could save up to $1.4B by 2020 by using generics.
- Substitutions only apply to retail pharmacies. 40% of biotech prescriptions are filled in hospitals.
- (RHHBY) (AMGN) (NVS) (SNY) (LLY) (PFE) (BMY) (MRK) (GSK) (JNJ) (HSP) (ABBV) (AZN) (BAYRY)
Apr. 1, 2014, 11:57 AM| Apr. 1, 2014, 11:57 AM
Feb. 12, 2014, 9:31 AM
- Hospira's (HSP) net profit soars to $33.5M from $5.3M a year earlier, with the company's bottom line benefiting from lower restructuring charges and write-downs.
- Revenue was hurt by the impact of the hold on shipping for most of Hospira's infusion devices, a drop in sales of cancer drug oncolytic docetaxel, and forex fluctuations.
- However, sales at Hospira's specialty injectable pharmaceuticals segment grew 5.2% to $732.7M.
- Hospira reaffirmed its 2014 guidance for EPS of $2-2.25 vs consensus of $2.15. The upper end is based on the far-from-certain scenario that the company's Precedex intravenous sedative won't face generic competition until nearer the end of the year. (PR)
Hospira Inc is aprovider of injectable drugs and infusion technologies. The Company's business segments areSpecialty Injectable Pharmaceuticals, Medication Management and Other Pharmaceuticals.
Industry: Drug Delivery & Accessories
Country: United States
Other News & PR