Ulta (Nasdaq: ULTA ) reported earnings on June 11. Here are the numbers you need to know.
The 10-second takeaway
For the quarter ended May 4 (Q1), Ulta beat slightly on revenues and beat expectations on earnings per share.
Compared to the prior-year quarter, revenue expanded significantly. GAAP earnings per share expanded significantly.
Margins shrank across the board.
Ulta reported revenue of $582.7 million. The 12 analysts polled by S&P Capital IQ hoped for a top line of $576.3 million on the same basis. GAAP reported sales were 23% higher than the prior-year quarter’s $474.1 million.
Source: S&P Capital IQ. Quarterly periods. Dollar amounts in millions. Non-GAAP figures may vary to maintain comparability with estimates.
EPS came in at $0.65. The 12 earnings estimates compiled by S&P Capital IQ predicted $0.62 per share. GAAP EPS of $0.65 for Q1 were 20% higher than the prior-year quarter’s $0.54 per share.
Top 5 Biotech Stocks To Buy For 2015: Genomic Health Inc (GHDX)
Genomic Health, Inc. (Genomic Health), incorporated in August 2000, is a molecular diagnostics company focused on the global development and commercialization of genomic-based clinical laboratory services that analyze the underlying biology of cancer allowing physicians and patients to make individualized treatment decisions. Its Oncotype DX platform utilizes quantitative genomic analysis known as reverse transcription polymerase chain reaction (RT-PCR), in standard tumor pathology specimens to provide tumor-specific information, or the oncotype of a tumor. As of February 2012, Oncotype DX was evaluated in invasive breast cancer in 13 clinical studies involving more than 4,000 breast cancer patients worldwide. Genomic Health offers its Oncotype DX tests as a clinical service, where it analyzes the expression levels of genes in tumor tissue samples and provide physicians with a quantitative gene expression profile expressed as a single quantitative score, which it calls a R ecurrence Score, for invasive breast cancer and colon cancer and a DCIS Score for DCIS. Its Oncotype DX breast cancer test analyzes the expression levels of 21 genes and Oncotype DX colon cancer test analyzes the expression levels of 12 genes. In March 2012, the Company established a wholly owned subsidiary, InVitae Corporation.
Oncotype DX Platform
The Company’s Oncotype DX platform uses its RT-PCR approach to improve cancer treatment decisions. Its diagnostic approach correlates gene expression to clinical outcomes and provides an individualized analysis of each patient’s tumor. The Company has built a diagnostic infrastructure that allows it to move from research into development through to processing actual patient samples in its clinical reference laboratory. The Company offers Oncotype DX tests as clinical laboratory services. Its technology allows the Company to analyze tumor tissue samples in its clinical reference laboratory and provide physicians with genomic information specific to the patient’! s tumor. It analyzes tissues that are handled, processed and stored under routine clinical pathology laboratory practices.
Oncotype DX Breast Cancer Test
To develop its Oncotype DX breast cancer test, the Company evaluated 250 genes in three independent clinical studies, which identified a 21-gene panel whose composite gene expression profile can be represented by a breast cancer Recurrence Score. The Company conducted studies of its Oncotype DX breast cancer test with clinical samples from postmenopausal women with invasive breast cancer who were treated with aromatase inhibitors. In March 2010, the Journal of Clinical Oncology published results from a European study using its test to analyze tumor samples from over 1,200 patients in the ATAC (Arimedix, Tamoxifen, Alone or in Combination) trial, which established the use of aromatase inhibitors for adjuvant treatment of postmenopausal women with hormone receptor-positive breast cancer. The study demonstrated that, along with other standard measures, such as tumor size, its Oncotype DX breast cancer test contributes independently to provide a more complete picture of prognosis for N- and N+ patients treated with aromatase inhibitors.
In December 2011, the Company presented positive results from the ECOG E5194 DCIS clinical validation study at SABCS. The study met its primary endpoint by demonstrating that a pre-specified Oncotype DX DCIS Score can predict the risk of local recurrence, defined as either the development of a new invasive breast cancer or the recurrence of DCIS in the same breast. In December 2011, the Company made Oncotype DX available for patients with ductal carcinoma in situ (DCIS), of the breast, a pre-invasive form of breast cancer. The launch of Oncotype DX for DCIS patients was based on positive results presented from a clinical validation study of Oncotype DX breast cancer test in patients with DCIS, conducted by the Eastern Coop erative Oncology Group (ECOG), a clinical trials cooperative! group su! pported by the National Cancer Institute.
Oncotype DX Colon Cancer Test
The Company developed its gene panel by identifying 761 cancer-related genes through review of existing research literature and computer analysis of genomic databases. The 761 candidate genes were also examined to determine whether they would be useful beyond other key variables including tumor stage, tumor grade, lymph nodes examined and MMR/MSI. It selected a final set of 12 genes, which were then independently evaluated in a validation study of over 1,400 stage II colon cancer patients from the Quick and Simple and Reliable (QUASAR), randomized study of adjuvant chemotherapy in the United Kingdom. This international, multi-center randomized trial examined the recurrence risk and the benefit associated with 5-fluorouracil/leucovorin, or 5FU/LV, adjuvant chemotherapy. Gene expression was quantified by RT-PCR from manually microdissected FPE primary colon cancer tissue, and rec urrence-free interval, disease-free survival and overall survival were analyzed. In January 2012, the Company presented positive results of the first clinical decision making study of the Oncotype DX colon cancer test that shows that Recurrence Score result has a significant impact on treatment recommendations for stage II colon cancer patients.
The Company competes with General Electric Company, Hologic, Inc., Novartis AG, Myriad Genetics, Inc., Qiagen N.V., Response Genetics, Inc., Laboratory Corporation of America Holdings, Quest Diagnostics Incorporated, Roche Holding, Ltd, Siemens AG and Johnson & Johnson.
- [By John Udovich]
On Tuesday, small cap cancer diagnostic stock Myriad Genetics, Inc (NASDAQ: MYGN) jumped 11.42% in one day, meaning its worth taking a closer look at the stock along with the performance of small cap cancer diagnostic stocks like Rosetta Genomics Ltd (NASDAQ: ROSG) and Genomic Health, Inc (NASDAQ: GHDX) plus mid cap diagnostic stock Quest Diagnostics Inc (NYSE: DGX). I should mention that we have had Myriad Genetics in our SmallCap Network Elite Opportunity (SCN EO) portfolio since February 5th and we are already up 18.50% – a nice return in just two weeks time.
- [By John Udovich]
Large and small cap cancer stocks Gilead Sciences, Inc (NASDAQ: GILD), Celgene Corporation (NASDAQ: CELG), Veracyte (NASDAQ: VCYT), Genomic Health, Inc (NASDAQ: GHDX), Cell Therapeutics Inc (NASDAQ: CTIC) and MetaStat Inc (OTCMKTS: MTST) have all been producing a steady stream of news lately for biotech investors looking for a way to cash in on the growth in development of cancer treatments. Just consider the following news:
- [By Sean Williams]
What: Shares of Genomic Health (NASDAQ: GHDX ) , a provider of genome-based clinical diagnostic tests, popped as much as 10% following the release of its first-quarter results.
- [By Keith Speights]
Genetic testing stands out as one current example of how scientific advances can help reduce medical costs. Genomic Health (NASDAQ: GHDX ) makes genetic diagnostic tests for breast, colon, and prostate cancer. Half of the patients diagnosed with prostate cancer each year actually have a very low risk of the cancer progressing. However, 90% of these low-risk patients still undergo surgery or radiation — at a cost of tens of thousands of dollars per patient. Genomic Health’s genetic test helps identify which patients really need more extensive treatment and holds the potential to reduce overall costs.
Top 5 Biotech Stocks To Buy For 2015: Cytomedix Inc (CMXI)
Cytomedix, Inc. (Cytomedix), incorporated in April 29, 1998, is a regenerative therapies company marketing and developing products within the United States and internationally .The Company commercializes cell-based technologies that harness the regenerative capacity of the human body to trigger natural healing. The Company is a commercial operation, and a robust clinical pipeline representing a logical extension of its commercial technologies in the evolving field of regenerative medicine. Cytomedix primarily operates in the United States. Its commercial offerings are centered on its point of care platform technologies for the safe and efficient separation of blood and bone marrow to produce platelet based therapies or cell concentrates.
The Company markets and selsl two distinct platelet rich plasma (PRP) technologies, the AutoloGel System for wound care and the Angel concentrated Platelet Rich Plasma (cPRP) Sytem in orthopedic and cardiovascular markets. It s clinical pipeline includes the ALDH, which are cell-based therapies (Bright Cells). In February 2012, the Company acquired Aldagen, Inc.
The AutoloGel System
The AutoloGel System is a point of care device for the production of a platelet based bioactive therapy derived from a small sample of the patient’s own blood. Using the patient’s own platelets as a therapeutic agent, AutoloGel harnesses the body’s natural healing processes to deliver growth factors, chemokines and cytokines known to promote angiogenesis and to regulate cell growth and the formation of new tissue.
Angel Product Line
The Angel concentrated Platelet Rich Plasma (cPRP) System is a multi-functional cell separation device which produces concentrated platelet rich plasma for use in the operating room and clinic and is used in a range of orthopedic and cardiovascular indications. Similar to the AutoloGel System, the Angel System is a point of care d evice for the production of a concentrated, aseptic platelet! -based bioactive therapy derived from a small sample of the patient’s own blood. The resulting cPRP is applied at the site of injury to promote healing. The Angel product line also includes ancillary products such as phlebotomy and applicator supplies and activAT. activAT is designed to produce autologous thrombin serum from platelet poor plasma and is sold exclusively in Europe and Canada, where it provides a safe alternative to bovine-derived products.
ALDHbr Cell Technology and Development Pipeline
The ALDHbr (Bright Cell) technology is an approach to cell-based regenerative medicine and a logical extension of its commercial technologies in the evolving regenerative medicine market, with potential clinical indications in markets with unmet medical needs such as peripheral arterial disease and ischemic stroke. The Bright Cell technology is in that it utilizes an intracellular enzyme marker to facilitate fractionation of essential regenerative cells from a patient’s bone marrow. The bone marrow fractionation process identifies and isolates active stem and progenitor cells expressing high levels of the enzyme aldehyde dehydrogenase, or ALDH, which is a key enzyme involved in the regulation of gene activities associated with cell proliferation and differentiation.
The Company’s lead product candidate, ALD-401, is an autologous preparation of Bright Cells for the post-acute treatment of ischemic stroke. ALD-401 is being evaluated in the RECOVER-Stroke clinical study, an ongoing 100-patient, double-blind, placebo-controlled Phase 2 study in patients with unilateral, cerebral ischemic stroke with an NIH stroke scale score of less than 22. An additional product candidate, ALD-301, is in clinical development for peripheral arterial disease (PAD), a condition causing reduced flow of blood and oxygen to muscles in the leg. It has completed a Phase 1/2 study of autologous ALD-301 in critical limb ischemia ( CLI), a late stage condition caused by PAD. The Phase 2 PACE! (Patient! s with Intermittent Claudication Injected with ALDH Bright Cells) study is an 80 patient, double-blind, placebo-controlled clinical trial intended to demonstrate the safety and efficacy of ALD-301 (Bright Cells) in patients diagnosed with IC.
The Company competes with Harvest Technologies (a subsidiary of Terumo), Biomet, Arteriocyte, and Arthrex.
- [By James E. Brumley]
To give credit where it’s due, Cytomedix, Inc. (OTCBB:CMXI) and Baxter International Inc. (NYSE:BAX) have both helped shape the landscape of the hemostasis (bleeding control) market with their products, AutoloGel and TISSELL, respectively. Arch Therapeutics Inc. (OTCBB:ARTH) has proverbially taken their concepts “up a notch”, however, and its direct solution to a problem that CMXI and BAX can’t quite solve may make ARTH the hottest trading candidate in the hemostasis space.
- [By Bryan Murphy]
When traders think of post-surgical wound management stocks, they may first think of names like Cytomedix, Inc. (OTCBB:CMXI) or Alliqua Inc. (OTCMKTS:ALQA). And well they should. Both companies have something of a history in the arena. ALQA is the purveyor of SilverSeal and Hydress antibiotic bandages, while CMXI is the developer of the AutoloGel system, which induces an affected patient’s on body to do what it’s supposed to do if there’s a wound that won’t heal. Cytomedix also makes the Angel platelet-rich plasma (PRP) delivery system. There’s a relatively new name to add to the list of game-changing stocks in wound-management industry, however…. Arch Therapeutics Inc. (OTCBB:ARTH). The company is developing – well, has developed – a product called AC5 that nips post-surgical bleeding in the bud, largely negating the need for other post-surgical bleeding-control measures.
Top 5 Biotech Stocks To Buy For 2015: Tekmira Pharmaceuticals Corp (TKMR)
Tekmira Pharmaceuticals Corporation is a biopharmaceutical company focused on advancing ribonucleic acid (RNA) interference (RNAi) therapeutics and providing its lipid nanoparticle (LNP) delivery technology to pharmaceutical partners. On March 1, 2012, it announced that the Company had secured a license from Alnylam to develop TKMALDH2, an RNAi therapeutic that utilizes Tekmira’s LNP for the treatment of Alcohol Dependence (AD). Its lead oncology product candidate, TKM-PLK1, targets PLK1, a protein involved in tumor cell proliferation and a validated oncology target. On February 8, 2012, it announced that Phase I clinical trial for TKM-Ebola had been initiated. The Phase 1 TKM-Ebola clinical trial is a placebo-controlled, single-blind, single-ascending dose study with additional multiple-ascending dose cohorts in healthy human volunteers. In the field of RNAi therapeutics, the Company has licensed its LNP delivery technology to Alnylam Pharmaceuticals, Inc. and Merck & Co., I nc. Advisors’ Opinion:
- [By Lisa Levin]
Tekmira Pharmaceuticals (NASDAQ: TKMR) shares climbed 34.11% to $13.25. The volume of Tekmira Pharmaceuticals shares traded was 2187% higher than normal. Tekmira signed a development agreement with Monsanto (NYSE: MON) on delivery technology for agricultural applications.
- [By Markus Aarnio]
Companies working on chemically synthesized siRNAs include Merck (MRK), through its subsidiary Sirna Therapeutics, Inc., Novartis (NVS), Takeda (TKPHF.PK), Kyowa Hakko Kirin, Marina Biotech, Inc., Arrowhead and its subsidiary, Calando, Quark, Silence Therapeutics plc, Tekmira (TKMR), Sylentis and Dicerna Pharmaceuticals, Inc.
Top 5 Biotech Stocks To Buy For 2015: Pain Therapeutics Inc (PTIE)
Pain Therapeutics, Inc., incorporated in May 1998, is a biopharmaceutical company that develops drugs. The Company has four drug candidates in clinical programs, including REMOXY, abuse-resistant hydromorphone, abuse-resistant hydrocodone and a radio-labeled monoclonal antibody to treat metastatic melanoma. It is also working on a new treatment for patients with hemophilia. The Company’s lead drug candidate is REMOXY, which is a painkiller. It has collaboration agreement with King Pharmaceuticals, Inc (King) develops and commercializes REMOXY and other opioid painkillers. The Company and King jointly managed a Phase III clinical program and New Drug Application (NDA) submission for REMOXY. It is also developing a pipeline of drug candidates in the area of oncology and hematology. It owns all commercial rights to its pipeline of drug candidates in oncology and hematology. As of December 31, 2010, the Company leased approximately 30,700 square feet of space in San Mateo, California and all of its operations are located in San Mateo.
REMOXY is a controlled-release oral capsule form of oxycodone in a highly viscous liquid formulation matrix that includes excipients. It is formulated to help address issues of abuse and misuse of time-release oxycodone tablets. REMOXY’s capsule dosage form provides therapeutic drug levels of oxycodone on a twice-daily dosing schedule, while resisting the rapid increases in plasma levels of oxycodone associated with common methods of abuse and misuse. Its formulation also resists delivery by unapproved routes of administration, such as injection, snorting or inhalation.
The Company is developing a drug candidate called PTI-188 to treat metastatic melanoma, a form of skin cancer. PTI-188 is a monoclonal antibody linked to a radioisotope, intended to deliver doses of radiation lethal to melanoma tumors without harming normal tissue. I n March 2010, the Company announced data from two open-label! , dose-escalating Phase I studies conducted in Israel to assess the safety, pharmacokinetics, dosimetry and anti-tumor activity of PTI-188. During the year ended December 31, 2010, the second study was completed. The technology used in this program was developed at the Albert Einstein College of Medicine (AECOM). It had licensed worldwide commercial rights to this technology from AECOM.
The Company has a gene transfer program, initially developed at Stanford University, focused at correcting a genetic disorder in which patients are unable to stop bleeding. During 2010, it conducted a variety of pre-clinical studies with this technology. The Company has licensed worldwide commercial rights to the technology used in this program from Poetic Genetics, LLC (Poetic).
Other product candidates
The Company’s alliance with King includes development of three other abuse-resistant opioid product candidates: hydromorphone , hydrocodone and oxymorphone. Its abuse-resistant formulations of hydromorphone and hydrocodone have completed Phase I clinical trials. In January 2011, the Company announced that the Food and Drug Administration (FDA) had accepted its investigational IND, for abuse-resistant oxymorphone.
The Company competes with Roxane Laboratories, Purdue Pharma, King Pharmaceuticals, Inc., Abbott Laboratories, Cephalon, Endo Pharmaceuticals, Teva Pharmaceuticals, Elkins-Sinn, Watson Laboratories, Ortho-McNeil Pharmaceutical and Forest Pharmaceuticals.
- [By Sean Williams]
However, all isn’t well when it comes to the future of abuse-resistant painkiller Remoxy, which was developed by Pain Therapeutics (NASDAQ: PTIE ) , using Durect’s special technology-based gel capsule to prevent abuse, and is licensed by Pfizer (NYSE: PFE ) . Remoxy has been rejected twice by the FDA — the most recent coming in mid-2011 — and Pfizer commented this morning that if it were to seek reapproval for the drug it wouldn’t be for at least two more years. Given Pfizer’s extensive product pipeline, losing Remoxy wouldn’t be a big deal. For micro-cap clinical-stage companies like Pain Therapeutics and Durect, it’d be a gigantic blow. Fittingly, Pain Therapeutics and Durect shares imploded by 50% and 34%, respectively, on Friday.
- [By Jessica Alling]
Elsewhere, Pfizer is evaluating its continued partnership on an experimental oxycodone capsule, Remoxy. The drug is an extended-release formula that is targeted at reducing abuse of the painkiller. After years of setbacks and postponements for FDA approval, Pfizer is weighing its options. Its partners for the drug, Pain Therapeutics (NASDAQ: PTIE ) and Durect, have both fallen heavily due to the news, with Pain Therapeutics falling more than 50% — its largest decline ever.
Top 5 Biotech Stocks To Buy For 2015: Mast Therapeutics Inc (MSTX)
Mast Therapeutics, Inc., formerly ADVENTRX Pharmaceuticals, Inc., incorporated in December 1995, is a development-stage company biopharmaceutical company focused on developing product candidates. The Company’s product candidate is ANX-188, a rheologic, antithrombotic and cytoprotective agent that improves microvascular blood flow and has application in treating a range of diseases and conditions, such as complications arising from sickle cell disease. As of December 31, 2011, the Company also is developing ANX-514, a detergent-free formulation of the chemotherapy drug docetaxel. The Company offers ANX-188 (purified poloxamer 188), ANX-514 (docetaxel for injectable emulsion) and Exelbine (vinorelbine injectable emulsion). In April 2011, the Company acquired SynthRx, Inc. In February 2014, Mast Therapeutics Inc completed its acquisition of Aires Pharmaceuticals, Inc. Aires became a wholly-owned subsidiary of Mast Therapeutics.
ANX-188 (purified poloxamer 188)
ANX-188 is an aqueous solution of a purified form of poloxamer 188. Poloxamer 188 (P1880, is a nonionic, block copolymer that has been found to improve microvascular blood flow by reducing viscosity, particularly under low shear conditions, and by reducing adhesive frictional forces. The Company’s purified form of P188 (purified P188), which is the active ingredient in ANX-188, was designed to eliminate certain low molecular weight substances present in P188 (non-purified), which is primarily responsible for the moderate to moderately severe elevations in serum creatinine levels (acute renal dysfunction) observed in prior clinical studies of P188 (non-purified). Purified P188 has been evaluated in multiple clinical studies by a prior sponsor, including a 255-patient, phase III study.
ANX-514 (docetaxel for injectable emulsion)
ANX-514 is a detergent-free emulsion formulation of docetaxel, an intravenously-injected chemotherapy drug c ommonly used to treat solid tumors. Taxotere, a branded form! ulation of docetaxel, is approved to treat breast, non-small cell lung, prostate, gastric, and head and neck cancers. ANX-514 was designed to have clinically comparable release of docetaxel relative to Taxotere while eliminating the presence of polysorbate 80 and ethanol, both of which are used to solubilize docetaxel in the Taxotere formulation. The ANX-514 formulation solubilizes docetaxel using oil droplets consists of a combination of non-toxic excipients. Docetaxel is contained within these oil droplets and can be administered intravenously without using detergents as pharmaceutical vehicles. Once in central circulation, the emulsion is metabolized rapidly, leaving chemically-identical active ingredient to exert its cytotoxic effect. ANX-514 may reduce the incidence and severity of hypersensitivity reactions and delay the onset of fluid retention.
Exelbine (vinorelbine injectable emulsion)
Exelbine is an emulsion formulation of the chemother apy drug vinorelbine. Navelbine, a branded formulation of vinorelbine, is approved in the United States to treat advanced non-small cell lung cancer as a single agent or in combination with cisplatin, and approved in the European Union to treat non-small cell lung cancer and advanced or metastatic breast cancer.
In August 2011, the Company received a complete response letter from the Food and Drug Administration (FDA) stating that it could not approve the Exelbine Non Disclosure Agreement (NDA) in its present form and that the bioequivalence study would need to be repeated because the authenticity of the drug products used in the bioequivalence trial could not be verified in accordance with FDA standards. However, the Company elected to discontinue independent development of Exelbine and as of December 31, 2011, the Company was seeking a partner or outside investor for the program to complete the necessary bioequivalence study.
The Company compete s with GlaxoSmithKline, Provenge and Pfizer.
- [By John Udovich]
The start of 2014 shows that biotech is still a hot area with the sector along with small cap biotech stocks like AMAG Pharmaceuticals, Inc (NASDAQ: AMAG), Mast Therapeutics Inc (NYSEMKT: MSTX), Cell Therapeutics Inc (NASDAQ: CTIC), Imprimis Pharmaceuticals Inc (NASDAQ: IMMY) and TNI BioTech (OTCMKTS: TNIB) producing news or returns plus Auspex Pharmaceuticals (NASDAQ: ASPX), Cara Therapeutics (NASDAQ: CARA), Egalet (NASDAQ: EGLT), Flexion Therapeutics (NASDAQ: FLXN) and Ultragenyx Pharmaceutical (NASDAQ: RARE) are among the (many…) planned biotech IPOs that have recently been announced publicly:
- [By Lauren Pollock]
Mast Therapeutics Inc.(MSTX) said the U.S. Food and Drug Administration gave orphan-drug designation to its MST-188 drug for the treatment of acute limb ischemia, providing a boost for the biopharmaceutical firm. Shares surged.
- [By James E. Brumley]
A little over a month ago, owning Mast Therapeutics, Inc. (NYSE: MSTX) was nothing but pure misery. Shares plunged from $0.63 to $0.43 in one day, when details of a dilutive public offering were unveiled. As is so often the case though, the market may have overshot with the selling effort that KO’s MSTX. Though putting more shares ‘out there’ mathematically meant existing shareholders would have to share more of the company’s upside with newcomers, what’s slowly coming to light is that the inflow of new cash is still more advantageous to those prior shareholders; the company would progress little without it.