St. Jude Medical Inc. (STJ) is set to report its second-quarter 2013 results before the opening bell on Wednesday, Jul 17. Let's see how things are shaping up prior to the announcement.
In the last reported quarter, the medical device major posted break-even earnings surprise. An improved operating margin on the back of the company�� restructuring efforts to streamline the underlying business helped offset declining organic revenue growth.
Factors to Consider This Quarter
We are primarily concerned about St. Jude�� declining top line. The core Cardiac Rhythm Management (CRM) division continues to face multiple headwinds. A still choppy U.S. defibrillator market remains an overhang on St. Jude, as reflected by sustained implant volume pressure. Additionally, we remain cautious about increased competition, pricing pressure, softness in cardiovascular sales along with currency fluctuations.
Meanwhile, we expect growth in international revenues to boost overall sales of the company. New growth drivers such as an innovative product line along with restructuring efforts to streamline the underlying business will likely be accretive for STJ in the long term. The company has received a number of regulatory approvals for its latest offerings as well as initiated a number of clinical trials in the second quarter, which is encouraging.
Best Medical Companies For 2014: Hanger Orthopedic Group Inc.(HGR)
Hanger Orthopedic Group, Inc. engages in the ownership and operation of orthotic and prosthetic (O&P) patient care centers in the United States. The company provides orthotic and prosthetic patient care services. Its orthotics business include the design, fabrication, fitting, and maintenance of a range of standard and custom-made braces and other devices that provide external support to patients suffering from musculoskeletal disorders, such as ailments of the back, extremities or joints, and injuries from sports or other activities. The company?s prosthetics business comprise designing, fabricating, fitting, and maintaining custom-made artificial limbs for patients, who are without limbs as a result of traumatic injuries, vascular diseases, diabetes, cancer, or congenital disorders. It also distributes branded and private label O&P devices, as well as develops programs to manage various aspects of O&P patient care for insurance companies. In addition, the company manufac tures and distributes therapeutic footwear for diabetic patients in the podiatric market, as well as develops and provides specialized rehabilitation technologies and integrated clinical programs to rehabilitation providers. As of June 30, 2011, it operated approximately 675 patient-care centers in 45 states and the District of Columbia. The company, formerly known as Sequel Corporation, was founded in 1861 and is headquartered in Austin, Texas.
Best Medical Companies For 2014: Non-Invasive Monitoring Systems Inc (NIMU)
Non-Invasive Monitoring Systems, Inc. (NIMS), incorporated on July 16, 1980, along with its subsidiaries, is engaged in the research, development, manufacturing and marketing of a line of motorized, non-invasive, whole body, periodic acceleration platforms, which are intended as aids to increase local circulation and temporary relief of minor aches and pains, produce local muscle relaxation and reduce morning stiffness. The Company�� products are derivatives of its original acceleration platform, the AT-101, and are for use in homes, wellness centers and clinics. NIMS is focused on developing and marketing its Exer-Rest line of acceleration therapeutic platforms based upon whole body periodic acceleration (WBPA) technology. The Exer-Rest line of acceleration therapeutic platforms includes the Exer-Rest AT, AT3800 and AT4700 models. In addition, it receives royalty revenue from the sales of non-invasive diagnostic monitoring devices and related software.
Whole Body Periodic Acceleration (WBPA) Therapeutic Devices
The AT-101 is a device that moves a platform repetitively in a head-to-foot motion at a rapid pace. In January 2005, the Company ceased manufacturing the AT-101. The Exer-Rest AT therapeutic vibrator is based upon the design and concept of the AT-101 therapeutic vibrator, but has the dimensions and appearance of a commercial extra long twin bed. The Exer-Rest AT was manufactured by QTM Incorporated (QTM). The wired hand held controller provides digital values of speed, travel and time rather than analog values of speed and arbitrary force values as in the AT-101. the Company discontinued manufacturing of the Exer-Rest AT in July 2009. The Exer-Rest SL and Exer-Rest TL, which were manufactured by Sing Lin Technology Co., Ltd. (Sing Lin), are next generation versions of the Exer-Rest AT and advance the acceleration therapeutic platform technology.
LifeShirt
The LifeShirt is a wearable physiological computer that incorporates transducers, ele! ctrodes and sensors into a sleeveless garment. Pulse oximetry is an optional add-on. These sensors transmit vital and physiological signs to a miniaturized, battery-powered, electronic module which saves the raw waveforms and digital data to the compact flash memory of a Personal Digital Assistant (PDA) attached to the LifeShirt. Users of the LifeShirt can enter symptoms (with intensity), mood and medication information directly into the PDA for integration with the physiologic information collected by the LifeShirt garment. Such data are then transmitted from the flash memory to a data collection center that transforms the data into minute-by-minute median trends of over 30 physical and emotional signs of health and disease. In addition, the monitored patient can enter symptoms with intensity, mood, and medication directly into the PDA for integration with the physiologic information collected with the LifeShirt garment. As of July 31, 2009, LifeShirt was not marketed. The LifeShirt was sold by VivoMetrics, but has not been marketed since VivoMetrics ceased operations in July 2009.
The Company competes with Power Plate of North America, Vibraflex and CERAGEM International, Inc.
RXi Pharmaceuticals Corporation (RXi), incorporated on September 8, 2011, is a development-stage company. The Company is a biotechnology company focused on discovering, developing and commercializing therapies addressing medical needs using RNA interference (RNAi)-targeted technologies. As of July 12, 2012, RXi was focusing on its internal therapeutic development efforts in fibrosis. RXI-109 is its RNAi product candidate, which is a dermal anti-scarring therapy that targets connective tissue growth factor (CTGF). The Company�� therapeutic platform consists of two main components: RNAi Compounds (rxRNA) and Advanced Delivery Technologies. RNAi compounds include rxRNAori, rxRNAsolo and sd-rxRNA, or self-delivering RNA. On April 26, 2012, it completed the spin-off transaction from Galena Biopharma, Inc. (Galena).
In January 2011, the Company announced research results in collaboration with Generex Biotechnology Corporation, and RXi�� wholly owned subsidia ry Antigen Express, Inc., in developing vaccine formulations for immunotherapy. In January 2011, it announced initial results as part of its collaboration with miRagen Therapeutics, Inc. in creating microRNA mimics, or artificial copies of microRNAs, using the Company�� sd-rxRNA technology. In February 2011, it announced the initiation of RXi�� development program for RXI-109.
Best Medical Companies For 2014: Baxano Surgical Inc (BAXS)
Baxano Surgical Inc, formerly TranS1 Inc., incorporated in May 2000, is a medical device company focused on designing, developing and marketing products that implement its approach to treat degenerative conditions of the spine affecting the lower lumbar region. It develops its pre-sacral approach to allow spine surgeons to access and treat intervertebral spaces without compromising important surrounding soft tissue, nerves and bone structures. As of December 31, 2011, the Company was marketing the AxiaLIF family of products for single and multilevel lumbar fusion, the Vectre and Avatar lumbar posterior fixation systems and Bi-Ostetic bone void filler, a biologics product. All of the Company�� AxiaLIF products are delivered using its pre-sacral approach. It generates revenue from the sales of itsimplants and disposable surgical instruments. It has two distinct sales methods. The first method is when implants and/or disposable surgical instruments are sold directly to hospitals or surgical centers for the purpose of conducting a scheduled surgery. In November 2011, the Company launched its VEO Lateral Access and Interbody Fusion System.
The Company sells its products directly to hospitals and surgical centers in the United States and certain European countries, and to independent distributors elsewhere. The Company also markets its products at various industry conferences and through industry organized surgical training course. The Company has developed and markets two fusion products that are delivered using its pre-sacral approach include AxiaLIF 1L and AxiaLIF 2L+. Its products include surgical instruments for creating an access route to the L4/L5/S1 vertebral bodies, fusion implants, as well as supplemental stabilization products.
AxiaLIF Lumbar Fusion Implants
The Company markets AxiaLIF family of products for single and two level lumbar fusion, the VEO lateral access and interbody fusion system, the Vectre and Avatar posterior fixation systems and Bi-Ostet! ic bone void filler, a biologics product. The Company also market products that may be used with its AxiaLIF surgical approach, including bowel retractors, a bone graft harvesting system and additional discectomy tools. Its AxiaLIF implants and instruments, combined with facet screws or pedicle screws, provide surgeons with the tools necessary to perform a lumbar fusion.
The Company's AxiaLIF 1L and AxiaLIF 2L+ implants are threaded titanium rods, that come in varying lengths to enable one-level L5/S1 fusions and two-level L4/L5/S1 fusions. As they are implanted, its design allows for the separation of the vertebrae to restore disc height.
VEO Lateral Access and Interbody Fusion System
This system features a two-stage retraction method that focuses on nerve visualization followed by controlled retraction. The VEO Lateral System is designed for direct visualization of the psoas muscles and adjacent nerves prior to muscle dissection, and features a full range of PEEK lateral interbody implants and a variety of ergonomic instruments.
TranS1 Access and Disc Preparation Instruments
The Company�� pre-sacral approach requires the use of a sterile set of surgical instruments that are used to create a safe and reproducible working channel and to prepare the disc and vertebrae for its implant. The instrumentation contained in the set includes stainless steel navigation tools and tubular dissectors to create the working channel, as well as nitinol cutters and brushes to cut and remove the degenerated disc material and prepares the disc space for its implant and the bone graft material.
Vectre Facet Screw System
The Company's Vectre facet screw system offers a cannulated facet screw inserted over a guidewire to provide stability while reducing the muscle and tissue trauma associated with conventional pedicle screws. The Vectre system features offer a reproducible posterior fixation option in select patients.
A! VATAR Ped! icle Screw System
In January 2010, the Company entered into an agreement to distribute Avatar, a pedicle screw system. Avatar can be used with or without its implants to provide lumbar posterior fixation. The AVATAR MIS System offers cannulated pedicle screws inserted over a guidewire to reduce muscle and tissue trauma. Extended tabs integrated to the screws provide a pathway for implantation of the rod while minimizing tissue dissection.
Bi-Ostetic Bone Void Filler
In February 2010, TranS1 entered into an agreement to sell Bi-Ostetic, an osteoconductive bone substitute. Bi-Ostetic is an alternative to allografts or cadaver bone. The spongy granules are bioceramics with interconnected porosity that mimic the cancellous bone structure.
Iliac Crest Bone Graft Harvesting System
The Company�� Iliac Crest Bone Graft Harvesting System is developed to aid surgeons in harvesting iliac crest autograft via a minimally invasive approach. Use of autograft, which is osteogenic, osteoinductive and osteoconductive, further improves the chances of fusion success. It provides structural support as well as scaffolding for new bone growth.
The Company competes with Medtronic Sofamor Danek, Johnson & Johnson DePuy Spine, Stryker Spine, NuVasive, Zimmer Spine, Synthes, Orthofix International, Globus Medical and Alphatec Spine.
Best Medical Companies For 2014: Galectin Therapeutics Inc (GALT)
Galectin Therapeutics Inc., formerly Pro-Pharmaceuticals, Inc., incorporated on January 26, 2001, is a development-stage company. The Company is engaged in drug development to create therapies for cancer and fibrotic disease. As of December 31, 2011, the Company has two compounds in development, one is to be used in cancer therapy and the other intended to be used in the treatment of liver fibrosis and fatty liver disease. These two compounds are produced from different natural starting materials, both possessing the property, which lends itself to binding to and inhibiting galectin proteins. GM-CT-01, the Company's product candidate for cancer therapy, is a linear polysaccharide polymer consisted of mannose and galactose that has a defined chemical structure and is derived from a plant source. GR-MD-02, the Company's product for treatment of liver fibrosis and fatty liver disease with inflammation and fibrosis, is a polysaccharide polymer possessing both linear and globular structures, which also is derived from a plant source.
GM-CT-01 has in development for the therapy of colorectal cancer and is in a Phase I/II clinical trial as a combination therapy with a tumor vaccine in patients with advanced melanoma. Based on the completed Phase I and partially completed Phase II clinical trials, the Company is exploring two additional potential indicia for the use of GM-CT-01 in combination with cancer chemotherapy. There are two additional pathways for the development of GM-CT-01 for use in treatment of cancer. GM-CT-01 was found to be generally safe when studied in a Phase I clinical trial in end-stage cancer patients with multiple tumor types alone and in combination with 5-Fluorouracil (5-FU), which is an Food and Drug Administration (FDA)-approved chemotherapy used for treatment of various types of cancer.
Advisors' Opinion: - [By Roberto Pedone]
Galectin Therapeutics (GALT) offers drug research and development to create new therapies for fibrotic disease and cancer. This stock closed up 9.6% to $12.06 in Monday's trading session.
Monday's Volume: 674,000
Three-Month Average Volume: 222,171
Volume % Change: 149%
Shares of GALT jumped higher on Monday after Ascendiant initiated coverage on the stock with a buy recommendation.
From a technical perspective, GALT spiked sharply higher here with strong upside volume. This stock has been uptrending for the last three months, with shares ripping higher from its low of $3.95 to its recent high of $13.21. During that move, shares of GALT have been making mostly higher lows and higher highs, which is bullish technical price action. That move has now pushed shares of GALT within range of triggering a near-term breakout trade. That trade will hit if GALT manages to take out Monday's high of $12.44 and then once it clears its 52-week high at $13.21 with high volume.
Traders should now look for long-biased trades in GALT as long as it's trending above some near-term support levels at $11 or at $10 and then once it sustains a move or close above those breakout levels with volume that hits near or above 222,171 shares. If that breakout hits soon, then GALT will set up to enter new 52-week-high territory above $13.21, which is bullish technical price action. Some possible upside targets off that breakout are $15 to $16.
Best Medical Companies For 2014: Prima BioMed Ltd (PBMD)
Prima BioMed Ltd is a biotechnology company is engaged in the development and commercialization of medical therapies with a focus on oncology. Its product candidates in development include Cvac, an autologous dendritic cell vaccine for ovarian cancer, monoclonal antibodies for multiple tumour types, and an oral formulation for the human papilloma virus (HPV), vaccine. Its product candidate Cvac is a dendritic cell therapy, for which it is conducting a Phase IIb trial for the treatment of ovarian cancer. Cvac is designed to target the tumour antigen mucin-1, which is expressed at high levels on different tumour types. It also has two preclinical product development programs. In May 2011, Prima BioMed GmbH, a 100 % owned subsidiary of Prima BioMed Ltd, was incorporated in Germany. In May 2011, Prima BioMed Middle East FZLLC, a 100 % owned subsidiary of Prima BioMed Ltd, was incorporated in the United Arab Emirates.
Advisors' Opinion: - [By Monica Gerson]
Prima Biomed (NASDAQ: PBMD) dropped 38.17% to $1.45 after the company reported top-line analysis of CVac Phase 2 trial.
Tower Group International (NASDAQ: TWGP) plummeted 24.31% to $10.49. Tower Group announced its plans to release its Q2 results during the week of October 7, 2013. FBR Capital downgraded the stock from Outperform to Market Perform.
- [By Monica Gerson]
Prima Biomed (NASDAQ: PBMD) shares dipped 38.59% to touch a new 52-week low of $1.44 after the company reported top-line analysis of CVac Phase 2 trial.
Best Medical Companies For 2014: Algeta ASA (ALGETA.OL)
Algeta ASA is a Norway-based biotechnology company engaged in the development of targeted cancer therapies based on its alpha-pharmaceutical platform. The Company�� principal product is Alpharadin for the treatment of bone metastases resulting from castration-resistant prostate cancer. The Company�� pipeline also includes Alpharadin for the treatment of bone metastases resulting from breast cancer, a combination of Alpharadin with Taxotere for the treatment of bone metastases resulting from prostate cancer and Thorium-227 showing various cancer indications. The Company develops Alpharadin in a development and marketing cooperation with Bayer Schering Pharma. Algeta ASA is active through the two wholly owned subsidiaries, Algeta Innovations AS and Algeta UK Limited. On April 12, 2012, the Company announced that it estabilished a subsidiary active in the United States, Algeta US.
Best Medical Companies For 2014: Pharmacyclics Inc (PCYC)
Pharmacyclics, Inc., incorporated on April 19, 1991, is a clinical-stage biopharmaceutical company focused on developing and commercializing small-molecule drugs for the treatment of cancer and immune mediated diseases. The Company's clinical development and product candidates are small-molecule enzyme inhibitors designed to target biochemical pathways involved in human diseases. As of June 30, 2011, it had three drug candidates under clinical development and a number of preclinical lead molecules. This includes an inhibitor of Bruton�� tyrosine kinase (Btk) (PCI-32765) in Phase II studies in hematologic malignancies; a Btk inhibitor lead optimization program targeting autoimmune indications, an inhibitor of Factor VIIa (PCI-27483) in a Phase II clinical trial in pancreatic cancer, and a histone deacetylase (HDAC) inhibitor (PCI-24781) in Phase I and II clinical trials in solid tumors and hematological malignancies as of June 30, 2012.
As of June 30, 2012, the Company developed ibrutinib, which has demonstrated clinical activity and tolerability in Phase I and Phase II clinical trials in a variety of B-cell malignancies, including chronic lymphocytic leukemia (CLL) and a number of non-Hodgkin�� lymphoma (NHL) subtypes. CLL, mantle cell lymphoma (MCL), follicular lymphoma (FL), diffuse B-cell lymphoma (DLBCL) and multiple myeloma (MM) are specific indications of its current or planned Phase Ib/II and Phase III development program. had development programs for B-cell malignancies and autoimmune diseases. For malignant indications it has developed PCI-32765, which has demonstrated clinical activity and tolerability in Phase I and Phase II clinical trials in a range of B-cell malignancies, including chronic lymphocytic leukemia (CLL) and a number of non-Hodgkin�� lymphoma (NHL) subtypes. CLL, mantle cell lymphoma (MCL), follicular lymphoma (FL), diffuse large B cell lymphoma (DLBCL) and multiple myeloma (MM) are specific indications of its Phase II development. It has developed an assay! to measure occupancy of Btk in PBMCs using a cell-permeable fluorescently-labeled derivative of PCI-32765.
Factor VII is an enzyme that becomes activated (FVIIa) by binding to the cell surface protein tissue factor (TF), a protein found in the body that helps to trigger the process of blood clotting in response to injury. TF is over expressed in many cancers including gastric, breast, colon, lung, prostate, ovarian and pancreatic cancers. In these tumors, the FVIIa/TF complex induces intracellular signaling pathways by activating protease activated receptor 2 (PAR-2), another cell-surface protein. This in turn increases the expression of interleukin-8 (IL-8), a protein produced by white blood cells and other immune cells in response to pathogenic stimulation, and vascular endothelial growth factor (VEGF), a signal protein produced by cells that stimulate the growth of blood vessels. Both proteins play an important role in tumor growth and metastases as well as angiogenesis (growth of new blood vessels). FVIIa/TF complex also initiates the coagulation (a process by which blood forms clots) processes implicated in the high incidence of thromboembolic (the process by which the blood clots within a blood vessel) complications seen in patients with TF-expressing cancers. Thromboembolic events are a cause of death in patients with cancer and anticoagulant treatment has been shown to improve survival in a variety of cancers (Klerk et al. JCO. 2005).
PCI-27483 Factor VIIa Inhibitor
The Company�� Factor VIIa inhibitor PCI-27483 is a first-in-human small molecule inhibitor that selectively targets FVIIa. As an inhibitor of FVIIa, PCI-27483 has two potential mechanisms of action: inhibition of intracellular signaling involved in tumor growth and metastases and inhibition of early coagulation processes associated with thromboembolism.
Factor VIIa PCI-27483 Clinical Development Update
A multicenter Phase I/II of PCI-27483 in patients with locally a! dvanced o! r metastatic pancreatic cancer that are either receiving or are planned to receive gemcitabine therapy has completed enrollment. The Phase II portion of the study randomized patients to receive either gemcitabine alone or gemcitabine plus PCI-27483 (1.2 mg/kg twice daily). The objectives are to assess the safety of FVIIa Inhibitor PCI-27483 at pharmacologically active dose levels, to assess potential inhibition of tumor progression and to obtain initial information of the effects on the incidence of thromboembolic events. Due to a paradigm shift away from the use of gemcitabine alone for the treatment of pancreatic cancer, enrolling patients in this randomized study has been challenging. PCYC is evaluating other alternatives for development of this agent.
A multicenter Phase I/II of PCI-27483 in patients with locally advanced or metastatic pancreatic cancer that are either receiving or are planned to receive gemcitabine therapy has completed enrollment. The Phase II portion of the study randomized patients to receive either gemcitabine alone or gemcitabine plus PCI-27483 (1.2 mg/kg twice daily). PCI-27483 is covered by United States patents and patent applications and counterpart patents and patent applications in fourteen ex-United States territories, including Europe, Canada, Mexico, Japan, China, India, South Korea, Australia and Brazil.
Advisors' Opinion: - [By Ben Levisohn]
[The] sell-off in recent days was broad based and…affecting stocks in direct relationship to their volatility and expected duration of negative cash flow. Small and mid cap stocks were most affected (especially post-IPO stocks), and those with major uncertain events looming (MDVN) or with significant revenue upside already built into valuation (PCYC) were among the most severely affected. However, nothing changed in the environment to suggest that those events were any more or less likely to have positive outcomes yesterday, or to suggest that revenue potential was any more or less likely to be achieved than was previously expected.