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Helix BioMedix, Inc. (OTC:HXBM), a developer of bioactive peptides, announced financial results for the third quarter ended September 30, 2009.
Laboratory Corporation of America® Holdings (NYSE:LH) announced William B. (Brad) Hayes, Executive Vice President and Chief Financial Officer, is scheduled to speak at the Credit Suisse 18th Annual Healthcare Conference in Phoenix AZ.
Oncolytics Biotech Inc. (NASDAQ:ONCY) announced updated results from a Phase II study of intravenous REOLYSIN(R) in patients with sarcomas metastatic to the lung in a poster presentation at the 15th Annual Connective Tissue Oncology Society Meeting held in Miami Beach, Florida, from November 5th to 7th.
PPD, Inc. (Nasdaq:PPDI) announced it has completed its acquisition of Excel PharmaStudies, Inc., the market leader and one of the largest contract research organizations in China.
Imagenetix, Inc. (OTC:IAGX), announced today that William Spencer, President and CEO of Imagenetix, will be presenting the Company's store at the 2nd annual LD MICRO Conference on Thursday, December 3rd, at 10:30 AM PST at the Luxe Sunset in Los Angeles.
Amarin Corporation plc (NASDAQ:AMRN) announced the appointment of John F. Thero as the Company’s Chief Financial Officer.
Phase Forward (NASDAQ:PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced the Mass Technology Leadership Council, Inc. named Phase Forward Private Sector Company of the Year at the 2009 Mass Technology Leadership Awards in Boston last night.
BioSpecifics Technologies Corp. (Nasdaq:BSTC), a biopharmaceutical company developing first-in-class collagenase-based products, announced its financial results for the third quarter ended September 30, 2009.
Caraco Pharmaceutical Laboratories, Ltd. (NYSE:CPD) has launched ketorolac tromethamine ophthalmic solution, 0.5% following a final approval from the US Food and Drug Administration (FDA) for Sun Pharma's Abbreviated New Drug Application (ANDA) for generic Acular® ophthalmic solution on the first day following patent expiration.
Stellar Pharmaceuticals Inc. (OTC:SLXCF), a Canadian pharmaceutical developer and marketer of high quality, cost-effective products for select health care markets, announced its financial results for the third quarter ended September 30, 2009.
Cyberonics, Inc. (Nasdaq:CYBX) announced the company will report financial results for the second quarter ended October 23, 2009 of its fiscal year ending April 30, 2010 on Wednesday, November 18, 2009 at 5:00 PM EST.
GeoVax Labs, Inc. (OTC:GOVX), an Atlanta-based, biopharmaceutical company developing human vaccines for disease caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents, today announced its third quarter 2009 financial results and provided an operational update.
Ardea Biosciences, Inc. (Nasdaq:RDEA), a biotechnology company focused on the development of small-molecule therapeutics for the treatment of gout, cancer and human immunodeficiency virus (HIV), today reported recent accomplishments and financial results for the third quarter and nine months ended September 30, 2009.
Covidien (NYSE:COV), a leading global provider of healthcare products, announced the successful completion of its tender offer through its subsidiary, Transformer Delaware Corp., to purchase all of the outstanding shares of common stock of Aspect Medical Systems, Inc.
PharMerica Corporation (NYSE:PMC), a national provider of institutional pharmacy and hospital pharmacy management services, announced Gregory S. Weisner, Chief Executive Officer, will make a presentation regarding the Company at the Credit Suisse 18th Annual Healthcare Conference in Phoenix, Arizona, on Wednesday, November 11, 2009, at 10:00 a.m. Mountain Time.
Ferro Corporation (NYSE:FOE) announced it has closed on its previously announced common stock offering. The total number of shares sold was 41,112,500, including 5,362,500 shares issued in connection with the exercise of the underwriters’ over-allotment option to purchase additional shares.
Boston Scientific Corporation (NYSE:BSX) announced it has reached an agreement in principle with the U.S. Department of Justice (DOJ) related to product advisories issued by its Guidant subsidiary in 2005.The alleged conduct and product sales occurred prior to Boston Scientific's 2006 acquisition of Guidant.
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) will hold a conference call on Tuesday, November 10, 2009 at 8:30 a.m. EST to discuss the third quarter 2009 financial results and business outlook for the remainder of 2009.
The Quigley Corporation, (Nasdaq:QGLY), www.quigleyco.com, announced it would issue its third quarter results at 8:30 AM (ET) on Thursday, November 12, 2009.
The Company's next-generation screening test (V3) for colorectal cancer (CRC) holds the promise to detect both early-stage cancer and pre-cancerous growths. This stool-based DNA (sDNA) screening technology platform also has the potential to develop tests in the future for the early-stage detection of related cancers (e.g. stomach, pancreas, etc.). Rather than spending thousands on expensive treatments for patients with late-stage CRC; the focus of healthcare reform should be in the development of improved screening tests that will result in the detection of both pre-cancerous lesions and early-stage disease.
On 6/11/09, EXAS announced a collaboration and licensing agreement with the Mayo Clinic along with the closing of an $8.2 million (M) private placement for 4.3M shares of its common stock (with XMS Capital Partners serving as the Company's financial advisor). Including the newly-issued shares as part of the private placement, EXAS has about 35M shares of common stock outstanding for a market cap of about $95M as of mid-July with a stock price around $2.70 per share.
The pact with the Mayo Clinic is focused on developing patient-friendly diagnostics that reduce deaths from CRC. According to projections by the American Cancer Society (ACS) there will be 146,970 new cases of CRC and nearly 50,000 deaths attributable to the disease in 2009 in the U.S. alone, representing the second most common cause of cancer-related death following lung cancer (60,000 deaths) and ahead of breast cancer (about 41,000 deaths).
Under the license agreement, EXAS has secured exclusive rights to intellectual property (IP) developed by David Ahlquist, M.D., Mayo Clinic, including patents that cover advances in sample processing, analytical testing and data analysis associated with non-invasive, sDNA screening for CRC. EXAS will make up-front, milestone, and royalty payments to the Mayo Clinic and will provide funding for future work in Dr. Ahlquist's lab in exchange for the exclusive rights to commercialize any promising results from this collaboration.
A week after the Mayo Clinic deal, EXAS announced that it received a $1M loan from the Wisconsin Department of Commerce to relocate its headquarters and operations from Marlborough, MA, to Madison, WI. The Company's expansion plans include the creation of up to 150 jobs over five years as EXAS achieves commercial milestones for its non-invasive sDNA screening test for the early detection of CRC. The relocation to Madison follows a management overhaul in March that brought a new leadership team from Third Wave Technologies, including the new President & CEO, Kevin Conroy.
Third Wave was acquired by Hologic (NASDAQ:HOLX) in 2008 for $582M, and the management team now at EXAS led the development through FDA approval for two human papillomavirus (HPV) molecular diagnostic tests in addition to a test for cystic fibrosis. The new executive leadership team is expected to restore investor confidence in EXAS once their strategic plan is communicated to correct the backwards development of the Company's promising sDNA technology for the average risk population in the detection of CRC.
EXAS secured inclusion for its sDNA technology in the World Gastroenterology Organization, U.S. Multi-Society Task Force, and ACS guidelines for CRC screening before successfully developing a FDA-approved, fully automated test to fully capitalize on this major commercial and preventative medicine (i.e. saving lives) opportunity. Thus, LabCorp (NYSE:LH) currently markets ColoSure on a homebrew basis with little in the way of sales or third-party reimbursement (i.e. insurance or government) - which is unlikely to change until FDA approval is secured for the Company's V3 technology.
The exclusive agreement with LabCorp runs through the end of 2010 for the use of EXACT's IP as part of a commercial testing service for CRC screening, which was launched as ColoSure last summer by LH on a homebrew, non-FDA approved basis. ColoSure is a single-marker sDNA test for the detection of CRC at all stages for asymptomatic, average-risk patients who are unwilling or unable to undergo a more invasive structural exam such as colonoscopy (the current gold standard). Published studies involving patients known to have invasive CRC show that ColoSure has a sensitivity range of 72-77% and a specificity range of 83-94% while the detection rates for general population screening have yet to be determined.
During Mr. Conroy's tenure as chief executive of Third Wave, he oversaw the development of two human papillomavirus (HPV) molecular diagnostic tests, including their successful clinical development. Importantly, both of Third Wave's HPV tests secured FDA marketing clearance, in addition to the Company's InPlex cystic fibrosis test.
For 1Q09, EXAS reported revenue of $1M and a net loss of $3.8M, ending the quarter with cash and equivalents of $20.6M (which excludes the recently announced $8.2M private placement) and zero debt. The increase in cash and revenue largely reflects the Company's strategic pact with Genzyme (NASDAQ:GENZ) announced in early 2009 as part of an intellectual property transaction that generated $17.2M in proceeds for EXAS that will be recognized as revenue over 20 quarters as a non-cash allocation.
EXAS provided guidance that cash/equivalents as of 1Q09 would be sufficient to fund operations for at least 12 months, but stated the Company would require additional funding to complete the clinical development required for FDA marketing clearance of its next-generation sDNA CRC screening test. Subsequently, EXAS received an additional $8.2M in proceeds from a private placement, extending the Company's operating liquidity until at least late 2010 - in addition to future licensing opportunities for the fully-automated, V3 test being developed to obtain a broad label from the FDA.
Terms of the deal call for GENZ to acquire select IP of EXAS related to prenatal diagnostics and reproductive health while EXAS retained the rights to its key asset, a FDA-approved version of its next-generation (V3) sDNA test, which represents a much larger commercial opportunity than prenatal diagnostics. EXAS will also receive a double digit percentage of any sublicensing income that GENZ receives related to IP it purchased outside of prenatal/reproductive.
EXAS enjoys a strong patent estate for CRC screening, including the following: (1) platform technology: exclusive licenses to digital PCR and BEAMing technology (both stool + peripheral blood detection) from Johns Hopkins University (JHU) for the detection of CRC; (2) content: APC (adenomatous polyposis coli)and p53 (these are two common genetic mutations associated with CRC) licensed from GENZ with diagnostic testing kit rights + exclusive licenses to key tumor biomarkers such as Vimentin; (3) methods: broad IP for stool sample processing.
The deal included the purchase of 3M shares of EXAS common stock by GENZ at $2 each ($6M), an upfront cash payment of $16.65M, and an additional $1.85M to be received over an 18-month period for $24.5M in total cash proceeds associated with the deal. Aside from the obvious benefits of the immediate cash infusion, EXAS now has access to the product development and regulatory expertise of GENZ, in addition to its global distribution network.
Adding further value to the Company's non-invasive sDNA CRC screening IP, the results of a population-based, case-control study published in the medical journal, Annals of Internal Medicine, concluded that colonoscopies may actually prevent 60%-70% of CRC, rather than the previously quoted rate of 90% for the test. While colonoscopies are still effective at preventing CRC and will continue to be widely recommended and used; the study highlights limitations of the procedure - especially in the detection of flat and right-sided lesions, with the latter accounting for about 40% of all CRC cases.Sensitivity results of 82% were already published last summer for the Company's V2 sDNA technology, while the next-generation sDNA test (V3) boasts 92% sensitivity and has shown the potential to detect 86% of precancerous adenomas. Currently, only 24% of the 90M eligible patients in the U.S. are compliant with CRC screening recommendations and there is clearly an unmet medical need for an effective, non-invasive CRC screening test for the average-risk population which people will actually use.The potential for an effective, non-invasive CRC screening test for the average risk population is also a global opportunity as a report concluded that the E.U. needs to double the current rate for cancer screenings in order to reduce preventable deaths. The report calls on the 27 member countries to improve large-scale screening programs for target groups regardless of their symptoms, and only 12 member countries currently have programs for CRC screening.Developing a V3 sDNA CRC screening test will be the focus of EXAS now that it has secured much of the funding necessary to see it through 2011, when it expects to submit for FDA approval of the V3 CRC screening test. EXAS will design the clinical trial based on extensive input from the FDA from last year, along with input from GENZ in the form of the joint advisory committee. EXAS may pursue a CLIA or homebrew launch of a V3 test by early 2011 and will also evaluate other opportunities such as aero-digestive cancer screening tests.
The clinical trial for FDA marketing clearance of the V3 test will include 8,000-10,000 subjects enrolled at 30-40 clinical sites with a goal of obtaining broad claims as a non-invasive sDNA-based CRC screening test, including the detection of adenomas. The new executive management team has extensive experience in conducting these types of oncology screening clinical trials, and the successful decline in cervical cancer mortality provides a benchmark for success in decreasing the mortality and increasing the early-stage detection of CRC.
Pap Screening has reduced cervical cancer mortality by 74% from 1955-1992 (with less than 4,000 deaths per year now from the disease. Characteristics for a successful screening test in the setting of oncology include the following: (1) the test must detect both cancers and pre-cancers; (2) regular testing intervals to allow for the removal of tumors without the need for chemotherapy; and (3) the removal of pre-cancerous lesions to reduce the occurrence of disease and overall mortality. Only sDNA-based screening tests allow for the non-invasive, patient-friendly detection of both cancers and pre-cancers, which can be combined with colonoscopy + pre-cancer removal for a drastic reduction in CRC mortality.
Last summer, EXAS announced the published results of a study in which stool and blood plasma were compared head-to-head for the detection of CRC using an improved BEAMing DNA detection technology (V3) from JHU. Study results demonstrated 92% sensitivity for detecting CRC in stool samples, which outperformed blood plasma testing - especially in the detection of early stage disease, which is crucial to have a positive impact and decrease mortality as CRC has a much better treatment outcome when diagnosed at early stages.
BEAMing describes an assay technology which incorporates the use of "Beads, Emulsion, Amplification, and Magnetism". The technology is a useful method for performing single-molecule analysis of DNA or "Digital PCR" that has been demonstrated to provide a high level of sensitivity for the detection of mutations or deletions in gene sequences of interest.
In the study, a total of 25 sDNA samples from CRC patients were analyzed and a next generation sDNA technology (V3) correctly identified 23 (92%) of the cancers. In the 16 of 25 cases where there were paired stool and plasma DNA samples, the sDNA technology detected mutated DNA in stool in 14 cases (88%) while only 8 (50%) corresponding plasma DNA samples had detectable levels of mutated DNA. In addition, when late-stage disease (Stage IV) is removed from the total, non-invasive sDNA performance remained at 86% (12/14) while plasma DNA performance fell to 43% (6/14). The results of the study, Analysis of Mutations in DNA Isolated from Plasma and Stool of Colorectal Cancer Patients, were published in the August journal of Gastroenterology.
Only 24% of an estimated 90M individuals in the U.S. are currently compliant with CRC screening recommendations, which results in 68M people who are non-compliant. The early detection of CRC saves both lives and money by avoiding the high costs of dealing with late-stage disease through expensive anti-cancer drugs and/or palliative care. Late stage (III/IV) CRC accounts for 60% of diagnoses, but the five-year survival rates for Stage III CRC is 60% and just 11% for Stage IV disease. Compare those stats to early stage disease, which includes a 90% five-year survival rate for Stage I CRC and 70% for Stage II.
A five-year interval for sDNA CRC screening would equate to about 16M people in the U.S. alone eligible for annual screening; while a three-year interval ups the number to 27M. If about one-third of those eligible for annual screening underwent sDNA screening for CRC; the market opportunity would be around 5M patients per year for a five-year interval and 9M for the three-year interval. At an estimated price of $100/test and 20% royalties, EXAS could earn $100-$180M per year in royalty revenue (about 2X the current market cap) based on these conservative estimates for market adoption and pricing.
Using $140M as the mid-point for potential royalty revenue in 2012 at a price/sales ratio of 3-5X discounted back three years at 20% annually yields a price target range of about $6-$10 per share for EXAS. Significant upside is possible based on wider adoption of preventative medicine initiatives in the U.S. and worldwide, especially in the area of screening tests for the early detection of cancer. Please visit the stock research section of BioMedReports.com to view or download the stock profile report for EXAS.
1.) A 53% increase in diagnostic lab revenues during 2Q09 from the year-ago period
2.) A 17% sequential decline in diagnostic lab revenues from the prior quarter due to temporary factors that are expected to be resolved in near-term
3.) Leuchemix clinical trials are progressing well
4.) Positive data was reported on the Company's Comprehensive Cancer Array (CCA) test, which is currently in development
The Company attributed its sequential revenue decline to non-recurring events including a short delay in the initiation of a funded, 200-patient prostate cancer study that is now expected to be completed by the end of 2009. Also, CBMX was unable to perform its tests for residents of the state of New York (NY), which represents one of its fastest growing markets.
When new tests are developed, NY allows them to be operated on residents for a certain period of time but eventually requires state licensure (in addition to CLIA licensure) for high complexity tests. During 2Q09, NY informed the Company that it was no longer acceptable to offer its tests under the exemption and state licensure was required. CBMX has applied for the license and hopes to receive approval shortly.
CBMX also announced that it is seeking to engage an investment bank to aid in its efforts to unlock shareholder value and hopes to hire and announce an engagement very shortly. The Company stated that it has reached an inflection point in its strategy and has a relatively strong balance sheet with approximately a year of cash reserves remaining as well as an additional potential payment of about $36 million from a previously awarded court judgment against National Union that is pending a final ruling on appeal by the latter.
The Company stated that in addition to its diagnostic assets, it owns other assets that include an ownership position (one-third stake) in the experimental anti-cancer drug Leuchemix, which is being evaluated in a dose-escalating Phase 1 safety study in England with a goal of completing a Phase 2 trial by mid-2010 and seeking a partnership to fund Phase 3 development. The CEO stated that CBMX has conducted discussions with some companies that have expressed interest in acquiring or partnering with the Company or certain portions thereof.
CBMX also provided the following corporate, product, and technology updates:
1.) In April 2009, Dr. Karine Hovanes joined the Company's wholly owned subsidiary, CombiMatrix Molecular Diagnostics, Inc. (CMDX), as Laboratory Director.
2.) Also in April 2009, CBMX announced that its Influenza-Detection Microarray was updated to include sequence information covering the latest strain of swine flu.
3.) In May 2009, CBMX provided a link on its website for a presentation by its CEO, Dr. Amit Kumar, regarding the latest developments for its non-invasive, array-based cancer screening test (CCA)
4.) In June 2009, the Company was featured in a report that was broadcast on CNBC after announcing that a validation study of its HerScan breast cancer test was now available as advance online publication in the official journal of the United States and Canadian Academy of Pathology, Modern Pathology.
5.) In June 2009, CBMX announced that all of the appellate briefs associated with ongoing litigation against National Union were filed with the U.S. Ninth Circuit Court of Appeals and that the next step in the appellate process is for the Court to schedule oral hearings. A final decision could be reached during 4Q09, resulting in a major cash windfall to the Company which is nearly equal to its current market cap of about $50 million (7.5 million shares outstanding X $6.63/share).
Preliminary results for the CCA test have demonstrated that it can non-invasively screen for the early detection of cancer, focusing on prostate, colon, ovarian, breast, and lung cancers (which account for about 85% of all solid tumors in the U.S.). The study showed that the miRNA (type of nucleic acid) expression patterns in the blood for patients with cancer (including early stage 1) were very different from patients who were cancer-free. An analysis of results indicated that a clear distinction could be made between patients with cancer and those without.
A broad-based, early detection test for cancer would have tremendous market potential and fits well with the focus on preventive medicine by the new administration. This early warning system for cancer is designed to be a non-invasive, blood screening test which would require confirmation of results by a follow-up, invasive method such as a biopsy. CBMX estimates the market potential for the CCA at several billion dollars per year in the U.S. alone, which is based on $250 per test administered to 50M people each year over the age of 40 who are believed to have an annual physical exam.
On 5/13/09, CBMX announced that its goal is to complete the R&D phase for the first version of the array by the end of the third quarter of 2009. While the initial focus is on colon, lung, breast, ovarian, and prostate cancers, CBMX has not yet publicly disclosed the specific cancers which will be on the first version of the test. By the end of 2009, the final protocols, assay development and quality control metrics are expected to be completed. During 1H10, CBMX hopes to complete clinical trials in anticipation of a commercial launch during 3Q10. In parallel with the development of this array, CBMX will be engaged in partnership discussions.
The Company's CMDX lab division could easily be worth up to 2X the current market cap for CBMX of $50 million based on recent transactions for two companies in my Emerging Diagnostics Index. EXACT Sciences (NASDAQ:EXAS) closed a deal with Genzyme (NASDAQ:GENZ) earlier this year for $24.5 million for the rights to its IP/patent estate in the area of prenatal diagnostics (please note this transaction does not even include a finished test).
In addition, LabCorp (NYSE:LH) recently acquired Monogram Biosciences (NASDAQ:MGRM) for a total value of about $150 million. Monogram’s proprietary VeraTag technology has been used to develop a sensitive means to assess HER-2 status in tissue samples and has significant potential as a tool to help guide therapy decisions in breast cancer patients. Based on the VeraTag platform, Monogram has multiple tests in development for measuring a variety of protein markers that may have clinical utility to help guide treatment decisions across a broad range of cancer drugs.
Analysts were expecting Genomic Health Inc. (GHDX) [Chart - News - Analysis] to report earnings of $-0.10 for last quarter, but GHDX beat expectations with actual earnings of $-0.02---8 cents above the consensus estimate.
If you compare last quarter's earnings to the $-0.11 the company made per share during the same quarter a year ago, you can see that GHDX’s earnings are up this year.
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Also, if you compare GHDX's 15.00% projected earnings-per-share (EPS) growth rate for the next five years with the projected EPS growth rate of 14.21% for the Medical Laboratories & Research industry as a whole during that same time frame, you can see that analysts expect GHDX to outperform the industry in the future---which is a good sign for the stock.
Drilling down a little deeper into the Medical Laboratories & Research industry, you can see how analysts believe GHDX will stack up against some of the other stocks in the industry, like Pharmaceutical Product Development Inc. (PPDI) [Chart - News - Analysis] and Laboratory Corp. of America Holdings (LH) [Chart - News - Analysis], in the future. Analysts believe PPDI's earnings are going to grow at a rate of 13.60% while LH's earnings are going to grow at a rate of 12.28%.
Earnings season can be a volatile time in the stock market. Check out these videos and articles to be better prepared to take advantage of the large price moves that tend to accompany earnings announcements.
This past Monday top value investors from across the country gathered in New York to discuss their investment ideas at the 5th annual Value Investing Congress. I was planning to attend, but some unforeseen events back at home prevented me from traveling to New York. Thankfully, since I was registered for the event, I have [...]
Companies featured in this segment: Bristol-Myers Squibb Company’s (NYSE:BMY), Laboratory Corporation of America (NYSE:LH), BP plc (NYSE:BP), The Blackstone Group LP (NYSE:BX), General Electric Company (NYSE:GE), StatoilHydro ASA (NYSE:STO), SNC-Lavalin Group Incorporated (TSX:SNC), and Alstom SA (EPA:ALO)
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