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So, NEO is not a competitor of FMI, although NEO's customers might be. (FMI does have its own CLIA-certified lab.)
No, I would say that they are a competitor, particularly in the hematological oncology space. They appear to have a suite of tests that distinguishes blood based cancers. They also appear to have a competing CRC division that may be more well developed than NEO's. I haven't dug deeply enough into FMI's quarterly statements to be able to discuss just how much of their revenue comes from the CRC business, but I know that NEO had a big agreement with Covance that is now in question since LH bought Covance out. FMI seems to be more focused on direct patient contact (if you look through their website) but I would expect that they are booking most of their revenues through oncology and pathology-based physician practices.
VRX acquires SURG for $6.50/sh in cash plus contingencies
I've had SURG on my watch list for 3 years for this very reason but never pulled the trigger. BABY is on my watch list for the same reasons but will cost much more.
NEO vs. FMI
I can't tell whether FMI is a CLIA certified testing lab or not. They appear to have qualified genetics testing with personalized treatment recommendations based upon their results but it unclear whether they are using their own labs or not. NEO is a CLIA certified lab service and I have never heard of them making specific recommendations about treatment pathways based upon results. They leave those decisions up to te oncologists and pathologists who request the testing. NEO appears to have a briader array of tests as well.
aj
NEO"NeoGenomics Enters into National Agreement with Premier, Inc. to Offer Cancer Genetics Testing Services to 3,600 Hospitals"
FT. MYERS, Fla., Sept. 2, 2015 /PRNewswire/ -- NeoGenomics, Inc. (NEO), a leading provider of cancer-focused genetic testing services, announced today that it has entered into a national group purchasing agreement with Premier, Inc. Premier is a leading healthcare improvement company uniting an alliance of approximately 3,600 U.S. hospitals and 120,000 other providers, and is widely recognized as operating one of the largest healthcare group purchasing organizations (GPO) in the United States.
The three year agreement secures for NeoGenomics the distinction of becoming the first specialized oncology reference laboratory to become a preferred in-network lab option for all Premier member hospitals, cancer centers, pathology groups, and oncology/physician providers nationwide.
The agreement is comprehensive in nature, and includes full access to the entire menu of oncology testing services offered by NeoGenomics, including NeoGenomics' industry-leading line of innovative and cost-effective NeoTYPE™ Cancer Profiles based on Next Generation Sequencing (NGS). These new advanced cancer-profiling tools offer oncologists and pathologists a more targeted and comprehensive ability to tailor cancer testing to an individual patient's needs than has ever been available before.
Douglas VanOort, NeoGenomics' Chairman and Chief Executive Officer, stated, "We are extremely honored to have been selected by Premier to be their first specialized oncology reference lab. Premier's membership includes more than half the hospitals in the United States and many important oncology and pathology practices that we believe will benefit from our full line of cancer genetic testing services."
http://finance.yahoo.com/news/neogenomics-enters-national-agreement-premier-110000568.html
This is good news indeed!
aj
NXTM "American Journal of Kidney Disease Publication Confirms Significant Patient Advantages with HHD versus PD
NxStage® Medical, Inc. (NXTM) a leading manufacturer of dialysis products, today announced online publication in the American Journal of Kidney Disease (AJKD) of results from the largest study of its kind that assessed relative mortality on frequent home hemodialysis (HHD) versus peritoneal dialysis (PD) as well as relative all-cause hospitalization. The data show that frequent HHD patients have a lower risk of death, hospitalization and therapy attrition than PD patients.
A 38-factor algorithm matched 4,201 frequent HHD patients with 4,201 PD patients. Results showed lower risks of death due to cardiovascular disease, infection, and either cachexia or dialysis withdrawal with frequent HHD therapy. Results also showed 15 percent lower risk of hospitalization due to cardiovascular disease and 11 percent lower risk of hospitalization due to infection with frequent HHD therapy.
"Home dialysis is growing, but there are few studies that compare clinical outcomes with HHD and PD," said Weinhandl. "This study suggests that frequent HHD may offer important advantages, especially with respect to reducing cardiovascular risk and keeping patients in their homes."
The study also included detailed analysis of patients that began dialyzing in their homes within the first six months of being diagnosed with end stage renal disease, during which time patients typically start PD. In this group, frequent HHD patients had similar risks of death and hospitalization as PD patients and 30 percent lower risk of therapy attrition.
"Published studies consistently report improved survival, improved quality of life and other important benefits for home hemodialysis patients," said NxStage president, Joseph Turk. "These particular findings challenge conventional thinking within the renal community and should compel clinicians to consider frequent HHD a life-changing therapy choice for patients who are considering at home dialysis."
http://finance.yahoo.com/news/american-journal-kidney-disease-publication-120000604.html
Home Hemodialysis is a significant market for NXTM and they are moving aggressively to grow this. The findings are a validation of their business model.
Addyi Just 2 C here but I wonder why these smart chemists don't just figure a milder analogue to methylqualone and use it for the same purposes. It sure as sh*t will have a more predictable positive effect and can be used prn, much cheaper than this new player.
aj
MCUJF-"Why would sales of Aggrestat double this late in the game? Aggrestat has been on the market since 1996, and there are several newer and better options for platelet inhibition."
Exactly, but the company has taken this product and doubled sales in the last year. Each new double in sales will be more and more difficult, but not an insurmountable task given the low bar of $30 million/year given the size of the emergency anticoagulant market. The fundamental question(s) are more likely related to where AGGRASTAT is being sold, pricing, and, how does one put it, " easing market acceptance" of a cost/benefit if this is taking new customers because it's price advantage is greater than the inferiority issues. From what I've read (and it's admittedly a cursory review), AGGRASTAT has acceptable costs vis a vis side effects and efficacy limits.
I know of many settings in mental health (my bailiwick) where insurance medication benefit is a cost issue and inferior medications that are cheaper are the only covered meds.
MCUJF-Tiny sales compared to most marketed drugs, but they have turned profitable and if they can double sales to $30 million, they would have revenues equal to market cap, so there is at least a technical attractiveness here for a modest investment.
MCUJF: An interesting find, ronpopeil. Can you provide any details of your investigation(s) on the co., AGGRASTAT, or their development drug(s) that you think make for a compelling investment opportunity here. I did a cursory search and cannot find whether or not AGGRASTAT is patent protected and/or how long it will be. The drug appears to have been around for some time. One study (2001) of head to head comparison with another Platelet Glycoprotein IIb/IIIa Inhibitor found that AGGRASTST was inferior to the compared medication (abciximab), even though the study was designed for simple non-inferiority.
http://www.nejm.org/doi/full/10.1056/nejm200106213442502
RMTI- Beat me to the punch (with a little more concise response) by a couple of minutes.
aj
RMTI- Any opinions
I have tracked this co for some time but have never felt the need to pull the trigger and invest. The main business for the co. (dialysis supplies) has been luke-warm at best, and poor in terms of market share growth. The margins are small and the competition is great. Sure, they now have an Iron replacement supplement that is novel, but the question remains regarding adoption of a new replacement (at likely high retail costs) versus an entirely adequate replacement regimen that is low cost and easily managed. Now consider this: the company has a sales force that is relatively small and NOT in the drug sales end of this business. True, they have customers who might be interested, but significant sales would have to come from outside of their customer network. One would hope for some type of partnership or licensing deal, but there appears to be more work to be done with regard to pre-marketing preparations. From today's PR:
"Since our FDA approval of Triferic, interest from the clinical community in gaining access to the drug has been strong across large and small dialysis organizations. Short-term pilot evaluations are being coordinated among some of the larger groups to establish internal protocol, prior to clinic-wide use. We anticipate these pilot studies will begin in the next few weeks. Once internal protocols are established and working satisfactorily, we expect to see broad-based clinical adoption of Triferic.
I don't think that sales will be nil, but I'm not holding my breath for gangbuster sales either. I continue to monitor.
aj
NEO launches BRCA1/BRCA2 test:
NEO continues to launch new tests, keeping up with the market. If you missed this announcement, they also recently launched the following:
NeoGenomics Launches Twelve NeoLAB™ "Liquid Biopsy" Tests for Hematologic Diseases
https://finance.yahoo.com/news/neogenomics-launches-twelve-neolab-liquid-110000440.html
Given the intrusive nature of marrow biopsies, I would think that liquid biopsies would be quite attractive as an alteernative.
Liquid biopsies are getting quite a bit of press and research:
http://cancerres.aacrjournals.org/content/73/21/6384.short
AKAO: Iwfal, thanks for your reply. Your analysis is exactly what I wanted to get as I was also somewhat concerned about the posted previous results but don't know enough about this class of antibiotics.
AKAO-The text you excerpted has a notable omission: the statistical power of the trial.
And there was no mention of statistical power in the PR. A review of the trial at clinicaltrials.gov has nothing to say about this as well. Does the listing of the protocol on clinicaltrials mean that the design has been signed off by the FDA?
AKAO: Anyone on this board following Achaogen, a clinical antibiotic drug development company? I've been looking through their site and data on their lead candidate, plazomicin and the data is respectable (at least from what I can see.) The co. looks well enough funded for their phase 3 trial, to begin in Q4, 2015. However, the statement below is something of a concern regarding the sample size. Please feel free to chime in if you have an opinion regarding the co. the sample size statement, or other thoughts/opinions regarding this co.
The Phase 3 cUTI trial will be a randomized, double blind, active controlled study in patients with cUTI and acute pyelonephritis. This will be a non-inferiority trial comparing plazomicin to meropenem with a 15% non-inferiority (NI) margin. As such, the trial will have a sample size of approximately 530 patients, which is significantly smaller than prior industry-sponsored Phase 3 cUTI trials. The Company believes that this reflects the FDA's recognition of the unmet need for new antibiotics that treat MDR bacterial infections with high morbidity and mortality. The Company estimates the Phase 3 cUTI trial will necessitate additional Achaogen funding of $45-50 million from 2015 through 2017, which the Company anticipates will be primarily accessed via non-dilutive sources such as government contracts, grants, and debt.
http://www.achaogen.com/
NEO Neogenomics is gapping up today on no news. The scuttlebutt on YMB is that the decision by CMS to increase pathology testing reimbursement by 8% may be the cause. The company reports on 7/23. I anticipate numbers that beat the street estimates, but this kind of move suggests that something else is also in the works.
Here's the PR about reimbursement:
http://www.medpagetoday.com/PracticeManagement/Reimbursement/52505
There is also some "pain" in the CMS proposal: gastroenterologists are getting cut 5% and radiation oncologists face a 3% pay cut. But pathologists are the big winners with an 8% raise.
NXTMI’d bet that BAX (the world leader in peritoneal dialysis) has studies it could cite to rebut NXTM
I haven't looked at that literature in some time. If you find something, please post it (or send it to BAX's PR dept., I'm sure they'd appreciate it ;) ).
Maybe NXTM is trying to bait BAX a little and get their attention. No one else appears to be paying any attention to NXTM.
I continue to hold.
best,
aj
ISR: This is now two days old and can be considered "old news" but a good example of share price manipulation. The number of suits being prepared should give pause to any mgmt team going forward. ISR is dead money for a long time, IMO.
IsoRay Takes Liberties With Lung Cancer Study Results to Prop Up Stock Price
RICHLAND, Wash. (TheStreet) -- IsoRay (ISR - Get Report) does a poor job selling radioactive "seeds" for use in cancer radiation therapy. To make up for the inability to deliver revenue growth -- and prop up its stock price -- IsoRay issues a lot of promotional press releases, some of which take liberties with clinical data using clever, selective editing.
Take Wednesday's IsoRay announcement about the publication of a study involving use of the company's seed brachytherapy product Cesium-131 to treat patients with early-stage lung cancer after surgery. The press release headline reads, "IsoRay's Cesium-131 Lung Cancer Treatment Reports 96% Success in Local Control and 100% Survival at 5 Years in High Risk Patients in Newly Published Report."
100% survival! That's an attention grabber. The IsoRay press release about the study goes on to describe the Cesium-131 results as "outstanding." Twice.
IsoRay shares almost doubled in price to $3.12 Wednesday. The stock is up another 3% Thursday.
Few investors are reading the actual study involving Cesium-131 published in the medical journal Brachytherapy. If they read the study -- and I did -- you'd see IsoRay is lazy with the facts.
Yes, 96% of lung cancer patients demonstrated "local control" (meaning control of tumor in the lung) following surgery plus treatment with Cesium-131. But two other groups of lung cancer patients in the Brachytherapy study who had either surgery alone or a different form of radiation therapy demonstrated statistically equivalent rates of local control. The study authors note there were no differences in local control rates between the groups of lung cancer patients.
IsoRay also plays rope-a-dope with the five-year overall survival rate of 100% for Cesium-131 patients. The company fails to mention the comparable five-year survival rate for patients undergoing surgery alone is 98% -- a clinically meaningless difference of two percentage points. Moreover, the survival analysis is severely limited because nearly every patient in the study is censored, meaning they're lost to follow up. The study does not conclude that treatment with Cesium-131 leads to longer survival.
In their conclusion, the study authors do not endorse IsoRay's Cesium-131 or call the results "outstanding." They conclude that early-stage lung cancer patients may benefit from surgery plus Cesium-131 or an the alternative form of radiation therapy compared to surgery alone.
http://www.thestreet.com/story/13159992/1/isoray-takes-liberties-with-lung-cancer-study-results-to-prop-up-stock-price.html?puc=yahoo&cm_ven=YAHOO
NXTM: NxStage Reports First Quarter 2015 Financial Results And Exceeds Guidance
- Revenue Increases to $79.5 million, up 10% from Q1'14
- Home Revenue Increases to $43.5 million, up 19% from Q1'14
- Company Trending Toward Higher End of Annual Revenue Guidance Range
The company has been aggressively opening dialysis clinics featuring their NxStage System 1 machines. A smart way (in my opinion) to generate both product sales and ensure use of product. They continue to lose money, but the numbers suggest to me that they may break even in about 6 quarters, if they continue to generate the kind of outpatient ctr. revenue that they have to this point (and open some more centers.)
https://finance.yahoo.com/news/nxstage-reports-first-quarter-2015-115900938.html
NEO: LabCorp to buy Covance to enter clinical trials business
(Reuters) - Laboratory Corp of America Holdings , a major provider of healthcare diagnostic services, said it would buy Covance Inc for about $6.1 billion in cash and stock to expand into the contract clinical trial business.
LabCorp and larger rival Quest Diagnostics Inc have been under pressure due to cuts in reimbursement rates for certain diagnostic tests and fewer tests being ordered.
"For LabCorp, the last few years have been challenging with regards to volume and price perspective," Evercore ISI analyst Michael Cherny said. "And so to diversify away to a more pharma-related customer base will help mitigate some of those risks in the long term."
NEO has/had a deal to provide CVD with genetics testing services for clinical trials. During the last CC (last week), mgmt reported that they expected to start accruing revenue from this deal in the next quarter. It remains to be seen if there will be anything left from this deal after the acquisition has been completed, but I'm not optimistic. That said, the premium that Labcorp is paying indicates that the value of this business remains high and further, nixing this revenue stream does not impact NEO's continued 30% YOY growth in clinical services.
http://news.yahoo.com/labcorp-buy-covance-6-l-billion-112210379--finance.html
TTPH: Just a note (and damned if I posted about this a little while ago and didn't have the money to buy at the time.) Tetraphase Pharma is just about a double since my initial look and inquiry on this board.
TTPH- Thanks Peter. I value the opinions of board members, especially those who have been here and contributed to the content and discussion for years. Hope this will pique the interest of others as well.
AJ
TTPH"From the lack of response to your query, it sounds like the answer is no. Perhaps you could tell us more about why you like them."
Don't like the per se, but they showed up on my radar as I was doing some looking around. Given the evolution of drug resistant bacteria that have changed the game in health care, I am on the lookout for innovators in this space. That TTPH has a connection with Harvard Med School's office of technology development, appears to be well funded, and may have a technology platform that will allow the development of novel tetracycline and associated antibiotics all have piqued my interest. Read from the Harvard Office Of Technology's announcement regarding the partnership:
"TetraPhase's drug discovery and development efforts are based on fundamental technology developed by Professor Andrew Myers, Ph.D. and his colleagues in the Department of Chemistry and Chemical Biology at Harvard University. The Myers technology overcomes a key barrier to developing new tetracyclines by enabling for the first time their total synthesis from basic building blocks. Dr. Myers and his colleagues published the core synthesis technology in Science in April 2005.
Lawrence Miller, MD, Chairman of the Board, TetraPhase Pharmaceuticals and Partner at Mediphase Venture Partners, stated, "The emergence of drug-resistant bacteria, such as methicillin-resistant Staphylococcus aureus, is rapidly becoming a major public health challenge. There are few new drugs in development, particularly for community-based infections. With the Myers technology, associated Harvard patents and an experienced, core management team in place, TetraPhase is well positioned to develop a range of novel compounds based on this well-established class of antibiotics. Funding by this strong investor group is a significant endorsement of our approach."
Isaac T. Kohlberg, Senior Associate Provost and Chief Technology Development Officer, Harvard University, stated, "We believe that the ideal development pathway to the clinic for this technology is via a well-funded, professionally managed start-up company fully committed to its advancement. We are pleased that this investment group shares our confidence in the potential of TetraPhase and the Myers technology."
"This financing is the result of a strong and successful relationship with the Harvard Office of Technology Development and our joint commitment to build the framework for a sustainable company," continued Dr. Miller. "TetraPhase acquired the exclusive license to the Myers technology after collaboratively working with the OTD on a comprehensive technology development, finance and commercialization plan."
Tetracyclines are among the most commonly used classes of antibiotics and have proven safe and effective in more than 50 years of clinical use. Previously, all tetracyclines have been "semi-synthetic", that is, primarily synthesized by bacteria, purified, and modified for clinical use. However, the nature of this process markedly limits potential modifications, so that a narrow range of tetracyclines has been synthesized. As a result, only one new tetracycline has been approved in the past 30 years.
"After nearly 10 years of intensive research, my colleagues and I were able to make tetracyclines such as doxycycline, as well as tetracycline itself, from the simple starting material benzoic acid," said Dr. Myers. "We have begun to use this process to make new tetracyclines that were previously inaccessible by any means. Our discovery program has already yielded many novel tetracyclines, which in testing have demonstrated activity against a broad range of bacterial strains, including many resistant to traditional tetracycline antibiotics."
TetraPhase's senior management includes Louis Plamondon, Ph.D., Senior Vice President and Chief Scientific Officer, formerly of Millennium Pharmaceuticals; David Lubner, Senior Vice President and Chief Operating Officer, formerly of IMS Health/PharMetrics and ProScript; and Xiao-Yi Xiao, Ph.D., Vice President of Medicinal Chemistry, formerly of Miikana Therapeutics/Entremed. TetraPhase will be based in Watertown, MA."
http://www.techtransfer.harvard.edu/mediacenter/pr/release/20061124-01.php
This co. might be a one-trick pony (for now; their other candidates are in phase one research), and while the initial indications for Eravacycline may be limited, the need for a new generation of antibiotics is huge.
JM2C
AJ
TTPH Does anyone on the board follow Tetraphase Pharm (TTPH)? The Co. reports having a synthetic process for modifying tetracycline antibiotics that will provide new tetracycline-based antibiotics that will address multidrug resistant infections. They have one lead candidate in phase 3 trials at present. See the following:
https://clinicaltrials.gov/ct2/show/NCT01844856?term=Eravacycline&rank=1
From the TTPH website: We believe that our proprietary chemistry technology, licensed from Harvard on an exclusive worldwide basis and enhanced at Tetraphase, represents a significant innovation in the creation of tetracycline drugs and has the potential to reinvigorate the clinical and market potential of the class.
The tetracycline class of antibiotics has been used successfully for more than 50 years. Unlike our tetracycline compounds, all tetracyclines on the market and under development of which we are aware are produced semi-synthetically, first in bacteria and then modified in a limited number of ways by available chemistry. These conventional methods have only been able to produce tetracycline antibiotics with limited chemical diversity, making it difficult for conventional technology to create tetracycline antibiotics that address a wide variety of multi-drug resistant bacteria. In part, because of the challenges in creating novel tetracycline molecules, only one tetracycline antibiotic has been developed and approved by the FDA for sale in the United States in the past 30 years.
By contrast, our proprietary technology makes it possible to create novel tetracycline antibiotics using a practical, fully synthetic process for what we believe is the first time. This fully synthetic process avoids the limitations of bacterially derived tetracyclines and allows us to chemically modify many positions in the tetracycline scaffold, including most of the positions that we believe could not practically be modified by any previous method. Using our proprietary chemistry technology, we can create a wider variety of tetracycline-based compounds than was previously possible, enabling us to pursue novel tetracycline derivatives for the treatment of multi-drug resistant bacteria that are resistant to existing tetracyclines and other classes of antibiotic products.
The diagram below illustrates the tetracycline core scaffold. Scaffold positions marked with dots have been modified to date using conventional chemistry to create either tetracycline drugs that have been marketed or drug candidates of which we are aware that are currently in development. Our fully synthetic process also allows for modification of the positions marked with dots, but with greater opportunity for substitution than is possible using conventional chemistry. The scaffold positions marked with stars in the diagram below indicate useful positions that we have modified through our fully synthetic process that could not practically be modified by conventional chemistry.
NEO: The following is an investment profile released today by Hawk Associates on Neogenomics. Excuse me if I mislabel the profile, but I think this is called a "sell side" evaluation??
http://hawkassociates.com/pdf/profile/NEO.pdf
best,
aj
NEO -7% in AH session on stock offering:
I say, "Buying opportunity." Mgmt has been excellent on delivering and the float here is still quite small. I smell another acquisition or announcement of another lab opening.
NXTM: NxStage Reports Record Second Quarter 2014 Financial Results And Increases Full-Year Revenue Guidance
--Revenue Increases to $74.1 million, up 13% from Q2'13
--Home Revenue Increases to $38.5 million, up 18% from Q2'13
--Company Expects to Top 15% Annual Growth Target for Home in 2014
--Company Increases Full-Year 2014 Revenue Guidance to be between $290 and $293 million.
https://finance.yahoo.com/news/nxstage-reports-record-second-quarter-113800227.html
(This microcap renal dialysis equipment and services co. has now outperformed expectations for the third quarter in a row. It appears that their flagship product NxStage System One, a home hemodialysis system, continues to gain a foothold, with a healthy growth rate of adoption. The co. also runs several dialysis units, sells their NxStage systems to hospitals as their units are small and convenient to use. They need to show they can be profitable, but they are starting to become big enough to start showing up on radar screens as far as a buyout is concerned. Any co. with revenues closing in on $300 million with a market cap of under $1 billion and a relatively sound balance sheet is a target, IMO.)
What is the other one?
NXTM, the investment on a cost basis is about the same, but my expectations for NXTM is much more modest.
NEO: I was able to take a quick look at the metrics this morning before starting my clinical rounds. The company now looks to be vigorously growing despite the previously noted headwinds generated by the medicare changes in reimbursement. It looks like the co. is hitting on all cylinders and I would characterize today as their official "coming out party" for the market. The co. now is on many more radars for investment firms and I expect a progression of share acquisition to proceed.
This has been one of my two big biotech investments, and it is now looking like I picked a real winner. The next two years will be quite exciting, investment wise, if mgmt. can continue to innovate and gain market share.
best,
aj
NEO: NeoGenomics Completes Acquisition of Path Logic
(IMO, this is a great move and a perfect fit for NEO. Cost is nominal and benefits are many; read on)
FORT MYERS, Fla., July 8, 2014 /PRNewswire/ -- NeoGenomics, Inc. (NEO),a leading provider of cancer-focused genetic testing services, today announced that it has acquired Path Labs, LLC d/b/a Path Logic. Path Logic is a leading provider of specialized anatomic pathology services to Hospitals and physicians in Northern California. Path Logic provides high-quality Anatomic Pathology services with significant expertise in the sub-specialties of renal pathology, dermatopathology, women's health and gastrointestinal and genitourinary pathology.
For 2013, Path Logic reported revenue of approximately $10 million and employed approximately 65 people. The acquisition purchase price was $6.0 million. The transaction includes Path Logic's main laboratory in West Sacramento, California as well as satellite facilities in Santa Ana and Fresno California. Path Logic will operate as a wholly-owned subsidiary of NeoGenomics to provide specialized anatomic pathology services for NeoGenomics' clinical trials and pathology clients across the country.
Douglas M. VanOort, NeoGenomics Chairman and CEO, commented, "Path Logic has earned a reputation as one of the highest quality Anatomic Pathology Laboratories in California. The staff of outstanding specialized Pathologists, with capabilities in Dermatopathology, Nephropathology, Women's Health and GI/GU Pathology will further build and diversify NeoGenomics' specialized testing as a 'one-stop shop' for highly specialized AP testing services. With this expanded capability, both our clinical trial clients and our hospital and pathology-based clients will have access to an expanded product line and consulting expertise."
Mr. VanOort continued, "We estimate that $3-4 million of revenue synergies can be realized in relatively short order as a result of our existing customers and Path Logic's customers having access to each other's testing menus and capabilities. In addition, as redundant costs are eliminated during the remainder of this year, we expect the acquisition of Path Logic to be accretive to our earnings within six months."
https://finance.yahoo.com/news/neogenomics-completes-acquisition-path-logic-203700876.html
SPPI: This co. has NO credibility on the street! I am under water and am hoping that the eventual increase in revenue gets them closer to break even and then we will finally see some positive response. The short ratio is still huge, and there will just have to be some unwinding (I hope), if and when Beleodaq demonstrates that it has a market. Until then, I have nothing but my thing in MY HAND on this one :(
aj
SPPI: FDA Grants Spectrum Pharmaceuticals Accelerated Approval of Beleodaq™ (belinostat) for Injection.
• Early Action before PDUFA date of August 9, 2014 follows Priority Review
• Beleodaq to be launched through Spectrum's existing sales force
• Beleodaq is expected to be available to patients in less than 3 weeks
HENDERSON, Nev.--(BUSINESS WIRE)--
Spectrum Pharmaceuticals (SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted Accelerated Approval of Beleodaq™ for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on Tumor Response Rate and Duration of Response. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.
Beleodaq was approved by the FDA on July 3rd, nearly 5 weeks before the PDUFA date (August 9th). This indication was approved based on data from the multi-center, single-arm BELIEF trial in 120 evaluable patients, refractory to or who had failed at least one prior systemic therapy. In this trial, Beleodaq was associated with hematologic toxicity, infections, hepatotoxicity, tumor lysis syndrome, gastrointestinal toxicity, and embryo-fetal toxicity.
PTCL comprises a group of rare and aggressive non-Hodgkin’s Lymphomas (NHL) that develop from mature T-cells and accounts for approximately 10 to 15% of all NHL cases in the United States. These patients generally have a poor prognosis with a low response rate (25-27%) to available treatment options, and commonly experience repeated treatment failures until drug resistance or death. Therefore, there has been an important unmet medical need for these patients with PTCL for additional new treatment options that are specifically effective for this disease.
“This FDA approval enables us to help address this unmet medical need, and provide a new treatment option for patients with this difficult-to-treat and ultimately fatal disease,” said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. “First with Folotyn® (pralatrexate injection) and now with Beleodaq, we are very proud to be able to offer patients and clinicians two approved treatment options for R/R PTCL, and be a leader in the treatment of T-cell lymphomas. We will be able to effectively leverage our existing Hematology clinical and sales infrastructure to expedite the launch of Beleodaq. Now with a total of five approved Hematology/Oncology drugs and a strong and maturing development pipeline, Spectrum is well positioned for continued future growth.”
“Peripheral T-cell lymphoma (PTCL) is a poor prognosis subtype of non-Hodgkin's lymphoma with no accepted standard of care,” said Owen A. O'Connor, MD, PhD, Director of Lymphoid Malignancies, Professor of Medicine and Experimental Therapeutics at Columbia Medical Center, New York Presbyterian Medical Center, one of the lead investigators in the BELIEF study. “Relapse is common after initial treatment, and there are limited options for patients in 2nd line and beyond. Histone deacetylase inhibitors have emerged as one promising class of drugs for patients faced with this disease. One interesting observation in the study was the tolerability of Beleodaq in these heavily treated patients. Beleodaq was associated with myelosuppression with an overall rate of anemia of 32%, thrombocytopenia of 16.3% and neutropenia of 9.3% and Grade 3/4 adverse reactions were reported in 10.9%, 7.0% and 6.2% of patients, respectively. The associated severity of hematologic toxicities may prove to be useful in previously treated patients who have poor bone marrow reserve.”
“Interestingly, Beleodaq was shown to have an Overall Response Rate of 25.8% with a high response rate (45.5%) in patients with Angioimmunoblastic T-cell Lymphoma, one of the common PTCL subtypes. In addition, 17% of the patients enrolled in this trial had low Baseline platelet counts (3) and tolerated therapy with some (15%) attaining partial and complete responses. I believe Beleodaq will be a valuable new option for physicians who treat patients with relapsed or refractory PTCL. This safety profile makes it a potential candidate for the development of new combination treatment paradigms for patients with PTCL,” added Dr. O'Connor.
A review of data from a planned confirmatory Phase III trial of Beleodaq in combination with CHOP (cyclophosphamide, vincristine, doxorubicin, prednisone), to characterize the efficacy and safety of the Beleodaq combination versus CHOP alone, is required by FDA to convert this Accelerated Approval to a Full Approval.
BELIEF STUDY
The BELIEF study was an open-label, single-arm, non-randomized, international trial conducted at 62 centers that enrolled 129 patients with relapsed or refractory PTCL; 120 patients had histologically confirmed PTCL by central review and were evaluable for efficacy. Patients received treatment with Beleodaq (1,000 mg/m2), administered over 30 minutes via IV infusion, once daily on Days 1-5 of a 21-day cycle. Treatment cycles were repeated every three weeks until disease progression or unacceptable toxicity.
The primary efficacy endpoint of the BELIEF study was Overall Response Rate (complete and partial responses) as assessed by an Independent Review Committee (IRC) using the International Workshop Criteria (IWC) (Cheson, 2007). The key secondary efficacy endpoint was Duration of Response. In all evaluable patients (N = 120) treated with Beleodaq, the Overall Response Rate (CR + PR) per central review using IWC was 25.8% (n = 31; 95% CI, 18.3 – 34.6); with rates of 23.4% for PTCL, NOS and 45.5% for AITL, the two largest subtypes enrolled. The median Duration of Response based on the first date of response to disease progression or death was 8.4 months (95% CI: 4.5 - 29.4).
Data from the BELIEF study demonstrated that the most common adverse events (AEs) reported with Beleodaq (>25%) were nausea (42%), fatigue (37%), pyrexia (35%), anemia (32%), and vomiting (29%). Myelosuppression was observed with an overall rate of anemia of 32%, thrombocytopenia of 16.3% and neutropenia of 9.3%; Grade 3/4 adverse reactions were reported in 10.9%, 7.0% and 6.2% of patients, respectively. Sixty-one patients (47.3%) experienced serious adverse reactions while taking Beleodaq or within 30 days after their last dose of Beleodaq. The most common serious adverse reactions (>2%) were pneumonia (7%), pyrexia (5%), infection (3%), anemia (2%), increased creatinine (2%), thrombocytopenia (2%), and multi-organ failure (2%).
(I wonder if this will FINALLY shake this dog out of the doghouse)
aj
NEO: something might be up with Neogenomics. After settling around $3.20 this week, a flurry of big block trades sent it to $3.30 at the end of the day (2.5 million shares in all) and the after hours trading continued with another 2 million shares. I'm hoping that the news is a business development rather than a buyout, as this little baby has so much potential to grow.
Best to all,
aj
NEO: Can I have had worse timing???
News today (only if you dig for it and one of the longs on the YMB did) is that NEO is being removed from the Russell 3000 list when it is next updated. Seems to have placed downward pressure. A rare buying opportunity?
NEO: "Perhaps there is a new, undisclosed expense that offsets the increase in revenue."
Possibly, but I would doubt it, with the possible exception that they continue to add to their sales force. On face, the bump may swing 2-3 cents in the right direction, but for a co. at "break even" operations, why would they speculate what it will do when they can grab a better PR headline announcement when they actually crunch the numbers and report actual profits in July. Mgmt has had a good track record of under-promising and over-delivering, so my expectations are that this is the first of a series of good news events that will signify another leg up in the development of this co and the value will follow. Of interest to note, today's PR made no mention of the CVD alliance (which mgmt. has said will add to the revenue stream starting in the 2nd 1/2 of the year), so the growth was internal and organic, leaving any other business developments as ALSO good news.
I'm still a "big picture" investor here. I could give a rat's ass about profits so long as the revenue growth and business market share growth is healthy. The co. is still tiny (sub=$100 million/year in revenues) and they will not become a real player in the space unless/until they can triple their revenues. I've been invested since they were at $8 million/year, and they are now back to a 30% YOY target; healthy for any co.
It's been about 5 years since I had the conversation with Steve Jones (now VP of Finance and CCO but then CFO) and he told me that his philosophy was that any growth beyond 25% YOY and you ran the risk of "the wheels falling off" because things moved too fast, and his job was to make sure that this never happened to this co.
BTW, at a DCA of 70cents/share and an investment of 7 years, I am about at 5X my original investment just as the co. is at about 10X their sales when I bought them. My guess is that the share price will reflect closer to a $5-7/share value by the end of the year barring some new medicare snafu or major lab error that gets them bad press.
PS, sorry I missed your NXTM post of about a week ago; I finally took my family on that European trip that had been the dream for several years and promised to completely disconnect. Glad that another major investment had a bad news day and that I was blissfully unaware of it ;)
AJ
NEO: Beats on revenue and earnings (Modestly)
NeoGenomics Reports Record Revenue of $18.3 Million, Adjusted EBITDA of $2.7 Million and Net Income of $0.02 per Share for the Fourth Quarter 2013
http://finance.yahoo.com/news/neogenomics-reports-record-revenue-18-120000653.html
(Sorry for the lack of response to your last post Dew, I have been covered up with work and college campus visits. NEO has a high beta and the drop appeared to be part of the near market correction. Todays earnings report is, IMO, good but not great. I'll wait for the CC to hear how the CVD partnership is working out. Just an aside, ABT reduced their position in the co. from 4.9 million to 800K shares during the quarter.)
Question for DT: Last time we discussed this co. regarding their publication of a journal article regarding the MelanoSite Melanoma test, we determined that the journal was low tier and the publication was essentially meaningless. The co. announced that they have published an article regarding their genetic prostate Ca test in the journal Genetic Testing and Molecular Biomarkers , any opinions regarding the quality of this journal?
NEO: BRIEF-Neogenomics says received notice from affiliated oncology practices of termination of commercial deal, effective May 14 - filing
(Other side of the coin on NEO's business development. Mgmt had reported a trend in pathology labs terminating outsourcing contracts because of the TC grandfather sunset. This one appears to be a big termination, although the end of the contract is next May, with plenty of time to replace the business lost.)
Nov 18 (Reuters) - Neogenomics Inc : * On November 14th,co received notice from affiliated oncology practices of
termination of commercial deal between parties effective may 14, 2014 * Group comprised 15.8% of the company's revenue for the nine months ended
September 30, 2013 - SEC filing * Co understands that client intends to internalize many of tests that co has
been performing on client's behalf * Says is in ongoing discussions with this client to determine if a new
agreement can be reached on mutually acceptable terms * Source text for Eikon * Further company coverage
http://www.reuters.com/article/2013/11/18/neogenomics-brief-idUSWNAB035VR20131118
NEO: Covance Central Laboratories and NeoGenomics Enter into Exclusive Alliance to Provide Comprehensive Anatomic Pathology, Histology and Specialty Laboratory Testing Services for Clinical Trials
(As far as I can see, this is about as big or bigger than ABT taking a 10% stake in the co., the biggest news to date on co. development
PRINCETON, N.J. and FT. MYERS, Fla., Nov. 18, 2013 /PRNewswire-FirstCall/ -- Covance Inc. (CVD), one of the world's largest and most comprehensive drug development services companies, and NeoGenomics, Inc. (NEO), a leading provider of oncology-focused genetics testing services, today announced a strategic collaboration to jointly provide anatomic pathology and specialty laboratory testing services for global clinical trials.
Through the alliance, Covance's clients will gain access to fully integrated anatomic pathology and histology (APH) services, including immunohistochemistry (IHC), fluorescence in-situ hybridization (FISH), and molecular testing. Covance will establish a laboratory at NeoGenomics' Fort Myers, Fla. facility and, together with NeoGenomics, will provide a full range of APH, tissue-based biomarkers and other specialty testing services. The companies will then expand joint capabilities globally at Covance's central laboratory locations in Shanghai, China; Geneva, Switzerland; and Singapore.
As part of the alliance, Covance will have access to NeoGenomics' extensive medical and scientific networks, which includes more than 500 pathologists. NeoGenomics gains access to Covance's broad market reach, established client relationships, and extensive clinical trials experience. The alliance will provide seamless global testing services supporting oncology and companion diagnostics strategies for biopharmaceutical firms around the world.
"The collaboration with NeoGenomics will offer our clients fully integrated anatomic pathology services from sample preparation, staining and imaging, to pathology interpretation by leading pathologists, in an end-to-end manner," said Paul Kirchgraber, MD, Vice President of Laboratory Operations & Medical Affairs, Covance Central Laboratory Services. "Providing these integrated services through the Covance laboratory co-located within NeoGenomics results in improved turnaround times critical to oncology clinical trials."
Douglas VanOort, NeoGenomics Chairman and CEO, stated, "Our oncology-focused genetic and molecular testing services are a perfect complement to Covance's extensive laboratory services and will allow NeoGenomics to rapidly grow its clinical trials business with a world-class partner. We also look forward to the exciting opportunities that this collaboration will open up in the field of companion diagnostics."
http://finance.yahoo.com/news/covance-central-laboratories-neogenomics-enter-120000296.html
NEO: Are NEO's non-reimbursed customers actually paying their bills?
Busy day in clinic. I will not be able to listen to the CC until this evening. If they say something substantive about this, I will post back,
aj
NEO: NeoGenomics Reports Record Revenue of $16.9 Million, Adjusted EBITDA of $2.2 Million and Net Income of $900K for the Third Quarter 2013
FT. MYERS, Fla., Oct. 23, 2013 /PRNewswire/ -- NeoGenomics, Inc. (NEO), a leading provider of cancer-focused genetic testing services today reported its results for the third quarter of 2013.
Third Quarter 2013 Highlights:
•Revenue growth of 18.9%
•Test volume growth of 19.1%
•Gross Profit Margin of 48.4% versus 41.5% last year
•Adjusted EBITDA(1) growth of 157%
•Net Income of $0.02 per share versus a loss of $0.02 last year
Revenue for the third quarter was $16.9 million, an 18.9% increase from third quarter 2012 revenue.Test volume increased by 19.1% year over year, while average revenue per test was largely unchanged. Average cost of goods sold per test declined by 12% as a result of continued productivity improvements, increased leverage from higher volumes, and other cost containment initiatives. As a result, gross profit increased by 38.7% from the prior year.
Total operating expenses increased by 6.6% from last year's third quarter, primarily as a result of additional sales representatives and increases in billing and information technology expenses. This was partially offset by a decrease in stock compensation expenses related to the decline in the Company's stock price for the quarter.
Net income for the quarter was $900,000, or $0.02 per share, versus a net loss of $(975,000), or $(0.02) per share, in last year's third quarter. Adjusted EBITDA(1) improved by 157% to $2.2 million for the quarter from $842,000 last year.
Douglas M. VanOort, the Company's Chairman and CEO commented, "We are pleased with our third quarter results. Solid growth in test volume was driven by continued success with new products and growth in the number of customer accounts. The productivity of our sales team improved with gains in all geographic territories across the country. In addition, we have added five sales representatives and two product managers since the end of the second quarter to further accelerate growth."
Mr. VanOort continued, "We continued to improve productivity and increase our efficiency and effectiveness during the quarter. As a result, we realized strong reductions in average cost-per-test, which allowed us to drive 85% of the incremental $2.7 million of revenue to gross profit. We are in the process of redesigning and expanding our Fort Myers, Florida laboratory to incorporate lean workflow concepts and improved automation. We expect this new lab to be complete in the first quarter of 2014 and believe it will yield further process improvements."
Mr. VanOort added, "As a result of our strategic focus on innovation and new product development, NeoGenomics is increasingly being recognized as a leader in cancer testing in this era of 'precision medicine'. We have now introduced over 30 new Molecular tests and profiles to our menu since the beginning of 2013 and we expect to launch several more tests and next generation sequencing for clinical use by early 2014. We believe we now have the broadest oncology-focused clinical testing menu in the country, and we are beginning to see increasing interest in our comprehensive genetic capabilities from the pharmaceutical industry."
Fourth Quarter and Full-Year 2013 Financial Outlook:
We expect revenue of $17.6-$18.1 million and earnings of $0.01 to $0.02 per share in Quarter 4. For the full year 2013, we expect revenue to be $65.7-$66.2 million with earnings per share of $0.03 to $0.04. The Company reserves the right to adjust this guidance at any time based on the ongoing execution of its business plan. Current and prospective investors are encouraged to perform their own due diligence before buying or selling any of the Company's securities, and are reminded that the foregoing estimates should not be construed as a guarantee of future performance.
____________________
(1) Adjusted EBITDA is defined as earnings before interest, taxes, depreciation, amortization, non-recurring moving expense for the move of our facility in Irvine, California in 2012, and non-cash stock-based compensation expenses. See table for a reconciliation to net income.
Conference Call
The Company has scheduled a web-cast and conference call to discuss their Q3 2013 results on Wednesday October 23, 2013 at 11:00 AM EDT. Interested investors should dial (877) 407-8035 (domestic) and (201) 689-8035 (international) at least five minutes prior to the call and ask for Conference ID Number 10000554. A replay of the conference call will be available until 11:59 PM on November 6, 2013 and can be accessed by dialing (877) 660-6853 (domestic) and (201) 612-7415 (international). The playback conference ID Number is 10000554. The web-cast may be accessed under the Investor Relations section of our website at www.neogenomics.com or http://www.investorcalendar.com/IC/CEPage.asp?ID=171755. An archive of the web-cast will be available until 11:59 PM on January 23, 2014.
http://finance.yahoo.com/news/neogenomics-reports-record-revenue-16-110000982.html