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In CYBR @ $48.75 on fall this morning. Not long at this point, but great sector to be in and highly rated:
Consensus Ratings for Cyberark Software Ltd (NASDAQ:CYBR)
Ratings Breakdown: 1 Sell Rating, 4 Hold Ratings, 16 Buy Ratings
Consensus Rating: Buy (Score: 2.71)
Consensus Price Target: $58.50 (6.07% upside)
https://www.marketbeat.com/stocks/NASDAQ/CYBR/
CYBR
Eiger BioPharmaceuticals Reports First Quarter 2017 Financial Results
By PR Newswire, May 12, 2017, 08:00:00 AM EDT
- Five Phase 2 Programs in Four Orphan Indications Progressing
- Multiple Clinical and Regulatory Milestones Expected 2017-2018
PALO ALTO, Calif., May 12, 2017 /PRNewswire/ --
Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for rare diseases, announced today financial results for the three months ended March 31, 2017 and provided a business update.
"Building on our achievements in 2016, we have continued to execute on all programs in 2017, and we are anticipating multiple key clinical and regulatory milestones later in 2017 and 2018," said David Cory, President and CEO of Eiger BioPharmaceuticals. "We are especially excited about the recently presented results of our Phase 2 program with lonafarnib in hepatitis delta virus (HDV) infection, and look forward to continued discussions with the FDA and other regulatory agencies regarding next steps in development. In parallel, we have made significant progress advancing the Phase 2 clinical development of exendin 9-39 for post-bariatric hypoglycemia and ubenimex for pulmonary arterial hypertension and lymphedema, underscoring the diversity and therapeutic differentiation of our development pipeline and potential for multiple value-creating events in the coming months."
Key Achievements to Date in 2017
Lonafarnib in HDV
Key results from the Phase 2 LOWR HDV (LOnafarnib With Ritonavir in HDV) program presentations at The International Liver Congress™ in April:
All-Oral LNF 25 mg or 50 mg BID + RTV suppresses HDV-RNA at end of treatment
5 of 14 (36%) HDV-RNA < LOQ (limit of quantitation by qPCR) at Week 24
Addition of PEG IFN to LNF 25 mg BID + RTV results in highest response rates
4 of 5 (80%) HDV-RNA < LOQ at Week 24
3 of 5 (60%) PCR-negative at Week 24
Low-level viremia off-therapy
2 of 2 PCR-negative at 24 weeks post-treatment
60-78% of patients normalized ALT at Week 24
Adverse events (AEs) predominately mild / moderate for LNF 25 / 50 mg regimens
Interferon Lambda in HDV
First patient dosed in international Phase 2 LIMT HDV study (Lambda Interferon Monotherapy Trial in HDV)
U.S. IND filed and approved; opportunity to include clinical sites in the U.S.
Exendin 9-39 in Post-Bariatric Hypoglycemia (PBH)
Lisa Porter, M.D., appointed to lead clinical development
Proprietary liquid formulation developed for subcutaneous injection
Clinical evaluation of liquid formulation in Phase 2 multiple ascending dose (MAD) study and Phase 1 PK study
Ubenimex in Pulmonary Arterial Hypertension (PAH)
Phase 2 LIBERTY study completed enrollment
PAH KOL analyst event - May 10
Ubenimex in Lymphedema
Phase 2 ULTRA international study enrolling
Publication of preclinical results in Science Translational Medicine
Strong Balance Sheet
Expenses on track; cash runway extends through mid-2018
Anticipated Milestones in 2017 and early 2018
Lonafarnib HDV program: FDA meeting planned in the fourth quarter
Lambda in HDV: interim data from LIMT HDV study in the fourth quarter at AASLD
Exendin 9-39 in PBH: completion of MAD study in second quarter 2017 with data to be presented at ADA meeting in June 2017, completion of PK study with novel liquid formulation in the third quarter, and initiation of Phase 2 - 28-day study in the fourth quarter of 2017 with data in the first half of 2018
Ubenimex in PAH: Phase 2 LIBERTY data anticipated in first quarter 2018 at JPM
Ubenimex in Lymphedema: complete ULTRA enrollment in fourth quarter 2017; data anticipated in second quarter 2018.
First Quarter 2017 Financial Results
Net loss for the first quarter of 2017 was $11.2 million, or $1.34 per share basic and diluted, compared to a net loss of $9.7 million, or $10.42 per share basic and diluted for the first quarter of 2016.
Research and development expenses for the first quarter of 2017 were $7.4 million compared to $4.8 million for the first quarter of 2016, an increase of $2.6 million. The increase was primarily due to a $1.6 million increase in clinical expenditures coupled with a $0.9 million increase in compensation and personnel related expenses due to an increase in headcount.
General and Administrative expenses for the first quarter of 2017 were $3.5 million compared to $3.8 million for the first quarter of 2016, a $0.3 million decrease. The decrease was primarily due to a $1.9 million decrease in legal, consulting, advisory and accounting services incurred related to the Merger in the first quarter 2016. The decrease was partially offset by a $0.9 million increase in stock-based compensation expense.
As of March 31, 2017, Eiger had cash, cash equivalents and short term marketable securities of $49.0 million, compared to $59.9 million at December 31, 2016.
About Eiger
Eiger is a clinical-stage biopharmaceutical company committed to bringing to market novel products for the treatment of rare diseases. The company has built a diverse portfolio of well-characterized product candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which an effective therapy is urgently needed. For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives, intentions, beliefs and expectations of management are forward-looking statements. These forward- looking statements may be accompanied by such words as "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "project," "target," "will" and other words and terms of similar meaning. Examples of such statements include, but are not limited to, our ability to timely and successfully achieve, all or any of the anticipated 2017 and 2018 milestones, whether or not pegylated interferon lambda or lonafarnib or ubenimex or exendin 9-39 may be further developed and approved, statements relating to the availability of cash for Eiger's future operations and drug development portfolio, Eiger's ability to develop its drug candidates for potential commercialization, the timing of the commencement and number and completion of Phase 2 trials and whether the products can be successfully developed or commercialized. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Eiger makes, including the risks described in the "Risk Factors" sections in the Annual Report on Form 10-K for the period ended December 31, 2016 and Eiger's periodic reports filed with the SEC. Eiger does not assume any obligation to update any forward-looking statements, except as required by law.
Investors:
Jim Welch, Eiger BioPharmaceuticals, 650-279-9845, jwelch@eigerbio.com
Eiger BioPharmaceuticals Inc.
Selected Statements of Operations Financial Data
(in thousands, except share and per share amounts)
(unaudited)
(Details omitted)
http://www.nasdaq.com/press-release/eiger-biopharmaceuticals-reports-first-quarter-2017-financial-results-20170512-00331
EIGR
Was quite a day for what I assume is a pretty quiet stock, from the Cowen downgrade to the China report and the CEO resignation at the end. Market seems to like the resignation.
Personally going to watch before re-entering. You in?
BMY
Bounce came @ approx 1:30. Can't find a reason other than the article about China cut in production:
http://www.scmp.com/business/commodities/article/2093844/china-serious-slashing-steel-capacity-excess-production-still
I sold @ $21.35 as had been seriously down due to the Cowen downgrade.
Will be back as there is more up here but wanted to protect the gains today.
X
Roche's Loss In Bladder Cancer Lifts Astrazeneca and Could Boost Bristol-Myers
James Skinner James Skinner Follow May 10, 2017 5:50 AM EDT
Roche said that Tecentriq did not meet its primary endpoint of demonstrating overall survival in bladder cancer patients when the treatment is compared with chemotherapy in a statement that could provide rival Astrazeneca (AZN) with scope to close the gap between them, as well as a possible boost for Bristol-Myers Squibb (BMY) stock in Wednesday trading.
Roche shares were marked 2.27% lower by late morning in Zurich and changing hands at Sfr 266.5 each against an 0.89% gain of the Stoxx Europe 600 TMI Pharmaceuticals index. AstraZeneca shares were little-changed from their Tuesday close and trading at 4,712 pence each at 10:30 BST in London. Bristol-Myers were indicated 0.56% lower in premarket trading after closing at $55.32 each in New York Tuesday.
Roche secured accelerated approval for Tecentriq in April based on the drug's strong performance combatting tumours, in a move that could have helped the drugmaker to close the gap with Bristol-Myers whose Opdivo won approval back in January.
______________________________________________________
https://www.thestreet.com/story/14127926/2/roche-s-loss-in-bladder-cancer-lifts-astrazeneca-and-could-boost-bristol-myers.html
BMY
Suppose this shouldn't have impact on BMY, but FWIW:
Eight Democratic senators ask regulators to probe Icahn, Reuters tweets Reuters tweets that "Eight Democratic senators ask regulators to probe Carl Icahn over biofuels credit market activity. Senators say probe should examine whether Icahn violated 'insider trading, anti-market manipulation laws'." Reference Link
Read more at:
https://thefly.com/landingPageNews.php?id=2549419
BMY
JPMorgan Has 3 Top Pick Large Cap Pharmaceuticals to Buy for the Rest of 2017
By Lee Jackson May 5, 2017 8:20 am EDT
One segment in the markets that has been dogged with issues for almost two years is the big pharmaceuticals, as numerous factors have kept the lid on share prices and, in some cases, kept the headlines right in investors’ faces. The biggest issue is the seemingly constant and somewhat shrill rhetoric from attention-seeking politicians over drug prices. While that may play well with constituents, it can be difficult for companies trying to deliver for shareholders.
In a new research report, the outstanding team at JPMorgan make the case that the best place for investors to look when considering large cap drug stocks is companies that have strong new product cycles already in motion. They also focus on stocks with attractive top-line and margin expansion potential. Three make the grade, and are all rated Overweight.
Bristol-Myers Squibb
This top company remains a favorite at Jefferies and ranks as the fourth top global pick. Bristol-Myers Squibb Co. (NYSE: BMY) is a global pharmaceutical company focused on discovering, developing, licensing and marketing chemically synthesized drugs or small molecules and biologics in various therapeutic areas, including virology comprising human immunodeficiency virus infection (HIV), oncology, neuroscience, immunoscience and cardiovascular.
The company recently announced that Biogen will pay $300 million upfront to Bristol-Myers to license a palsy drug with a $2 billion market opportunity and the potential to use that to treat Alzheimer’s. The company will pay a total of $410 million in milestone payments and a tiered double-digit royalty to license a drug known only as BMS-986168. The drug just completed Phase 1 testing in progressive supranuclear palsy.
The company reported first-quarter profit and revenue that exceeded Wall Street expectations. The results included a 60% increase in global revenues for cancer drug Opdivo, compared with the year-earlier period,
Shareholders receive a 2.83% dividend. JPMorgan has a $66 price objective, and the consensus target price is $56.33. The shares closed on Thursday at $55.19.
(other 2 stocks omitted)
_______________________________________________________
http://247wallst.com/healthcare-business/2017/05/05/jpmorgan-has-3-top-pick-large-cap-pharmaceuticals-to-buy-for-the-rest-of-2017/
BMY
You must be referencing the SA article from yesterday < https://seekingalpha.com/article/4068716-bristol-myers-squibb-dividend-cut-inevitable >. Note, however, SA also had an article on May 1 suggesting they might raise the dividend < https://seekingalpha.com/article/4067638-bristol-myers-squibb-strong-earnings-warrant-higher-dividend-growth-ahead?li_source=LI&li_medium=liftigniter-widget >. Take your pick -- the latter author has about 10,000 more followers although I suppose that shouldn't be the only basis for deciding. Also, read the comments about the article from yesterday.
My personal initial reaction upon hearing the quarterly was humm, maybe a dividend increase.
BMY
Looks like the November gap filled:
11/09/2016 24.41 25.08 23.86 24.56 41,307,770
11/08/2016 20.49 21.39 20.26 20.96 19,544,980
Read more: http://www.nasdaq.com/symbol/x/historical#ixzz4g21kfh2h
X
Eiger Announces U.S. IND Filing of Pegylated Interferon Lambda for Hepatitis Delta Virus Infection
PALO ALTO, Calif., May 3, 2017 /PRNewswire/ --
Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for rare diseases, announced today that the U.S. IND has been filed for Pegylated Interferon Lambda in the treatment of hepatitis delta virus (HDV) infection. U.S. sites are planned for the ongoing Phase 2 LIMT HDV (Lambda Interferon MonoTherapy in HDV) study, a monotherapy trial of pegylated interferon lambda 1a ("Lambda") as a potential treatment for chronic hepatitis D virus (HDV) infection.
Eiger BioPharmaceuticals (PRNewsFoto/Eiger BioPharmaceuticals, Inc.)
"Filing the U.S. IND for Lambda in the treatment of HDV is a strategic imperative for Eiger," said Shelly Xiong, PhD, RAC, Senior Vice President of Regulatory Affairs at Eiger. "This filing should facilitate discussions with the agency regarding potential Lambda development and registration pathways for HDV as well as expanding the program to U.S. investigators and U.S. patients."
"Over recent years, patients with chronic hepatitis B and hepatitis C have benefited from huge advances in antiviral therapy for both diseases. Unfortunately HDV remains a large unmet medical need because of the lack of any effective therapy for this most aggressive form of viral hepatitis. In many countries, HDV presents a real public health challenge," said Eduardo Martins, MD, DPhil, Senior Vice President of Liver and Infectious Diseases Development at Eiger. "We look forward to expanding our HDV development program to include Lambda monotherapy and potential combinations, including lonafarnib."
About the LIMT HDV Phase 2 Study
LIMT HDV is a 1:1 randomized, open-label study of Lambda 120 or 180 microgram subcutaneous injections administered weekly for 48 weeks in approximately 30-40 patients with chronic HDV. End of treatment will be followed by a treatment-free 24-week observation period. The primary objective of the phase 2 study is to evaluate the safety, tolerability, and efficacy of treatment with two dose levels of Lambda monotherapy in patients with chronic HDV infection. All patients will also be administered an anti-hepatitis B virus nucleos(t)ide analog throughout the study. LIMT HDV is an international study currently enrolling at sites in New Zealand, Israel and Pakistan.
About Pegylated Interferon Lambda 1a
Pegylated interferon lambda 1a ("Lambda") is a well-characterized, late-stage, first in class, type III interferon (IFN) that stimulates immune responses that are critical for the development of host protection during viral infections. Lambda targets type III IFN receptors which are distinct from the type I IFN receptors targeted by IFN alfa. These type III receptors are highly expressed on hepatocytes with limited expression on hematopoietic and central nervous system cells, which may reduce the off-target effects associated with other IFNs and improve the tolerability of Lambda. Although Lambda does not use the IFN alfa receptor, signaling through either the IFN lambda or IFN alfa receptor complexes results in the activation of the same Jak-STAT signal transduction cascade.
Eiger licensed worldwide rights to Lambda from Bristol-Myers Squibb in April 2016. Lambda has been administered in HBV / HCV clinical trials involving over 3,000 subjects. Lambda has not been approved for any indication.
About Hepatitis Delta Virus (HDV)
Hepatitis Delta (or Hepatitis D) is caused by infection with HDV and is considered to be one of the most severe forms of viral hepatitis in humans. Hepatitis delta occurs only as a co-infection in individuals harboring Hepatitis B Virus (HBV). Hepatitis delta leads to more severe liver disease than HBV alone and is associated with accelerated liver fibrosis, liver cancer, and liver failure. Hepatitis delta is a disease with a significant impact on global health, which may affect up to approximately 15-20 million people worldwide. The prevalence of HDV varies among different parts of the world. Globally, HDV infection is reported to be present in approximately 4.3% to 5.7% of chronic Hepatitis B carriers. The prevalence of HDV in patients infected with chronic HBV is even higher in certain regions, including certain parts of Mongolia, China, Russia, Central Asia, Pakistan, Turkey, Africa, and South America, with an HDV prevalence as high as 60% being reported in HBV-infected patients in Mongolia and Pakistan.
About Eiger
Eiger is a clinical-stage biopharmaceutical company committed to bringing to market novel products for the treatment of rare diseases. The company has built a diverse portfolio of well-characterized product candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which an effective therapy is urgently needed.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives, intentions, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "project," "target," "will" and other words and terms of similar meaning. Examples of such statements include, but are not limited to, whether or not pegylated interferon lambda-1a or lonafarnib or ubenimex or exendin 9-39 may be further developed and approved, statements relating to the availability of cash for Eiger's future operations, Eiger's ability to develop its drug candidates for potential commercialization, the timing of the commencement and number and completion of Phase 2 trials and whether the products can be successfully developed or commercialized. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Eiger makes, including the risks described in the "Risk Factors" sections in the Annual Report on Form 10-K for the period ended December 31, 2016 and Eiger's periodic reports filed with the SEC. Eiger does not assume any obligation to update any forward-looking statements, except as required by law.
Investors: Ingrid Choong PhD, Eiger BioPharmaceuticals, 650-619-6115, ichoong@eigerbio.com
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/eiger-announces-us-ind-filing-of-pegylated-interferon-lambda-for-hepatitis-delta-virus-infection-300450390.html
SOURCE Eiger BioPharmaceuticals, Inc.
Copyright 2017 PR Newswire
__________________________________________
EIGR
They live up to their ugly reputation. They wanted to insure their salaries for the next year or so. Hopefully, those folks who bought Friday above $3.10 will sue.
Having followed AEZS for years it signaled to me that they were about to announce a failure otherwise the ATM would have been after the results at a level where they could have leveraged more.
AEZS
I'll leave it to the analysts who have it at ~$62.00. Nasaq has a $62 target as does MarketBeat, probably due to an overlap of analysts:
Consensus Ratings for Bristol-Myers Squibb Co (NYSE:BMY)
Ratings Breakdown: 11 Hold Ratings, 9 Buy Ratings
Consensus Rating: Hold (Score: 2.45)
Consensus Price Target: $62.35 (11.44% upside)
https://www.marketbeat.com/stocks/NYSE/BMY/
Eyeballing a 3 year chart looks to me to be low to mid $60's. Pretty crude but they jibe:
I don't see an imminent buyout despite the informational posts regarding such speculation.
What is your take?
BMY
Rumors persist:
____________________________________________________
Is Pfizer really weighing a BMS buy? Clues from Q1's earnings call say it just may be
by Carly Helfand | May 2, 2017 11:35am
Pfizer CEO Ian Read told investors on Tuesday that he thinks the company has the ability to swallow a large deal if the right opportunity arises.
Is Pfizer thinking of buying Bristol-Myers Squibb, as the rumors go? CEO Ian Read hinted at the possibility on Tuesday's first-quarter earnings call—but investors shouldn’t expect any immediate action, he cautioned.
As Read told shareholders on the call, “we … believe we have the ability, should the opportunity arise and should the value be there, to do a large deal.”
He noted, though, that “certain large companies have significant, almost binary risks … which could immediately alter their values,” which is one reason the company won’t be rushing into anything.
Bristol-Myers, whose status in the immuno-oncology field was compromised last year by a flopped first-line immonotherapy trial in non-small cell lung cancer, certainly fits that bill. Its lung cancer hopes are now resting on a combo of PD-1 med Opdivo and a CTLA-4 drug—an approach that’s not shared by Merck's rival Keytruda and Roche's Tecentriq, which are going after checkpoint inhibitor/chemo pairings.
With that in mind, snatching up BMS wouldn’t make a lot of sense for Pfizer “until more clarity is gained on how the battle will shake out between ‘CTLA4 combo’ and ‘chemo combo,’" Bernstein analyst Tim Anderson has written to clients, noting that “having the value of the target change materially for the worse could make management look bad.”
Bristol-Myers’ struggles first ignited merger rumors early this year, and the ever-deal-seeking Pfizer was quick to see its name pop up as a potential buyer. One reason? Despite its partnership with Merck KGaA on avelumab—which recently picked up its first approval, a Merkel cell carcinoma nod, under the brand name Bavencio—analysts say the New York pharma is not necessarily a lock to be a leader in the so-called second wave of immuno-oncology drugmakers.
Read, though, insisted on Tuesday that Pfizer is “committed” to the partnership and remains “focused on developing avelumab”—though he also acknowledged that backing out of the deal wouldn't be a megadealbreaker.
“I don’t think that any type of breakup fee would be material compared to the size of a large deal,” he said, suggesting a potential BMS buy would trump walking out on Merck.
Questions surrounding the combo approach aren’t the only factor holding up Pfizer’s dealmaking activity, though. Read listed uncertainty around U.S. tax reform and even the French election as reasons to stay put for now—a stark contrast to the company’s last earnings call, on which the Pfizer chief insisted it would “continue to do BD where we see value for our shareholders” instead of taking a “dramatic pause” to wait and see “what the tax code’s going to do.”
The way Goldman Sachs analyst Jami Rubin sees things, that business development is all the more important in light of Pfizer’s first-quarter performance, which saw some key meds fall short of estimates. In a note to clients, she pointed in particular to Xtandi, whose $131 million in sales is “clearly weak given [Pfizer] paid $14 billion for this asset,” and Xeljanz, which came in $38 million behind consensus, writing that the misses raised “concerns about Pfizer’s ability to grown in the absence of M&A in our view.”
Pfizer, for its part, attributed part of the revenue miss to a selling period slightly shorter than last year’s, which it said took $300 million off its $12.79 billion revenue tally. And despite the time crunch, it was able to best forecasts with breast cancer-fighter Ibrance, which raked in $679 million to edge Wall Street’s $672 million prediction.
All eyes are on that drug now that Novartis is out with rival Kisqali, which undercut Ibrance on price. Pfizer’s innovative health president Albert Bourla, though, reminded investors on the call that the company had successfully “managed … price competition in the past, and we will do it in the future.”
Meanwhile, the company managed a beat on the earnings front thanks to lower expenses and a gain on divestments, reporting per-share profits of 69 cents that topped the 67-cent consensus estimate. It also reaffirmed its 2017 guidance, and “and we continue to maintain the numbers are well within reach,” Barclays analyst Geoff Meacham wrote in an investor note.
________________________________________________________
http://www.fiercepharma.com/pharma/pfizer-really-weighing-a-bms-buy-clues-from-q1-s-earnings-call-say-it-just-may-be
BMY
Out LBY @ eod @ $10.71. Didn't want to be in on earnings. Could be pleasant surprise -- or not.
LBY
Speculation prior to PFE earnings:
_________________________________________
M&A SPECULATION: This past February, whispers surrounding rival drug maker Bristol-Myers (BMY) being a takeover target began to circulate. Pfizer along with Roche (RHHBY), Novartis (NVS) were mentioned as possible suitors. At the time, Deutsche Bank analyst Gregg Gilbert said he would be surprised to see Pfizer make a move on Bristol-Myers Squibb at this stage. Such an acquisition "would represent a very large and concentrated opportunity/risk on immuno-oncology, an area fraught with near-term uncertainty," Gilbert told investors in a research note from February. In late March, Credit Suisse analyst Vamil Divan revisited the hypothetical sale of Bristol-Myers Squibb, arguing that an acquisition by Pfizer could be net positive for the company. The analyst, who reminded investors that he called a Bristol takeout "unlikely" in a March 5 note, says the concept remains "one of the most common topics of discussion in our investor meetings" in light of the drugmaker's ongoing challenges and activist targeting. Divan said his colleagues at Credit Suisse's "HOLT" proprietary valuation group have now analyzed a potential Pfizer-Bristol deal and concluded that it would have a "positive impact" on the company's return on capital profile.
___________________________________________________
Read more at:
http://thefly.com/landingPageNews.php?id=2543237
BMY
Conference Call May 1, 2017 @ 8:30 am ET: Aeterna Zentaris to Announce top-line results of the ZoptEC Phase 3 Clinical Study of Zoptrex™
From:
Monday, May 1, 2017 8:30 am EDT (7:30 am CDT, 6:30 am MDT, 5:30 am PDT)
To:
Monday, May 1, 2017 9:30 am EDT (8:30 am CDT, 7:30 am MDT, 6:30 am PDT)
Duration: 1 Hour
The Company will host a conference call to discuss the results of the ZoptEC Phase 3 clinical study of Zoptrex™ on Monday, May 1, 2017, at 8:30 AM, Eastern Time.
Participants may access the conference call by using the following number: 201-689-8029, Confirmation 13660857.
More good news. pps should be flying:
________________________________________________________
European Commission Approves Bristol-Myers Squibb’s Opdivo (nivolumab) for Squamous Cell Cancer of the Head and Neck in Adults Progressing On or After Platinum-based Therapy
Business Wire Business WireApril 28, 2017
PRINCETON, N.J.--(BUSINESS WIRE)--
Bristol-Myers Squibb Company (BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) as monotherapy for the treatment of squamous cell cancer of the head and neck (SCCHN) in adults progressing on or after platinum-based therapy. Opdivo is the first and only Immuno-Oncology (I-O) treatment that demonstrated in a Phase 3 trial a significant improvement in overall survival (OS) for these patients.
“Adult patients with squamous cell cancer of the head and neck that progresses on or after platinum-based therapy are fighting a debilitating and hard-to-treat disease that is associated with a very poor prognosis,” said Kevin Harrington, M.D., Ph.D., professor in Biological Cancer Therapies at The Institute of Cancer Research, London, and a consultant clinical oncologist at The Royal Marsden NHS Foundation Trust in London. “As an oncologist who helps patients deal with this terrible disease, I hope that nivolumab will now be made available as widely as possible, offering this group of patients a new treatment option that can potentially improve their overall survival."
The approval was based on results from CheckMate -141, a global Phase 3, open-label, randomized trial, first published in The New England Journal of Medicine last October, which evaluated Opdivo versus investigator’s choice of therapy in patients aged 18 years and above with recurrent or metastatic, platinum-refractory SCCHN who had tumor progression during or within six months of receiving platinum-based therapy administered in the adjuvant, neo-adjuvant, primary or metastatic setting. Investigator’s choice of therapy included methotrexate, docetaxel, or cetuximab. The primary endpoint was OS. The trial’s secondary endpoints included progression-free survival (PFS) and objective response rate (ORR).
“The European Commission’s approval of Opdivo marks not only the first new treatment option in 10 years for patients with advanced cancers of the head and neck, but also the first Immuno-Oncology treatment for SCCHN,” said Murdo Gordon, executive vice president and chief commercial officer, Bristol-Myers Squibb. “Bristol-Myers Squibb remains committed to redefining survival for patients with cancer, and now that Opdivo is approved in Europe, we will work collaboratively with EU health authorities to ensure it is available for these patients as quickly as possible.”
In the interim analysis of the pivotal trial, Opdivo demonstrated statistically significant improvement in OS with a 30% reduction in the risk of death (HR=0.70 [95% CI: 0.53-0.92; p=0.0101]), and a median OS of 7.5 months (95% CI: 5.5-9.1) for Opdivo compared with 5.1 months (95% CI: 4.0-6.0) for the investigator’s choice arm. There were no statistically significant differences between the two arms for PFS (HR=0.89; 95% CI: 0.70, 1.13) or ORR (13.3% [95% CI: 9.3, 18.3] vs 5.8% [95% CI: 2.4, 11.6] for Opdivo and investigator’s choice, respectively. The EC approval was based on updated study results, which will be presented at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO).
Patient reported outcomes (PROs) were evaluated using the following European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Assessment: EORTC QLQ-C30, EORTC QLQ-H&N35, and 3-level EQ-5D instruments. Patients treated with Opdivo exhibited stable PROs, while those assigned to investigator’s choice therapy exhibited significant declines in functioning (e.g., physical, role, social) and health status as well as increased symptomatology (e.g., fatigue, dyspnoea, appetite loss, pain and sensory problems).
The safety profile of Opdivo in CheckMate -141 was consistent with prior studies in patients with melanoma and non-small cell lung cancer. Serious adverse reactions occurred in 49% of patients receiving Opdivo. The most frequent serious adverse reactions reported in at least 2% of patients receiving Opdivo were pneumonia, dyspnea, aspiration pneumonia, respiratory failure, respiratory tract infection, and sepsis.
About Head & Neck Cancer
Cancers that are known as head and neck cancers usually begin in the squamous cells that line the moist mucosal surfaces inside the head and neck, such as inside the mouth, the nose and the throat. Head and neck cancer is the seventh most common cancer globally, with an estimated 400,000 to 600,000 new cases per year and 223,000 to 300,000 deaths per year. The five-year survival rate is reported as less than 4% for metastatic Stage IV disease. Squamous cell cancer of the head and neck (SCCHN) accounts for approximately 90% of all head and neck cancers with global incidence expected to increase by 17% between 2012 and 2022. Risk factors for SCCHN include tobacco and alcohol consumption. Human Papilloma Virus (HPV) infection is also a risk factor leading to rapid increase in oropharyngeal SCCHN in Europe and North America.
About Opdivo
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.
Opdivo’s leading global development program is based on Bristol-Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has enrolled more than 25,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression. In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 60 countries, including the United States, the European Union and Japan. In October 2015, the company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.
U. S. FDA APPROVED INDICATIONS FOR OPDIVO®
OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.
OPDIVO® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
OPDIVO® (nivolumab) is indicated for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.
OPDIVO® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
IMPORTANT SAFETY INFORMATION
WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS
YERVOY can result in severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY.
Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests (LFTs), adrenocorticotropic hormone (ACTH) level, and thyroid function tests at baseline and before each dose.
Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions.
Immune-Mediated Pneumonitis
OPDIVO can cause immune-mediated pneumonitis. Fatal cases have been reported. Monitor patients for signs with radiographic imaging and for symptoms of pneumonitis. Administer corticosteroids for Grade 2 or more severe pneumonitis. Permanently discontinue for Grade 3 or 4 and withhold until resolution for Grade 2. In patients receiving OPDIVO monotherapy, fatal cases of immune-mediated pneumonitis have occurred. Immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated pneumonitis occurred in 6% (25/407) of patients.
In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 4.9% (13/263) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 3.4% (9/263) of patients receiving OPDIVO: Grade 3 (n=1) and Grade 2 (n=8).
Immune-Mediated Colitis
OPDIVO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO monotherapy for Grade 2 or 3 and permanently discontinue for Grade 4 or recurrent colitis upon re-initiation of OPDIVO. When administered with YERVOY, withhold OPDIVO and YERVOY for Grade 2 and permanently discontinue for Grade 3 or 4 or recurrent colitis. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated colitis occurred in 26% (107/407) of patients including three fatal cases.
In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal (diarrhea of ≥7 stools above baseline, fever, ileus, peritoneal signs; Grade 3-5) immune-mediated enterocolitis occurred in 34 (7%) patients. Across all YERVOY-treated patients in that study (n=511), 5 (1%) developed intestinal perforation, 4 (0.8%) died as a result of complications, and 26 (5%) were hospitalized for severe enterocolitis.
Immune-Mediated Hepatitis
OPDIVO can cause immune-mediated hepatitis. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater transaminase elevations. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated hepatitis occurred in 13% (51/407) of patients.
In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal hepatotoxicity (AST or ALT elevations >5x the ULN or total bilirubin elevations >3x the ULN; Grade 3-5) occurred in 8 (2%) patients, with fatal hepatic failure in 0.2% and hospitalization in 0.4%.
Immune-Mediated Neuropathies
In a separate Phase 3 study of YERVOY 3 mg/kg, 1 case of fatal Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral motor neuropathy were reported.
Immune-Mediated Endocrinopathies
OPDIVO can cause immune-mediated hypophysitis, immune-mediated adrenal insufficiency, autoimmune thyroid disorders, and Type 1 diabetes mellitus. Monitor patients for signs and symptoms of hypophysitis, signs and symptoms of adrenal insufficiency, thyroid function prior to and periodically during treatment, and hyperglycemia. Administer hormone replacement as clinically indicated and corticosteroids for Grade 2 or greater hypophysitis. Withhold for Grade 2 or 3 and permanently discontinue for Grade 4 hypophysitis. Administer corticosteroids for Grade 3 or 4 adrenal insufficiency. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 adrenal insufficiency. Administer hormone-replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism. Withhold OPDIVO for Grade 3 and permanently discontinue for Grade 4 hyperglycemia.
In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients. In patients receiving OPDIVO with YERVOY, hypophysitis occurred in 9% (36/407) of patients. In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994) of patients. In patients receiving OPDIVO with YERVOY, adrenal insufficiency occurred in 5% (21/407) of patients. In patients receiving OPDIVO monotherapy, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 9% (171/1994) of patients. Hyperthyroidism occurred in 2.7% (54/1994) of patients receiving OPDIVO monotherapy. In patients receiving OPDIVO with YERVOY, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (89/407) of patients. Hyperthyroidism occurred in 8% (34/407) of patients receiving OPDIVO with YERVOY. In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients. In patients receiving OPDIVO with YERVOY, diabetes occurred in 1.5% (6/407) of patients.
In a separate Phase 3 study of YERVOY 3 mg/kg, severe to life-threatening immune-mediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3-4) occurred in 9 (1.8%) patients. All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. 6 of the 9 patients were hospitalized for severe endocrinopathies.
Immune-Mediated Nephritis and Renal Dysfunction
OPDIVO can cause immune-mediated nephritis. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grades 2-4 increased serum creatinine. Withhold OPDIVO for Grade 2 or 3 and permanently discontinue for Grade 4 increased serum creatinine. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated nephritis and renal dysfunction occurred in 2.2% (9/407) of patients.
Immune-Mediated Skin Adverse Reactions and Dermatitis
OPDIVO can cause immune-mediated rash, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some cases with fatal outcome. Administer corticosteroids for Grade 3 or 4 rash. Withhold for Grade 3 and permanently discontinue for Grade 4 rash. For symptoms or signs of SJS or TEN, withhold OPDIVO and refer the patient for specialized care for assessment and treatment; if confirmed, permanently discontinue. In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated rash occurred in 22.6% (92/407) of patients.
In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal immune-mediated dermatitis (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3-5) occurred in 13 (2.5%) patients. 1 (0.2%) patient died as a result of toxic epidermal necrolysis. 1 additional patient required hospitalization for severe dermatitis.
Immune-Mediated Encephalitis
OPDIVO can cause immune-mediated encephalitis. Evaluation of patients with neurologic symptoms may include, but not be limited to, consultation with a neurologist, brain MRI, and lumbar puncture. Withhold OPDIVO in patients with new-onset moderate to severe neurologic signs or symptoms and evaluate to rule out other causes. If other etiologies are ruled out, administer corticosteroids and permanently discontinue OPDIVO for immune-mediated encephalitis. In patients receiving OPDIVO monotherapy, encephalitis occurred in 0.2% (3/1994) of patients. Fatal limbic encephalitis occurred in one patient after 7.2 months of exposure despite discontinuation of OPDIVO and administration of corticosteroids. Encephalitis occurred in one patient receiving OPDIVO with YERVOY (0.2%) after 1.7 months of exposure.
Other Immune-Mediated Adverse Reactions
Based on the severity of adverse reaction, permanently discontinue or withhold treatment, administer high-dose corticosteroids, and, if appropriate, initiate hormone-replacement therapy. Across clinical trials of OPDIVO the following clinically significant immune-mediated adverse reactions occurred in <1.0% of patients receiving OPDIVO: uveitis, iritis, pancreatitis, facial and abducens nerve paresis, demyelination, polymyalgia rheumatica, autoimmune neuropathy, Guillain-Barré syndrome, hypopituitarism, systemic inflammatory response syndrome, gastritis, duodenitis, sarcoidosis, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), myositis, myocarditis, rhabdomyolysis, motor dysfunction, vasculitis, and myasthenic syndrome.
Infusion Reactions
OPDIVO can cause severe infusion reactions, which have been reported in <1.0% of patients in clinical trials. Discontinue OPDIVO in patients with Grade 3 or 4 infusion reactions. Interrupt or slow the rate of infusion in patients with Grade 1 or 2. In patients receiving OPDIVO monotherapy, infusion-related reactions occurred in 6.4% (127/1994) of patients. In patients receiving OPDIVO with YERVOY, infusion-related reactions occurred in 2.5% (10/407) of patients.
Complications of Allogeneic HSCT after OPDIVO
Complications, including fatal events, occurred in patients who received allogeneic HSCT after OPDIVO. Outcomes were evaluated in 17 patients from Checkmate 205 and 039, who underwent allogeneic HSCT after discontinuing OPDIVO (15 with reduced-intensity conditioning, 2 with myeloablative conditioning). Thirty-five percent (6/17) of patients died from complications of allogeneic HSCT after OPDIVO. Five deaths occurred in the setting of severe or refractory GVHD. Grade 3 or higher acute GVHD was reported in 29% (5/17) of patients. Hyperacute GVHD was reported in 20% (n=2) of patients. A steroid-requiring febrile syndrome, without an identified infectious cause, was reported in 35% (n=6) of patients. Two cases of encephalitis were reported: Grade 3 (n=1) lymphocytic encephalitis without an identified infectious cause, and Grade 3 (n=1) suspected viral encephalitis. Hepatic veno-occlusive disease (VOD) occurred in one patient, who received reduced-intensity conditioned allogeneic HSCT and died of GVHD and multi-organ failure. Other cases of hepatic VOD after reduced-intensity conditioned allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptor blocking antibody before transplantation. Cases of fatal hyperacute GVHD have also been reported. These complications may occur despite intervening therapy between PD-1 blockade and allogeneic HSCT.
Follow patients closely for early evidence of transplant-related complications such as hyperacute GVHD, severe (Grade 3 to 4) acute GVHD, steroid-requiring febrile syndrome, hepatic VOD, and other immune-mediated adverse reactions, and intervene promptly.
Embryo-Fetal Toxicity
Based on their mechanisms of action, OPDIVO and YERVOY can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with an OPDIVO- or YERVOY- containing regimen and for at least 5 months after the last dose of OPDIVO.
Lactation
It is not known whether OPDIVO or YERVOY is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from an OPDIVO-containing regimen, advise women to discontinue breastfeeding during treatment. Advise women to discontinue nursing during treatment with YERVOY and for 3 months following the final dose.
Serious Adverse Reactions
In Checkmate 037, serious adverse reactions occurred in 41% of patients receiving OPDIVO (n=268). Grade 3 and 4 adverse reactions occurred in 42% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse drug reactions reported in 2% to <5% of patients receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase. In Checkmate 066, serious adverse reactions occurred in 36% of patients receiving OPDIVO (n=206). Grade 3 and 4 adverse reactions occurred in 41% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of patients receiving OPDIVO were gamma-glutamyltransferase increase (3.9%) and diarrhea (3.4%). In Checkmate 067, serious adverse reactions (73% and 37%), adverse reactions leading to permanent discontinuation (43% and 14%) or to dosing delays (55% and 28%), and Grade 3 or 4 adverse reactions (72% and 44%) all occurred more frequently in the OPDIVO plus YERVOY arm (n=313) relative to the OPDIVO arm (n=313). The most frequent (≥10%) serious adverse reactions in the OPDIVO plus YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.6%), colitis (10% and 1.6%), and pyrexia (10% and 0.6%). In Checkmate 017 and 057, serious adverse reactions occurred in 46% of patients receiving OPDIVO (n=418). The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. In Checkmate 025, serious adverse reactions occurred in 47% of patients receiving OPDIVO (n=406). The most frequent serious adverse reactions reported in ≥2% of patients were acute kidney injury, pleural effusion, pneumonia, diarrhea, and hypercalcemia. In Checkmate 205 and 039, among all patients (safety population [n=263]), adverse reactions leading to discontinuation (4.2%) or to dosing delays (23%) occurred. The most frequent serious adverse reactions reported in ≥1% of patients were infusion-related reaction, pneumonia, pleural effusion, pyrexia, rash and pneumonitis. Ten patients died from causes other than disease progression, including 6 who died from complications of allogeneic HSCT. Serious adverse reactions occurred in 21% of patients in the safety population (n=263) and 27% of patients in the subset of patients evaluated for efficacy (efficacy population [n=95]). In Checkmate 141, serious adverse reactions occurred in 49% of patients receiving OPDIVO. The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were pneumonia, dyspnea, respiratory failure, respiratory tract infections, and sepsis. In Checkmate 275, serious adverse reactions occurred in 54% of patients receiving OPDIVO (n=270). The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were urinary tract infection, sepsis, diarrhea, small intestine obstruction, and general physical health deterioration.
Common Adverse Reactions
In Checkmate 037, the most common adverse reaction (≥20%) reported with OPDIVO (n=268) was rash (21%). In Checkmate 066, the most common adverse reactions (≥20%) reported with OPDIVO (n=206) vs dacarbazine (n=205) were fatigue (49% vs 39%), musculoskeletal pain (32% vs 25%), rash (28% vs 12%), and pruritus (23% vs 12%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO plus YERVOY arm (n=313) were fatigue (59%), rash (53%), diarrhea (52%), nausea (40%), pyrexia (37%), vomiting (28%), and dyspnea (20%). The most common (≥20%) adverse reactions in the OPDIVO (n=313) arm were fatigue (53%), rash (40%), diarrhea (31%), and nausea (28%). In Checkmate 017 and 057, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=418) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite. In Checkmate 025, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=406) vs everolimus (n=397) were asthenic conditions (56% vs 57%), cough (34% vs 38%), nausea (28% vs 29%), rash (28% vs 36%), dyspnea (27% vs 31%), diarrhea (25% vs 32%), constipation (23% vs 18%), decreased appetite (23% vs 30%), back pain (21% vs 16%), and arthralgia (20% vs 14%). In Checkmate 205 and 039, among all patients (safety population [n=263]) and the subset of patients in the efficacy population (n=95), respectively, the most common adverse reactions (≥20%) were fatigue (32% and 43%), upper respiratory tract infection (28% and 48%), pyrexia (24% and 35%), diarrhea (23% and 30%), and cough (22% and 35%). In the subset of patients in the efficacy population (n=95), the most common adverse reactions also included rash (31%), musculoskeletal pain (27%), pruritus (25%), nausea (23%), arthralgia (21%), and peripheral neuropathy (21%). In Checkmate 141, the most common adverse reactions (≥10%) in patients receiving OPDIVO were cough and dyspnea at a higher incidence than investigator’s choice. In Checkmate 275, the most common adverse reactions (≥ 20%) reported in patients receiving OPDIVO (n=270) were fatigue (46%), musculoskeletal pain (30%), nausea (22%), and decreased appetite (22%).
In a separate Phase 3 study of YERVOY 3 mg/kg, the most common adverse reactions (≥5%) in patients who received YERVOY at 3 mg/kg were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and colitis (8%).
Checkmate Trials and Patient Populations
Checkmate 067 - advanced melanoma alone or in combination with YERVOY; Checkmate 037 and 066 - advanced melanoma; Checkmate 017 - squamous non-small cell lung cancer (NSCLC); Checkmate 057 - non-squamous NSCLC; Checkmate 025 - renal cell carcinoma; Checkmate 205/039 - classical Hodgkin lymphoma; Checkmate 141 – squamous cell carcinoma of the head and neck; Checkmate 275 - urothelial carcinoma.
Please see U.S. Full Prescribing Information for OPDIVO and YERVOY, including Boxed WARNING regarding immune-mediated adverse reactions for YERVOY.
About the Bristol-Myers Squibb and Ono Pharmaceutical Co., Ltd. Collaboration
In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Ltd (Ono), Bristol-Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Bristol-Myers Squibb and Ono further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2016 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170428005855/en/
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BMY
Tom Lynch outlines his comeback strategy for Bristol-Myers’ badly bruised R&D organization
by john carroll
April 28, 2017 08:44 AM EDT
Updated: 08:56 AM
Thomas Lynch
When Tom Lynch took the top R&D job at Bristol-Myers Squibb, he got one of the best — and at the same time, one of the hardest — jobs in biotech.
It was one of the best because Bristol-Myers built what is widely considered one of the most innovative research groups for a biopharma of its size, in a heavyweight class not known for homemade breakthroughs. It was one of the hardest because the group had just derailed, giving up its first-place position in immuno-oncology in a hard fall on a misguided late-stage effort on lung cancer.
That’s how Lynch ended up with the job.
During yesterday’s Q1 call with analysts, Lynch — who made an unusual move from the board to head of R&D — outlined his strategy for what comes next. How can Bristol-Myers retrieve its lead position?
As Lynch noted to a group that included some experienced skeptics, his boardroom position gave him a bird’s eye view of the company’s operations. For a first interview with analysts, he provided an impressive, detailed strategy outline, recognizing the weaknesses in Bristol-Myers’ I/O efforts and offering ways to deal with those weaknesses in the clinic.
Lynch’s game plan centers on the company’s work on next-gen combos, looking to build on Opdivo (PD-1) and Yervoy (CTLA-4) — with all its faults — with new combos and less toxic alternatives now in the clinic.
In Lynch’s words, here’s the strategy:
— (F)irst, accelerating the delivery of our next wave of I-O assets like IDO, which we recently presented data on at AACR. We’ll also be presenting early results for LAG-3, GITR, and the Incyte IDO at ASCO this year.
— Second, understanding the biology of I-O resistance, both intrinsic resistance and acquired, and bringing a laser-like focus to overcoming this. We will focus on expanding into tumor types where I-O hasn’t had a broad impact yet, tumors like breast cancer, colorectal cancer, and prostate cancer. We will use our next-wave assets to create options for patients who progress on their initial I-O therapy.
— Third, we will continue to develop combination regimens, including I-O/I-O combinations, I-O/targeted combinations, and I-O/chemotherapy combinations where these make sense.
— And fourth, we will accelerate the development of our most promising assets in the cardiovascular, immuno-science, and fibrosis pipeline. As [CEO] Giovanni [Caforio] mentioned, we recently presented promising Phase II data on our FGF21 asset in patients with NASH at the International Liver Congress. The results showed an improvement across multiple aspects of NASH, including a significant reduction in liver fat versus placebo.
He followed up by citing an expanded relationship with CytomX to build a less toxic CTLA-4, a move that could eventually have major implications for contenders like AstraZeneca, and all the big rivals currently in the market, from Merck to Roche and Pfizer/Merck KGaA. IDO combinations will play a role here as well.
Geoff Meacham at Barclays observes that it seems that the biggest opportunity is in “cold tumors, breast, ovarian, colon, et cetera. To follow up on the earlier comment, CTLA-4 combos, do you guys feel, at this point, CTLA-4 combos plus a PD-L1 is going to be a component of that?”
Lynch:
So we think we have multiple opportunities to look at combinations of I-O/I-O agents in these cold tumors. We presented data with our IDO asset, as you mentioned, and we also will be presenting initial data at ASCO this year with our GITR compound, which could be the type of agent that might play a role in the cold tumor space.
Tim Anderson at Bernstein also zeroed in on growing questions about the future of PD-1, CTLA-4 combos. “A bear’s point of view could say that this foretells problems with Yervoy and Opdivo, specifically in front-line lung.”
Lynch:
I think the first is that again, just emphasizing how complex and difficult a disease lung cancer is to treat, it’s highly unlikely that there’s going to be one approach that’s going to fit every patient who presents in first-line. We believe strongly that Yervoy/Opdivo is certainly one of the options that needs to be pursued and developed, and we’re looking at that in first-line lung cancer. And we’re also looking at it in the setting of what appropriate biomarkers might be important in evaluating the potential for this combination and for really all of our drugs in first-line lung cancer.
Finally, on new R&D investments:
“(W)e’ve got to execute our pipeline. We’ve got to develop our next-generation drugs. And to do that, we’re going to need to invest in tumor biology and translational medicine as well as data and analytics.”
So there’s the plan. Taking over at R&D now is like jumping on a rolling truck at Bristol-Myers, which spent $5 billion on research last year. You can grab the wheel, but then you have to manage the momentum. That won’t be easy.
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https://endpts.com/tom-lynch-outlines-his-comeback-strategy-for-bristol-myers-badly-bruised-rd-organization/
BMY
Had noticed and was surprised that the revised lower was above or almost at the prior upper figures. So bullish, together with the actual results, that the gains yesterday should have been much higher don't you think? A lot of analysts at the CC so hopefully will get some upgrades.
BMY
Good news keeps coming. Surprised to see it among the MarketWatch headlines:
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China FDA Approves Country’s First All-Oral Regimen for Chronic Hepatitis C, Daklinza® (daclatasvir) in Combination with S...
Date : 04/28/2017 @ 7:19AM
Source : Business Wire
Daklinza and Sunvepra combination approved for genotype 1b, the most common chronic hepatitis C (HCV) genotype in China; combination has a 91-99% cure rate
Daklinza also approved in China for use in combination with other agents, including sofosbuvir, for HCV genotypes 1-6
Bristol-Myers Squibb Company (NYSE:BMY) announced today that the China Food and Drug Administration (CFDA) has approved a direct-acting antiviral regimen comprised of Daklinza® (daclatasvir) and Sunvepra® (asunaprevir), for the treatment of treatment-naive or -experienced patients, with or without compensated cirrhosis, infected with genotype 1b chronic hepatitis C virus (HCV). This is China’s first all-oral, interferon- and ribavirin-free HCV treatment regimen. In addition, Daklinza has been approved in China for combination use with other agents, including sofosbuvir, for adult patients with HCV genotypes 1-6 infection. This is the only all-oral pan-genotypic regimen recommended by China’s HCV Prevention and Treatment Guideline. Daklinza must not be administered as monotherapy. Sofosbuvir is under review by the CFDA, and is not currently licensed in China.
In more than 60 countries, Daklinza is approved as part of a regimen with either Sunvepra or sofosbuvir. In China, Daklinza-based regimens provide a shorter treatment duration (12 or 24 weeks) compared to 48 weeks of treatment with previously approved regimens. The Daklinza and Sunvepra regimen is already approved by regulatory authorities in multiple countries across the Asia Pacific, Latin America, and Eastern Europe regions. Sunvepra is not approved in the United States.
“The burden of HCV in China is extremely high, and now for the first time, we have an all-oral treatment option in the combination of Daklinza and Sunvepra, which is a significant step forward for patients and doctors alike,” said Hui Zhuang, a professor at the Beijing University Medical School and a member of the Chinese Academy of Engineering. “This new option helps to address many of the unmet needs for our HCV genotype 1b patients, and is also included in the latest edition of China’s HCV Prevention and Treatment Guideline.”
The approval is based primarily upon results of the first completed Phase 3 036 trial of the Daklinza and Sunvepra regimen for HCV among Chinese patients, which was published in the November 2016 issue of the Journal of Gastroenterology and Hepatology. In the trial, 91% (145/159) of genotype 1b patients who had been previously interferon-ineligible or interferon-intolerant achieved sustained virologic response (“SVR”, or cure) at post-treatment week 24. The cure rate was higher, at 99%, in patients without baseline NS5A resistance-associated variants (RAVs; L31M or Y93H; n=137/139).
As detailed in the published Phase 3 trial, one death (0.6%), five on-treatment serious adverse events (3%), and three grade 4 laboratory abnormalities (2%) occurred on-treatment; none were considered related to study drugs. Two patients (1%) discontinued due to adverse events (AEs). The most common grade 1–4 on-treatment AEs (>5% of patients) were platelet count decrease (14, 9%), upper respiratory tract infection (13, 8%), ALT increase (a diagnostic indication of liver disease or damage) (11, 7%), neutrophil count decrease (11, 7%), monocyte (large white blood cell) count decrease (10, 6%), white blood cell count decrease (10, 6%), thrombocytopenia (decrease in the number of platelets in the blood) (10, 6%), and pruritus (itchiness) (9, 6%); most were mild or moderate in intensity. Treatment was generally well-tolerated regardless of cirrhosis status.
“We are proud to build on our legacy, infrastructure and experience in treating viral hepatitis throughout Asia by bringing Daklinza-based regimens to patients in China,” said Murdo Gordon, executive vice president and chief commercial officer, Bristol-Myers Squibb. “Beginning with our efforts to treat chronic hepatitis B, Bristol-Myers Squibb has been committed to combating viral hepatitis in China for over a decade.”
HCV represents a significant public health burden in China and is now the fourth most commonly reported infectious disease countrywide, with an estimated 10 million people currently living with the disease. Until now, standard of care in China has been interferon- and ribavirin-containing regimens which have left some patient groups with unmet needs. The cure rate for interferon- and ribavirin- containing regimens varies in a number of recent Chinese studies. In CCgenos, a real-world observation study, the cure rate for interferon- and ribavirin- containing regimens among GT-1b naïve patients is 62.4%.
Karl Lintel, MD, President of Bristol-Myers Squibb (China) Investment Co. Ltd and the Sino-American Shanghai Squibb Pharmaceutical Co., commented, “Today’s approval of Daklinza and Sunvepra is great news for patients in China, as we continue the global fight against chronic hepatitis C. This milestone is testament to our ongoing collaboration with multiple stakeholders, and aligning with government policies to provide continuing support to HCV patients at the community level.”
Bristol-Myers Squibb is committed to working with stakeholders to seek timely reimbursement for Daklinza and Sunvepra at the national and provincial levels, to ensure patients have access to these important products.
About the 036 Clinical Trial
In the multi-center Asian study, interferon-ineligible and -intolerant patients with genotype 1b infection received Daklinza 60 mg tablets once-daily plus Sunvepra 100 mg soft capsules twice-daily for 24 weeks. Of the 159 patients enrolled, 127 were from mainland China. The primary endpoint was SVR at post-treatment Week 24 (SVR24).
In the overall study population, the SVR24 was 91% (145/159) and was similarly high in cirrhotic patients (47/52, 90%). SVR24 rates were higher (137/139) [99%]) in patients without baseline NS5A RAVs (L31M or Y93H), and lower in patients with baseline NS5A RAVs (8/19 [42%]).
Prevalence of baseline NS5A RAVs was 12% (19/159) overall, and 8% in mainland China patients (10/127). HCV NS5A RAVs exist naturally (albeit in lower prevalence vs wildtype) and can emerge after virologic response failure. Screening for the presence of specific NS5A mutations can help physicians determine the most suitable patients for treatment by identifying those most likely to achieve cure with an NS5A-containing regimen.
Data from other studies conducted outside of China investigating Daklinza in combination with sofosbuvir were also considered as part of the approval.
About the 114 Clinical Trial
In a multi-center study, treatment-naive patients with genotype 1b infection received Daklinza 60 mg tablets once-daily plus Sunvepra 100 mg soft capsule twice-daily for 24 weeks. Of the total 206 patients, 161 were from mainland China. Patients were randomized 3:1 into two treatment arms: an immediate Daklinza and Sunvepra treatment group (n=155) or a placebo-deferred Daklinza and Sunvepra treatment group (n=52). The primary endpoint was SVR at post-treatment Week 12 (SVR12) in the immediate treatment arm, for comparison with the historical SVR rate achieved with pegIFN/RBV (70%).
The SVR12 rate was 92% in treatment-naive patients with HCV genotype 1b infection in the immediate treatment arm. Baseline NS5A-L31 or Y93H polymorphisms were present in 11% (17/154) of these patients. The SVR12 rate was 96% (132/137) in patients without these baseline polymorphisms; 89% (17/19) with cirrhosis, 97% (115/118) without cirrhosis.
Discontinuations due to AEs were infrequent (1%). The most common AEs (any grade, ≥5%) in the overall population were ALT increase, upper respiratory tract infection, hypertension, AST elevation, INR elevation, blood bilirubin elevation, and fatigue.
Bristol-Myers Squibb’s Leadership in Viral Hepatitis
Bristol-Myers Squibb’s heritage in virology in China began with Baraclude® (entecavir), a market-leading oral treatment for patients suffering with chronic hepatitis B virus (CHBV). Baraclude is indicated in China for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum alanine aminotransferase (ALT) or histologically active disease. Since its approval in China in 2005, Bristol-Myers Squibb has worked to not only provide access to Baraclude, but also to coordinate with government, local hospitals and physicians, and NGOs to raise the standard of care and improve the quality of life and survival of patients with HBV. In China, more than 1 million patients have been treated with Baraclude, and Asia has accounted for more than two-thirds of all Baraclude prescriptions.
Since 2002, the Bristol-Myers Squibb Foundation also has been leading efforts at the community level in Asia in HBV and HCV awareness, destigmatization, prevention, and care through the Delivering Hope program. The multi-pronged program includes a variety of disease education and vaccination efforts, including prevention of the most common means of transmission, from mother to child. It also includes capacity building, and training in partnership with local NGOs, governments and healthcare workers. In China alone, more than 8 million people at high risk of hepatitis infection across 28 provinces have benefitted from these programs over the past decade. The Foundation has committed more than $9.6 million (U.S.) in grants to a diverse group of organizations for programs targeting specific populations.
About Daclatasvir
Daclatasvir, marketed as Daklinza, is a NS5A replication complex inhibitor which targets the NS5A protein by directly disrupting its normal function. The NS5A protein plays essential roles in the HCV viral life cycle, including viral RNA replication and virion (viral particle) assembly. Daklinza is approved by the U.S. Food and Drug Administration (FDA) for use with sofosbuvir, with or without ribavirin, for the treatment of patients with HCV genotype 1 or genotype 3 infection. Sustained virologic response (SVR12) rates are reduced in HCV genotype 3-infected patients with cirrhosis receiving Daklinza in combination with sofosbuvir for 12 weeks. Daklinza is approved by the European Medicines Agency (EMA) for patients with HCV genotypes 1, 3, or 4.
Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with Daklinza. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate management for HBV infection as clinically indicated. Please see full Important Safety Information below for more details.
About Asunaprevir
Asunaprevir, marketed as Sunvepra, is an NS3 protease inhibitor, an agent that binds to the NS3 protein of the HCV virus to block its activity. The NS3/4A protease plays an essential role in the assembly of the viral replication complex. Sunvepra is approved in 17 countries around the world, including in the Asia Pacific, Latin America, and Eastern Europe regions; Sunvepra is not approved in the United States. Sunvepra is approved as part of a regimen with Daklinza for the treatment of HCV genotype 1b infection in adult patients. For patients receiving Sunvepra-containing regimens, frequent monitoring of liver enzymes (alanine aminotransferase (ALT), aspartate aminotransferase (AST)) and bilirubin is required until completion of therapy.
About Bristol-Myers Squibb in HCV
Bristol-Myers Squibb is focused on helping to eradicate hepatitis C around the world, with a primary emphasis on difficult-to-treat patients, including those millions in countries where population-based HCV solutions remain a high unmet need.
In July 2014, Japan became the first country in the world to approve the use of a daclatasvir-based regimen for the treatment of chronic hepatitis C. Since then, daclatasvir-based regimens have been approved in more than 60 countries across North, Central and South America, Europe, the Middle East and the Asia-Pacific region.
U.S. Indication and Important Safety Information - Daklinza™ (daclatasvir)
INDICATIONS
Daklinza™ (daclatasvir) is indicated for use with sofosbuvir, with or without ribavirin, for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1 or genotype 3 infection.
Limitations of Use:
Sustained virologic response (SVR12) rates are reduced in HCV genotype 3-infected patients with cirrhosis receiving Daklinza in combination with sofosbuvir for 12 weeks.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV
Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with Daklinza. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate management for HBV infection as clinically indicated.
CONTRAINDICATIONS
When used in combination with other agents, the contraindications applicable to those agents are applicable to the combination regimen; refer to the respective prescribing information.
Drugs contraindicated with Daklinza: strong inducers of CYP3A that may lead to loss of efficacy of Daklinza include, but are not limited to: phenytoin, carbamazepine, rifampin, St. John’s wort (Hypericum perforatum).
WARNINGS AND PRECAUTIONS
Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV (additional information): HBV reactivation has also been reported in patients receiving certain immunosuppressant or chemotherapeutic agents; the risk of HBV reactivation may be increased in these patients.
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions: Coadministration of Daklinza and other drugs may result in known or potentially significant drug interactions. Interactions may include the loss of therapeutic effect of Daklinza and possible development of resistance, dosage adjustments for other agents or Daklinza, possible clinically significant adverse events from greater exposure for the other agents or Daklinza.
Serious Symptomatic Bradycardia When Coadministered with Sofosbuvir and Amiodarone: Post-marketing cases of symptomatic bradycardia and cases requiring pacemaker intervention have been reported when amiodarone is coadministered with sofosbuvir in combination with another direct-acting antiviral, including Daklinza. A fatal cardiac arrest was reported with ledipasvir/sofosbuvir.
Coadministration of amiodarone with Daklinza in combination with sofosbuvir is not recommended. For patients taking amiodarone who have no alternative treatment options, patients should undergo cardiac monitoring, as outlined in Section 5.3 of the prescribing information.
Patients also taking beta blockers or those with underlying cardiac comorbidities and/or advanced liver disease may be at increased risk for symptomatic bradycardia with coadministration of amiodarone.
Bradycardia generally resolved after discontinuation of HCV treatment.
Risks Associated with Ribavirin Combination Treatment: If ribavirin is used as part of the regimen, the warnings and precautions for ribavirin, particularly the pregnancy avoidance warning, apply. See the ribavirin full prescribing information for complete information.
ADVERSE REACTIONS
In clinical trials (ALLY 2, 3) with the Daklinza and sofosbuvir regimen, the most common adverse reactions (≥5%) were, respectively: headache (8%, 14%), fatigue (15%, 14%), nausea (9%, 8%), diarrhea (7%, 5%).
In clinical trials (ALLY 1) with Daklinza, in combination with sofosbuvir and ribavirin, the most common adverse reactions (≥5%) were, in the cirrhosis cohort and the post-liver transplantation cohort, respectively: headache (12%, 30%), anemia (20%, 19%), fatigue (15%, 17%), nausea (15%, 6%), rash (8%, 2%), diarrhea (3%, 6%), insomnia (3%, 6%), dizziness (0, 6%), somnolence (5%, 0).
DRUG INTERACTIONS
CYP3A: Daklinza is a substrate. Moderate or strong inducers may decrease plasma levels and effect of Daklinza. Strong inhibitors (e.g., clarithromycin, itraconazole, ketoconazole, ritonavir) may increase plasma levels of Daklinza.
P-gp, OATP 1B1 and 1B3, and BCRP: Daklinza is an inhibitor, and may increase exposure to substrates, potentially increasing or prolonging their adverse effect.
See Sections 4, 7, and 12.3 of the Daklinza Full Prescribing Information for additional established and other potentially significant drug interactions and related dose modification recommendations. Refer to the prescribing information for other agents in the regimen for drug interaction information.
DAKLINZA IN PREGNANCY
No adequate human data are available to determine whether or not Daklinza poses a risk to pregnancy outcomes. Animal studies of Daklinza at exposure above the recommended human dose have shown maternal and embryofetal toxicity.
If Daklinza and sofosbuvir are administered with ribavirin, the information for ribavirin with regard to pregnancy testing, contraception, and infertility also applies to this combination regimen. Refer to the ribavirin prescribing information.
LACTATION
It is not known whether Daklinza is present in human milk, affects human milk production, or has effects on the breastfed infant. Daklinza was present in the milk of lactating rats. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for Daklinza and any potential adverse effects on the breastfed child from Daklinza or from the underlying condition.
When Daklinza is administered with ribavirin, the nursing mothers’ information for ribavirin also applies to this combination regimen. Refer to the nursing mothers’ information in the ribavirin prescribing information.
Please see Full Prescribing Information, including Boxed WARNING here.
U.S. Indication and Important Safety Information - BARACLUDE® (entecavir):
INDICATION
BARACLUDE (entecavir) is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults and pediatric patients 2 years of age or older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
The following points should be considered when initiating therapy with BARACLUDE:
In adult patients, this indication is based on clinical trial data in nucleoside-inhibitor treatment-naïve and lamivudine-resistant subjects with HBeAg-positive and HBeAgnegative HBV infection and compensated liver disease and a more limited number of subjects with decompensated liver disease.
In pediatric patients 2 years of age and older, this indication is based on clinical trial data in nucleoside-inhibitor-treatment-naïve and in a limited number of lamivudine experienced subjects with HBeAg-positive chronic HBV infection and compensated liver disease.
IMPORTANT SAFETY INFORMATION
WARNINGS: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-INFECTED WITH HIV AND HBV, and LACTIC ACIDOSIS AND HEPATOMEGALY
Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
Limited clinical experience suggests there is a potential for the development of resistance to HIV (human immunodeficiency virus) nucleoside reverse transcriptase inhibitors if BARACLUDE is used to treat chronic HBV infection in patients with HIV infection that is not being treated. Therapy with BARACLUDE is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART).
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, alone or in combination with antiretrovirals.
Warnings and Precautions
Before initiating BARACLUDE therapy, HIV antibody testing should be offered to all patients. BARACLUDE has not been studied as a treatment for HIV infection and is not recommended for this use.
Lactic acidosis with BARACLUDE use has been reported, often in association with hepatic decompensation, other serious medical conditions, or drug exposures. Patients with decompensated liver disease may be at higher risk for lactic acidosis. BARACLUDE should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.
Adverse Reactions
In clinical trials in patients with compensated liver disease, the most common (≥3%) adverse reactions of any severity with at least a possible relation to study drug for BARACLUDE-treated subjects were headache, fatigue, dizziness, and nausea. In these trials, the most common adverse reactions of moderate to severe intensity (grades 2-4) were diarrhea, dyspepsia, nausea, vomiting, fatigue, headache, dizziness, somnolence, and insomnia.
In the decompensated liver disease trial, the most common adverse reactions of any severity among patients treated with BARACLUDE, regardless of causality, included: peripheral edema (16%), ascites (15%), pyrexia (14%), hepatic encephalopathy (10%), and upper respiratory infection (10%). In this trial, 18% (18/102) of BARACLUDE patients and 20% (18/89) of adefovir patients died during the first 48 weeks of therapy. The majority of those deaths were due to liver related causes.
Drug Interactions
BARACLUDE (entecavir) is primarily eliminated by the kidneys; therefore coadministration of BARACLUDE with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. Patients should be monitored closely when receiving BARACLUDE with other renally-eliminated drugs.
Pregnancy and Nursing Mothers
There are no adequate and well-controlled studies of BARACLUDE in pregnant women. BARACLUDE should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
There are no studies on the effect of BARACLUDE on transmission of HBV from mother to infant. Therefore, appropriate interventions should be used to prevent neonatal acquisition of HBV.
It is not known whether BARACLUDE is excreted into human milk; however, many drugs are excreted into breast milk. Due to the potential for serious adverse reactions in nursing infants from BARACLUDE, risks and benefits should be considered when deciding whether to discontinue breast-feeding or discontinue BARACLUDE in nursing women.
Pediatric Use
The adverse reactions observed in pediatric patients who received treatment with BARACLUDE were consistent with those observed in clinical trials of BARACLUDE in adults. Adverse drug reactions reported in greater than 1% of pediatric patients included abdominal pain, rash events, poor palatability (“product taste abnormal”), nausea, diarrhea, and vomiting.
Due to limited data, in lamivudine-experienced pediatric patients, Baraclude should be used only if the potential benefit justifies the potential risk to the child. Consideration should be given to the impact of BARACLUDE on future treatment options.
Renal Impairment
Dosage adjustment of BARACLUDE is recommended for patients with a creatinine clearance <50 mL/min, including those on hemodialysis or continuous ambulatory peritoneal dialysis. There is insufficient data to recommend specific dosage adjustments of BARACLUDE in pediatric patients with renal impairment, however dosage adjustments similar to those for adults should be considered.
Liver Transplant Recipients
Renal function must be carefully monitored both before and during treatment with BARACLUDE in a liver transplant recipient who has received or is receiving an immunosuppressant that may affect renal function, such as cyclosporine or tacrolimus.
Duration of Therapy
The optimal duration of treatment with BARACLUDE for patients with chronic HBV infection and the relationship between treatment and long-term outcomes such as cirrhosis and hepatocellularcarcinoma are unknown.
Additional Information
BARACLUDE is not a cure for HBV. Patients should be advised that treatment with BARACLUDE has not been shown to reduce the risk of transmission of HBV to others through sexual contact or blood contamination.
Please click here for the BARACLUDE full prescribing information, including Boxed WARNINGS.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.
Bristol-Myers Squibb Forward Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2016, in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170428005329/en/
Bristol-Myers Squibb
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Aeterna Zentaris to sell 2.24M common shares ATM; stock down 5% premarket
Apr. 28, 2017 7:39 AM ET|By: Douglas W. House, SA News Editor
Aeterna Zentaris (NASDAQ:AEZS) inks an At The Market Issuance Sales Agreement with H.C. Wainwright for the sale and distribution of up to 2.24M shares of common stock generating up to $6.944M in proceeds (average price: $3.10). The new deal supersedes the prior ATM agreement implemented in April 2016.
Yesterday's close was $3.05. Shares are off 5% premarket on light volume.
_________________________________________________
https://seekingalpha.com/news/3261204-aeterna-zentaris-sell-2_24m-common-shares-atm-stock-5-percent-premarket?app=1&uprof=46#email_link
(I have no shares)
AEZS
CC transcript from Seeking Alpha:
Bristol-Myers Squibb (BMY) Q1 2017 Results - Earnings Call Transcript
Apr. 27, 2017 3:25 PM ET| About: Bristol-Myers Squibb Company (BMY)
Q1: 04-23-17 Earnings Summary
Bristol-Myers Squibb Co. (NYSE:BMY)
Q1 2017 Earnings Call
April 27, 2017 10:30 am ET
Executives
John E. Elicker - Bristol-Myers Squibb Co.
Giovanni Caforio - Bristol-Myers Squibb Co.
Thomas James Lynch - Bristol-Myers Squibb Co.
Charles A. Bancroft - Bristol-Myers Squibb Co.
Murdo Gordon - Bristol-Myers Squibb Co.
Analysts
Christopher Schott - JPMorgan Securities LLC
Geoffrey Meacham - Barclays Capital, Inc.
Gregg Gilbert - Deutsche Bank Securities, Inc.
Charles Anthony Butler - Guggenheim Securities LLC
Seamus Fernandez - Leerink Partners LLC
Timothy Minton Anderson - Sanford C. Bernstein & Co. LLC
Jami Rubin - Goldman Sachs & Co.
Alex Arfaei - BMO Capital Markets (United States)
David R. Risinger - Morgan Stanley & Co. LLC
Andrew S. Baum - Citigroup Global Markets Ltd.
John T. Boris - SunTrust Robinson Humphrey, Inc.
Operator
Good day, everyone, and welcome to today's Bristol-Myers Squibb 2017 first quarter results conference call. Today's conference is being recorded.
And at this time, I like to turn the conference over to Mr. John Elicker, Senior Vice President, Public Affairs and Investor Relations. Please go ahead, sir.
John E. Elicker - Bristol-Myers Squibb Co.
Thanks, Melody, and good morning, everybody. Thanks for joining us to review our first quarter results. With me this morning are Giovanni Caforio, our Chief Executive Officer; Charlie Bancroft, our Chief Financial Officer; Tom Lynch, our new Chief Scientific Officer; and Murdo Gordon, our Chief Commercial Officer. Giovanni, Tom, and Charlie will have prepared remarks, and then Murdo will certainly be available for Q&A as well.
Before we get started and I turn it over to Giovanni, I'll take care of the Safe Harbor language. During the call, we'll make statements about the company's future plans and prospects that constitute forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the company's SEC filings. These forward-looking statements represent our estimates as of today and should not be relied upon as representing our estimates as of any future date. We specifically disclaim any obligation to update forward-looking statements even if our estimates change.
We will also focus our comments on our non-GAAP financial measures, which are adjusted to exclude certain specified items. Reconciliations of these non-GAAP financial measures to the most comparable GAAP measures are available at our website.
Giovanni?
Giovanni Caforio - Bristol-Myers Squibb Co.
Thanks, John. Good morning, everyone
I think it's fair to say we just had an outstanding quarter with strong performance across the company. Our non-GAAP EPS was $0.84, up $0.10 over the first quarter of last year. We grew our revenue by 12%, with double-digit growth across our key growth drivers.
Starting with I-O, sales for Opdivo were strong despite a more competitive landscape in the U.S. for lung cancer. In the U.S., while we have seen some share loss in lung cancer, our share has shown signs of stabilization in recent weeks. Outside lung, we've seen growth in renal, melanoma, head and neck, and bladder. Internationally, we've made great progress on access and reimbursement. Sales were strong across all indications.
From a regulatory perspective, we continue to make progress, mainly the U.S. Opdivo approval in bladder, the Japanese approval in head and neck, and the CHMP positive recommendations for bladder and head and neck in Europe.
We shared important new data from our immuno-oncology portfolio at AACR [American Association of Cancer Research], including overall survival data from Study 67, the TNB analysis from Study 26, and the early data from our IDO inhibitor.
We also advanced our diversified portfolio with encouraging data from our FGF21 for NASH at EASL [European Association for the Study of the Liver], and we will work with the regulatory authorities to initiate a registrational program as soon as possible.
We made significant progress from a business development perspective, investing in translational capabilities through deals like GRAIL and Foundation Medicine and broadening our immuno-oncology clinical development program through agreements to study combination approaches with different mechanisms across a range of tumor.
As I look at the company going forward, I see tremendous opportunity, driven by our industry-leading portfolio and the very best people in the business, all focused on maximizing value for our marketed products and advancing our pipeline.
Certainly, all of you are focused on our I-O portfolio and our lung cancer program in particular. This is a key focus for us as well. The first-line landscape has become very dynamic, and the outlook for this market is continually evolving. Our teams have done a great job maintaining our position, and we believe we have the most comprehensive program in first-line. I'm sure you'll have questions about our development program in lung, but let me just say here that over the next 12 to 18 months, we expect to see a lot of important data.
But we are not just a lung cancer company. Over the next 12 months, we are also anticipating important data readouts for Opdivo and Yervoy in renal cancer, hepatocellular carcinoma, and small-cell lung cancer.
We also have many important opportunities in a range of other tumor types. This is particularly true with respect to our next wave of I-O assets, with 10 new mechanisms in addition to PD-1 and CTLA-4 in clinical development. During the year, we plan to present additional data from first disclosures for many of our next wave I-O assets, beginning at ASCO [American Society of Clinical Oncology], where we will show IDO, GITR, and LAG-3. Tom will speak more about all of this in a moment, underscoring the critical importance of translational medicine to the work we are doing here as well as across our other therapeutic areas.
And we are not just a cancer company. This is clear by Eliquis' continued strong performance in the U.S. and other key markets and by the double-digit growth of Orencia and Sprycel. Eliquis has now exceeded $1 billion in revenue in the quarter and is the leading NOAC [Novel Oral Anti-Coagulant] in the U.S. based on total prescriptions. And importantly, we are continuing to see warfarin usage decline in terms of new-to-brand scripts, and we expect this trend to continue as the NOAC class expands.
It is also clear by the fact that we will have data to potentially support three registrational starts in the next 12 months in our fibrosis and immuno-science portfolios. Our fibrosis pipeline includes first-in-class and best-in-class opportunities, with a focus on fibrosis of the liver and lung. And we believe our first compound for NASH, PEG-FGF21, has significant potential in an area with great need for new treatments. In immuno-science, we are pursuing novel mechanisms to treat a number of different autoimmune diseases, including lupus, RA, inflammatory bowel disease, Sjögren, and others.
Beyond our strong performance and pipeline, we continue to look at a balanced approach to capital allocation as a key part of our strategy. Business development continues to be a priority for us, and we are sourcing external opportunities across the preclinical and clinical areas as well as building our translational capabilities. Charlie will talk later about our progress in that area during the quarter. All in all, I feel really good about the quarter and the opportunities that lie ahead.
As John mentioned, we are pleased that Tom has joined our company and is with us here today. Tom brings an important mix of experiences to his new position: his deep scientific expertise as a researcher, having led clinical trial design and drug development, primarily in lung cancer; his work as a practicing physician who has treated thousands of patients; his years of collaboration with academia and the larger scientific community; his leadership experience in large organizations, most recently at MGH [Massachusetts General Hospital], where he gained a deep understanding of the payer environment and the importance of value in ensuring access to medicines for serious diseases; and of course, his work as a member of our board for the past few years. Taken together, Tom has the experience and energy needed to realize the full potential of our pipeline.
Here, let me again express my personal gratitude to Francis Cuss for his more than 13 years with our company. Francis made significant contributions to our R&D organization during a transformative year for Bristol-Myers Squibb, and I couldn't be more grateful.
And with that, I will turn it over to Tom. Thank you.
Thomas James Lynch - Bristol-Myers Squibb Co.
Thank you, Giovanni. Good morning, everyone. I'm truly delighted to be joining my first earnings call as Chief Scientific Officer of Bristol-Myers Squibb. As Giovanni mentioned, there is great potential in our pipeline. I knew this from my role on the Board of Directors, and it was the major reason I decided to join the management team.
Our breath and particularly our depth in I-O position Bristol-Myers Squibb to make a major difference in how common cancers are treated and even allow us to begin to think about the possibility of cure for many types of cancer. In the short time that I've been in this role, just over six weeks, I've become even more enthusiastic about the opportunity with our pipeline and our people, both within oncology and across our cardiovascular, immuno-science, and fibrosis assets.
As I meet with my discovery and development teams here in Princeton, in Redwood City, and across the globe, I'm struck that BMS is a company with remarkable R&D talent, particularly in antibody technology, medicinal chemistry, clinical development, and in our regulatory operations. This coupled with the strong integration between R&D and commercial makes me very optimistic about our ability to execute and to continue to deliver transformational medicines to patients.
As a leader, I have always believed that culture matters. At MGH and at Yale, I worked hard to build a patient-focused research environment. Ever since I joined BMS as a director, I knew the company had a patient-centered focus. But as I've been meeting more and more people in this role, I've been struck by just how patient-focused the mission is here. In every meeting, we hear the patient voice. Our research teams are driven to improve the lives of people with cancer, heart disease, fibrosis, and rheumatologic diseases.
There are some key capabilities that I will look to build in the coming months. These will focus on three principal areas. First, we will enhance our translational medicine capability. Biomarker development to select the right drug for the right patient at the right time is key.
Second, we will invest in cancer biology. Translational medicine starts with fundamental research. And the scale of our pipeline demands that we have the best understanding that we can of our patients and of their diseases.
Third, we will invest in data and analytics. We are at an inflection point as a society and as an industry. In order to execute our pipeline of about 20 oncology assets, 20 cardiology, immuno-science, and fibrosis assets, 15 compounds in preclinical development, and nearly 80 programs in discovery, we need to enhance our analytic capacity to execute this pipeline with deliberate speed.
In addition to what we do at BMS, we will pursue strategic external collaborations to help meet these needs. Some recent examples include the expansion of our international immuno-oncology network and new collaborations with the Parker Institute, Foundation Medicine, and GRAIL. Working together will enable us to move even faster and to identify patients most likely to benefit from our medicine. This is not just good to do scientifically, but it's good for patients and is what payers and regulators expect.
As a cancer researcher and through my experience running the Massachusetts General Physician Organization, I know that it's impossible for one company or institution to do it all. And given the fast pace of scientific innovation happening today, collaboration across the entire healthcare ecosystem is becoming increasingly important.
In the near term, my most important priorities for the R&D organization include the four areas; first, accelerating the delivery of our next wave of I-O assets like IDO, which we recently presented data on at AACR. We'll also be presenting early results for LAG-3, GITR, and the Incyte IDO at ASCO this year.
Second, understanding the biology of I-O resistance, both intrinsic resistance and acquired, and bringing a laser-like focus to overcoming this. We will focus on expanding into tumor types where I-O hasn't had a broad impact yet, tumors like breast cancer, colorectal cancer, and prostate cancer. We will use our next-wave assets to create options for patients who progress on their initial I-O therapy.
Third, we will continue to develop combination regimens, including I-O/I-O combinations, I-O/targeted combinations, and I-O/chemotherapy combinations where these make sense.
And fourth, we will accelerate the development of our most promising assets in the cardiovascular, immuno-science, and fibrosis pipeline. As Giovanni mentioned, we recently presented promising Phase 2 data on our FGF21 asset in patients with NASH at the International Liver Congress. The results showed an improvement across multiple aspects of NASH, including a significant reduction in liver fat versus placebo. And we look forward to sharing these data with the health authorities.
In closing, BMS has accomplished much in the last five years, but its true impact lies ahead. I'm excited about the opportunities and proud to lead an R&D organization that is focused, science-oriented, and data-driven, and one that is driven to deliver medicines that have the potential to transform the lives of our patients.
I'll now turn it over to Charlie.
Charles A. Bancroft - Bristol-Myers Squibb Co.
Thank you, Tom. Good morning, everyone.
As Giovanni described, we delivered very strong financial results for the quarter due to robust performance across our portfolio. Let me provide some color on the performance of our key products.
I'll start with Eliquis, which for the first time sold over $1 billion in a single quarter. In the U.S., Eliquis is now the leading agent in the NOAC class, which continues to grow as warfarin use declines. During the quarter, sales in the U.S. were driven by a sequential 8% increase in TRx and from the positive impact of lower Medicare coverage gaps compared to Q4 of last year. Internationally, Eliquis delivered strong growth of 51% compared to the same time last year, as the gains in established position as the standard of care in stroke reduction for AFib around the world.
Sales for Opdivo in the U.S. increased 6% sequentially, driven by the demand growth that Giovanni described and some favorable inventory movement compared to Q4. We continue to expect our U.S. lung business to be under pressure this year assuming KEYNOTE-021G is approved next month. However, given the stability in second-line lung in Q1 and strong trends we've seen across other indications in our U.S. business, we now believe that there is potential for Opdivo to grow in the U.S. this year compared to 2016.
During Q1, we saw sequential growth in international Opdivo sales when adjusting for the approximately $250 million revenue recognition catch-up for France and Germany we booked in Q4. We successfully negotiated reimbursement for Opdivo in several markets during the quarter, including a pan-tumor agreement in Canada as well as agreements for renal cell cancer and non-squamous-cell lung cancer in Italy. Based on positive sales trends and reimbursement successes, we continue to expect international sales for Opdivo to grow for the full year.
Additionally, we saw Yervoy return to growth in international markets during the quarter, as access and reimbursement approvals for the regimen facilitated greater adoption.
Orencia also delivered double-digit growth, with solid underlying brand trends as we continue our commercial focus on the early rapidly progressing RA patient. U.S. sales in the quarter were up 13% despite unfavorable inventory movement.
In addition, as we've seen in other years during Q1, we saw softer demand in the subcu [subcutaneous] market at the start of the year, which we believe is due to coverage resets early in the year.
Now I'd like to highlight a couple of items from our non-GAAP P&L. Gross margin was down 160 basis points compared to the same time last year, driven mainly by product mix, though this was partially offset by FX due to recognition of hedge gains and favorable FX on inventories from Q4. Going forward, we expect the continued strength of Eliquis and decline of our high-margin virology business to pressure our gross margin.
Other income and expense is down by approximately $72 million versus prior year, primarily due to the change in the tiered AZ diabetes royalty rate last year to a flat 12% this year. This was partially offset by our accrual of PD-1 royalties from Merck in Q1 of $30 million.
We continue to take a balanced approach to capital allocation, with business development remaining a top priority. As Giovanni mentioned, this quarter reflected a significant level of strategic activity to support our immuno-oncology pipeline and translational capabilities. We executed multiple transactions since our last earnings call, spanning investments and collaborations with biotech and academic partners, adding registrational clinical opportunities and capabilities in diagnostic platforms and genomic profiling that strengthened our pipeline and our capabilities in translational medicines.
In addition, we delivered against our new share repurchase authorization with a $2 billion ASR in February, and we plan to begin repurchase activity under a 10b5-1 program once the ASR process completes by the end of the second quarter.
I'll now provide some comments on guidance. Based on our strong performance, we are increasing our non-GAAP EPS guidance range to $2.85 to $3.00. As always, this range assumes current foreign exchange rates. We are increasing revenue guidance to the mid-single-digit range due to the strong trends across the business, particularly our key products, Opdivo, Eliquis, and Yervoy. As I mentioned, gross margin saw some FX favorability in Q1. However, at current rates, we expect margins to decline as the year progresses and continue to see our rate in the 72% to 73% range for the year.
For R&D, we are now expecting an increase in the low double-digit range, as we see opportunities for slightly higher investment across our portfolio, including some of the new clinical collaborations I mentioned earlier.
As Giovanni said, we had a very strong quarter from a financial and operational perspective. We continue to pursue important opportunities in our pipeline, both in I-O and in our specialty portfolio, and we are committed to putting resources where we can deliver the greatest value.
Now let me turn it back to John to kick off the Q&A.
John E. Elicker - Bristol-Myers Squibb Co.
Okay, thanks, Charlie. So we're ready to go to questions, Melody. We can go ahead and start.
Question-and-Answer Session
Operator
Thank you. And we'll go to our first caller.
John E. Elicker - Bristol-Myers Squibb Co.
I think the operator is not going to announce the callers. So once you get prompted, if you can, go ahead and introduce yourself.
Operator
And, caller, your line is open. Please check your mute function. With no response, we'll move to the next caller. Next caller, please go ahead.
Christopher Schott - JPMorgan Securities LLC
Hi there. It's Chris Schott at JPMorgan. Can you guys hear me?
John E. Elicker - Bristol-Myers Squibb Co.
We got you fine, Chris. Thanks.
Christopher Schott - JPMorgan Securities LLC
Okay, perfect, just two questions here, maybe the first one for Giovanni and for Tom, just a question on lung and this ongoing debate around I-O/I-O versus I-O/chemo combinations. I think one of your competitors today announced that they're also going to be looking at chemo combos with PD-1 in addition to their I-O/I-O combos. I'm just interested in your latest thinking on the role you see chemo playing in this I-O landscape relative to CTLA-4 and some of the other next-generation agents you're developing.
My second question was specifically on IDO and just more thoughts there on IDO as a combination agent and your approach to this target as you balance your internal asset versus the external partnership. So just any more color there would be helpful; and maybe as your answering that, just latest timelines on when we could potentially think about that internal asset moving forward into registrational studies. Thanks so much.
Giovanni Caforio - Bristol-Myers Squibb Co.
Thank you, Chris. This is Giovanni. Let me just start, and I'll ask Tom to comment on both of your questions. On lung strategy, as you heard from me and Tom, we are very comfortable with the fact that we have a very broad approach to first-line lung cancer, a very broad program. We are indeed investigating various treatment modalities, including I-O/I-O, I-O/chemo, and as you know, potentially the combination of the two approaches with I-O/I-O coupled with chemotherapy. And I am pleased that over just a few months, we have been able to evolve our lung cancer program, taking advantage of ongoing studies and that enrollment has progressed I would say very much in line with our expectations.
With respect to IDO, the one thing I would say at a very high strategic level is that we see really promising modalities. I think the ability to complement external collaborations as we advance internal programs provide, again, in the same spirit, a very broad set of options for us in order to be competitive from a timing perspective at the same time as we develop potentially best-in-class. But let me ask Tom to give you his comments on both.
Thomas James Lynch - Bristol-Myers Squibb Co.
Chris, thank you for your questions. And I just want to start by saying lung cancer is a really hard disease to treat. And you don't need to go any further than this morning's New England Journal, the paper by Charlie Swanton's group looking at the genomic diversity of this disease, both within tumors and between tumors. It's a tough disease to treat. And we believe it's important for us to have multiple approaches to treating patients with non-small-cell lung cancer. We think the approach at Bristol-Myers Squibb that includes I-O/I-O and I-O/chemo and I-O/targeted drugs gives us a broad and diverse and balanced approach to how we're going to go after lung cancer. And I think that there may well be certain patients that are going to benefit from I-O monotherapy, I-O/I-O, and I-O/chemotherapy. I don't think there will be a one-size-fits-all approach to this disease.
I want to comment on CTLA-4 and how important a target this is in lung cancer and other cancers as well. CTLA-4 I think has been validated as an important partner with Opdivo. Just look at our data in melanoma and the CheckMate-067 study, which showed that we actually have a survival advantage, the only I-O/I-O combination that's been shown to have a survival advantage. And we think CTLA-4 matters in this disease and requires investigation.
I think just to show you how deep our commitment to CTLA-4 is as an agent, we have two additional compounds with CTLA-4 that we're developing as targets. The first is the non-topopulated (25:47) CTLA-4, which is now entered into clinical study. There's a trial that we describe on ClinicalTrials.gov that you can take a look at. And our relationship with CytomX has developed the CTLA-4 compound as a Probody that we think might have a different toxicity profile with this agent. So we believe it's important for Bristol-Myers Squibb to be looking at CTLA-4 as an important target.
Now, that doesn't mean that next-gen agents aren't important, and you mentioned IDO. This is target that Bristol-Myers Squibb is intimately involved with in two ways. Last year, we went out and we purchased Flexus and we acquired the IDO compound. And at ASCO, we presented data on our IDO with Opdivo, which we think gives us a compound that may be differentiating. It gives us a PKBD (26:38) profile that may well describe an opportunity for us to have a unique place in the marketplace. And this year at ASCO, you're going to see data on the Incyte IDO along with Opdivo in important settings. And we plan by the end of this year to begin randomized Phase 3 trials of the Incyte IDO with Opdivo in lung, head and neck, and melanoma.
So, Chris, I think it's important to say that we're committed to CTLA-4, and we also think that IDO and our next-gen agents are also important to develop in lung cancer. It's a complex marketplace when you develop the right drugs for a very broad and diverse group of patients.
John E. Elicker - Bristol-Myers Squibb Co.
Thanks, Chris, for the question. Melody, can we go back to the first group in the queue? I got an email from the team at Barclays saying that they were having trouble recognizing that they were up. So I don't know if it's Geoff Meacham or Paul Choi, but could you go to them please again?
Operator
Yes, definitely, just one moment. And, Mr. Meacham, your line is now open.
Geoffrey Meacham - Barclays Capital, Inc.
Okay, great. So thanks a lot for the question. It seems the biggest opportunity longer term in I-O is really the cold tumors, breast, ovarian, colon, et cetera. To follow up on the earlier comment, CTLA-4 combos, do you guys feel at this point CTLA-4 combos plus a PD-L1 is going to be a component of that? Are there other targets across the I-O landscape and many different targets that look more viable in cold tumors versus hot? Thank you.
Thomas James Lynch - Bristol-Myers Squibb Co.
Geoff, thanks for your question. I think this echoes what I mentioned earlier, the concept of looking at resistance. Resistance is incredibly important, and it's really characterized a lot of oncology drug development. Just looking at where your drugs don't work tells you as much as you learn from looking where your drugs do work. What I explained earlier and outlined is the two areas I'm most worried about in terms of resistance – or think of as actually opportunities is what about the cold tumors that don't respond, and then what about the patients who have initial response to anti-PD-1 or anti-CTLA-4 therapy who then progress?
Now, as you know, we have 10 targets in I-O that we're working on and 12 agents in those 10 targets. So we think we have multiple opportunities to look at combinations of I-O/I-O agents in these cold tumors. We presented data with our IDO asset, as you mentioned, and we also will be presenting data, initial data at ASCO this year with our GITR compound, which could be the type of agent that might play a role in the cold tumor space. But we will increasingly look at combinations of agents in that setting that might make a difference.
John E. Elicker - Bristol-Myers Squibb Co.
Thanks, Geoff. Melody, can we go to the next question? And if you have it in front of you, could you announce them on the line so that they know they're ready to go? Thank you.
Operator
We'll go next to Gregg Gilbert with Deutsche Bank.
Gregg Gilbert - Deutsche Bank Securities, Inc.
Thank you for that double prompt. Maybe, Tom, here's an opportunity for you to straighten us out of the timing of CheckMate-227. Whether it's final or interim, that would be helpful. And curious, Tom, if you have a view on whether PD-1s and PD-L1s can be different from one another other than by trial design strategy.
And one for Giovanni real quick, in light of the activist investor interest and significant change in the board, I'm curious if you can comment on what's changed in terms of how you're spending your time, the company strategy, options you're exploring to enhance value. Or do you see this as business as usual stuff? Thanks.
Thomas James Lynch - Bristol-Myers Squibb Co.
Gregg, thank you for your questions. I'll start off by commenting on the timing of CheckMate-227. As we have published on ClinicalTrials.gov, we expect the data from CheckMate-227 to report in the first half of 2018. And as we also have announced, there will be an interim look, and we'll look at that data with our data safety monitoring committee as the data matures. But we expect the data to be the first half of 2018.
So the second question comes down to differences and similarities between PD-1 drugs. And I think my feeling is that I think there's highly likely to be much more similar between these drugs than there are going to be differences. Now we know, for example, that pembro [pembrolizumab] and nivo [nivolumab] recognize slightly different epitopes and there are slight differences in these compounds. But clinically when you look at the totality of the data, they really behave fairly similarly to each other. So I actually don't think we're going to find enormous differences between the various different PD-1 drugs.
Now the difference between PD-1 and PD-L1 agents, certainly there's a possibility that there will be more information. We're looking out on that, and I remain open to looking at the data as it emerges across that area. Giovanni?
Giovanni Caforio - Bristol-Myers Squibb Co.
Gregg, thank you. So from my perspective, let me say that I'm really very happy with the ability that we have to have broadened and strengthened the capabilities on the board. That's clearly very important for a company like ours.
With respect to what our priorities are, they really have not changed. We are, as you have seen today, extremely focused on continuing to execute as well as we have for the short term. And we are extremely focused and I am extremely focused on delivering the value of an extraordinarily promising pipeline, which is probably the broadest and the deepest the company has had. So that's where we are spending our time. Those are our priorities, and clearly they are mine as well.
John E. Elicker - Bristol-Myers Squibb Co.
Thanks, Gregg. Melody, can we go to the next question, please?
Operator
Certainly, we'll go to Tony Butler with Guggenheim Securities.
Charles Anthony Butler - Guggenheim Securities LLC
Yes, good morning. Thank you very much, two brief questions. One, if I may around Eliquis, tremendous number for the quarter, but the COMPASS data will read out later this year at European Heart [ESC]. And I'm curious if it does possibly have an effect on the NOAC class as a whole. Or could it be viewed somewhat negatively for Eliquis at least in CAD/PAD? And that is does the class actually increase, or is this just dependent upon – or do we single out rivaroxaban?
And then secondly, Charlie, an excellent gross margin quarter, but the question really is, how should we think about that going forward in the year? They bounce around little bit, at least they had last year. This is clearly a change from what we've seen in the last two years. Thanks for the time.
Murdo Gordon - Bristol-Myers Squibb Co.
Thanks, Tony. It's Murdo here. I'll address the Eliquis question and pass it over to Charlie for your second part. First off, we're really pleased with the Eliquis performance in the quarter and continuing what was a great year last year. As Giovanni mentioned, total prescriptions, now we're in a leadership position in the NOAC class. And we continue to feel good about growth based on leading indicators that we look at in the market, which are NBRx trends as well as our cardiology trends. We're also seeing strong performance across the rest of the world.
Now as I think about the COMPASS trial, it's actually an interesting question. And obviously, without data, it's hard to speculate. What I do see happening though is a continued strength of our profile and the divided daily dose of Eliquis in atrial fibrillation and VTE. What we need to wait to see is the quality of the COMPASS data at a different dose that Xarelto used in that trial versus the dose that they currently use in VTE and in atrial fibrillation. So it's hard to compare the COMPASS data to any of the data that exist already in the marketplace.
And then the other question remains is what's the utility of a NOAC versus antiplatelet drugs in the patient population that was studied in the COMPASS trial? So I probably have some more questions related to that trial than I have answers, but we do not see it impacting our AF and VTE business going forward.
Charles A. Bancroft - Bristol-Myers Squibb Co.
Hey, Tony, it's Charlie. Let me address your margin question. As you know, our gross margin is heavily influenced by product mix, with Eliquis, given the structure of our relationship with Pfizer, having a lower than 50% margin. So the growth of Eliquis with the loss of our higher-margin virology business has put pressure on our gross margin. So the uptick that we saw in the first quarter is almost solely due to foreign exchange when we think about it exiting out of the fourth quarter of last year, and that's more of a one-time impact that we see in the first quarter and not really repeating for the balance of the year.
John E. Elicker - Bristol-Myers Squibb Co.
Thanks, Tony. Melody, can we go to the next question, please?
Operator
Certainly, we'll go to Seamus Fernandez with Leerink.
Seamus Fernandez - Leerink Partners LLC
Thanks very much. Can you hear me okay?
John E. Elicker - Bristol-Myers Squibb Co.
Yes, Seamus, we've got you.
Seamus Fernandez - Leerink Partners LLC
All right, great, so a couple of quick questions. Can you guys talk a little bit about how in the wake of the settlement with Merck, how you plan to prosecute your rights around the patent estate that you've built up around PD-1? Obviously, it was successful with Merck, but they had a different time-to-market and there are many, many other PD-1s out there. So just wondering how aggressive you feel that you can be as a company, or if you think that that's not a value-added strategy.
And the second question really is, I look at the trends on Eliquis and the still overall market opportunity with the substantial amount of warfarin out there. This feels like it could be well more than a $10 billion category. In fact, Eliquis may have an awful lot of runway ahead of it, particularly given your opportunity to extend the patent. So I just wanted to get a better sense of how much incremental opportunity you think there really is to grow the category in the U.S. and internationally. Thanks so much.
Giovanni Caforio - Bristol-Myers Squibb Co.
Thanks, Seamus. This is Giovanni. So let me start, and then I'll ask Murdo to give you his comments on Eliquis. So first on the settlement with Merck, we think that is an extremely important recognition the strength of our IP estate with respect to immuno-oncology and PD-1s. And I think that settlement is critically important, but also it reinforces our perspective that we will continue to vigorously defend our IP across the board, and that clearly is a priority for the company. It has not changed. If anything, it actually has become stronger post the settlement with Merck.
Let me just also say that we also are very focused on Eliquis, and we agree with the significant long-term potential there is in this market. And I'll ask Murdo to comment on that. Obviously, before I do that, let me just get back to the IP. It's clearly an important priority for us. It's also one that we share with our partner, Ono, and we are working very closely with Ono on any IP-related issue. Murdo, on Eliquis?
Murdo Gordon - Bristol-Myers Squibb Co.
Thanks, Giovanni. Thanks, Seamus. We're also, as Giovanni said, we're very enthusiastic about the trajectory of Eliquis so far, and we're working closely with our partners at Pfizer to capitalize on the untapped opportunity that still exists in the market. As you mentioned, over half of the TRx business is still a warfarin-based treatment patient population. And if you look at the leading indicators, new-to-brand shares, warfarin is about 27% of the OAC [Oral Anti-Coagulant], so still a good delta to capitalize on in terms of leading indicators. We continue to invest appropriately in Eliquis.
The other thing I would mention is, outside of the U.S., in some markets around the world, the NOAC class is even more underpenetrated in the market. So when you combine the U.S. opportunity and the European opportunities, we continue to feel that there's a large growth trajectory and a high ceiling for that brand.
John E. Elicker - Bristol-Myers Squibb Co.
Thanks, Seamus. Melody, could we go to the next question, please?
Operator
Certainly, we'll go to Tim Anderson with Bernstein.
Timothy Minton Anderson - Sanford C. Bernstein & Co. LLC
Thank you, a couple of questions. If I look at the totality of things that have happened over the last call it six months, including programs you've advanced like IDO and chemo combo and backup CTLA-4s and other things like that, a bear's point of view could say that this foretells problems with Yervoy and Opdivo, specifically in front-line lung. So my question is can you say you're as confident as ever in the possibility that CheckMate-227 is going to deliver the goods in this regard in front-line lung, or is it fair to say that Bristol's internal confidence in this is less than what it was perhaps a year ago?
And then the second question is still on CheckMate-227. There have been some rumblings about additional changes potentially to the construct of that trial above and beyond what you talked about earlier. I'm wondering if you can just clarify whether any of this is correct since the latest updates that we've had. And this includes things like expanding various arms to new subgroups and timelines for readouts and sizing up the trial and that sort of thing.
Giovanni Caforio - Bristol-Myers Squibb Co.
Tim, thank you. This is Giovanni. Let me just start. So obviously, a lot has happened in the last 6 to 12 months in first-line lung cancer. As I said earlier and Tom reiterated, this is a very difficult disease to treat. It has evolved very rapidly. You just think of the data that was released in the last 12 months, and it's clear that our competitive position has changed and continues to evolve. My perspective is that today we have the broadest program for first-line development for our immuno-oncology portfolio in lung, and we are extremely focused on executing that program. Execution is on track, and I'll let Tom answer you with respect to study design.
Thomas James Lynch - Bristol-Myers Squibb Co.
And, Tim, thanks for your question. I think a couple things to say. I think the first is that again, just emphasizing how complex and difficult a disease lung cancer is to treat, it's highly unlikely that there's going to be one approach that's going to fit every patient who presents in first-line. We believe strongly that Yervoy/Opdivo is certainly one of the options that needs to be pursued and developed, and we're looking at that in first-line lung cancer. And we're also looking at it in the setting of what appropriate biomarkers might be important in evaluating the potential for this combination and for really all of our drugs in first-line lung cancer. So I think that's important to emphasize.
The second question you asked was about changes to CheckMate-227, and there have been no changes to CheckMate-227. The design is the same design as it was the last time it was discussed.
John E. Elicker - Bristol-Myers Squibb Co.
Thanks for the questions, Tim. Can we go to the next question please, Melody?
Operator
Yes, we'll go to Jami Rubin with Goldman Sachs.
Jami Rubin - Goldman Sachs & Co.
Thank you, a couple questions, and maybe, Murdo, you can answer this first. CheckMate-067 at AACR generated more questions about the combo than answers. Do you see the results leading to an increase in market share for the combo in melanoma or a decrease? And following up on data that came out at AACR, there was an interesting study that showed high tumor burden as a marker of success for PD-L1. I just was wondering if you were able to adjust CheckMate-227 to account for this new learning, if at all.
And then lastly for you, Tom, and I appreciate your introductory commentary on your priorities. That's very helpful. Just wondering though, you have been on the board for two, three years, and I appreciate you've only been in this position for a couple months, but just curious to know what sort of changes you have thought about putting in place. What are you planning to do differently compared to the former head of R&D? For example, are there plans to change the way that you go about study designs?
I think initially Bristol's focus had been on creating high-value trials showing overall survival. Those trials certainly make a lot of sense, but not when your competitors are trying to beat you to the market. So I'm just wondering if you are changing the way you approach some of these clinical trial designs. Do you have the right people in place? Do you have the right regulatory people in place just compared to where the priorities were before? Thanks very much.
Giovanni Caforio - Bristol-Myers Squibb Co.
Thanks, Jami. Murdo, why don't you start?
Murdo Gordon - Bristol-Myers Squibb Co.
Sure, thanks for the question, Jami. On CheckMate-067, first off, I thought Dr. Larkin did a great job presenting these important data from CheckMate-067. And as Tom mentioned, the first overall survival data set we have with an I-O/I-O combination. We have been out obviously getting feedback from customers in the U.S. and around the world, and I would say that the data have largely been viewed positively as confirmation of the effectiveness of Opdivo plus Yervoy in this patient population. I would agree with you. There are more questions that still people have because everybody is trying to segment patients in first-line metastatic melanoma, and we continue to work with physicians and investigators on the trial to answer those questions as best we can.
I will say, for those physicians who have used the regimen and continue to believe that they're getting the best results possible in terms of response rates or overall survival in metastatic melanoma, this data set confirmed that belief. I would say for those physicians that were skeptical or overly concerned about the toxicities, and the toxicities are significant, we recognize that, but we're able to help most experienced treaters through the toxicities, and we're able to help them also discuss them with their patients. For some of those physicians, they remain, I would say still concerned about the balance of efficacy and safety, particularly in the high expressers.
Now there are other descriptive analyses that have been completed, and I will remind you obviously it's hard to compare the active treatment of the combination to PD-1 monotherapy because the study wasn't powered to do that, so people are inferring from the data set certain things that we've yet to statistically prove. But we have seen also some good descriptive results in BRAF mutant patients where the combination of Opdivo plus Yervoy looks particularly good. So there's a lot still to unfold here, but nonetheless, my summary to all of that is net positive. Thank you.
Thomas James Lynch - Bristol-Myers Squibb Co.
Jami, Tom Lynch here, so a couple things. First, you have two questions I'll address. One is the mutational burden question. The second are the changes within the R&D organization.
So regarding mutational burden, I think this is a great example of data that we're very excited about. As you know, when we went back and looked at CheckMate-026 and we found that when we stratified patients by mutational burden, we saw that the response rate was superior for nivolumab versus chemotherapy. But it's early data and it's going to require confirmation in larger data sets and it's going to require more evaluation to have a sense of what its ultimate role is.
What I really want to stress is how difficult it is to develop the appropriate biomarkers. And just think about a drug like trastuzumab. And when we started developing trastuzumab, we thought that expression of immunohistochemistry of HER-2 was going to be the ultimate marker. It turned out to be HER-2 amplification that was the marker. Think about the development of erlotinib and gefitinib. We thought it might be expression by IHC. We then thought it was going to be amplification. It turns out it was EGFR mutation that was the most important. And then also think about siltuximab and its development in colorectal cancer. It wasn't EGFR expression, it turned out to be RAS mutation. So these are all very complex areas that require a very committed and disciplined approach to biomarker development.
So the second question you asked comes down to the changes within R&D. I want to just start off by saying, and I emphasize what I said in my opening remarks, is that the quality and depth of the people and the talent at Bristol-Myers Squibb in R&D I think is exceptional. We have 11 approvals in two years of I-O agents. That is an extraordinary track record. I think the execution of our regulatory team in particular is one that is beyond reproach. And I would say, I tell Giovanni, I said this is an example, I said it's the kind of execution even Tom Brady would be impressed with.
However, what are our opportunities for moving forward and thinking about how we can do even better? And that's really where I think we have a couple of key priorities. The first is we've got to execute our pipeline. We've got to develop our next-generation drugs. And to do that, we're going to need to invest in tumor biology and translational medicine as well as data and analytics. The pipeline is not going to develop itself. It's going to need us to look at the totality of what we have and understand the best combinations to put together, and I think that's going to be a very important part of what we are going to do.
So again, translational medicine, investing in more cancer biology; and then again I keep coming back to the data and analytics piece and our relationships with GRAIL and Flatiron and looking at how can we look at a complex portfolio, not just in cancer, but also immuno-science, fibrosis, and cardiology, to be able to execute this pipeline in a reasonable timeframe.
John E. Elicker - Bristol-Myers Squibb Co.
Thanks Jami. Melody, can we go to the next question, please?
Operator
Yes, we'll go to Alex Arfaei with BMO Capital Markets.
Alex Arfaei - BMO Capital Markets (United States)
Thank you for taking my questions and congratulations on a great quarter. Sorry if I missed this earlier, but was there any inventory or deferred revenue impact on your I-O franchise, particularly in Yervoy? I'm just following up on an earlier question. How should we think about the patent life for Eliquis in major markets? Thank you.
Charles A. Bancroft - Bristol-Myers Squibb Co.
This is Charlie. As I mentioned in my comments, in the fourth quarter of last year, we booked the deferral that we had on our books from France and Germany. That equaled about $250 million. So that happened. When you look fourth quarter versus first quarter, we did have that one recognition last year. We did see some slight inventory builds for both Opdivo and Yervoy in the U.S. Opdivo was about $30 million, and for Yervoy about $20 million.
Giovanni Caforio - Bristol-Myers Squibb Co.
And with respect to your question on Eliquis patents, so our composition of matter patent expires February 2023. We have a pending request for restoration of patent terms which goes until November of 2026.
John E. Elicker - Bristol-Myers Squibb Co.
Thanks, Alex. Melody, can we go to the next question, please?
Operator
We go to David Risinger with Morgan Stanley.
John E. Elicker - Bristol-Myers Squibb Co.
Dave?
David R. Risinger - Morgan Stanley & Co. LLC
Sorry, I was on mute, my apologies. So I have a few questions for Tom please, and congratulations on your new role, Tom. With respect to the first one, that is Opdivo's chemo lead-in strategy to enhance Opdivo's performance in lung cancer is something new. Could you talk about that a little bit more?
And then second, with respect to the forthcoming MYSTIC trial readout this summer, I guess what would you focus Bristol-Myers investors on when we're looking at those MYSTIC study results and thinking about cross-trial implications for CheckMate-227?
And then finally, I think you had mentioned that in the first half of 2018 you'll have the CheckMate-227 results. But CheckMate-227 is a very complex study with three segments. Do you expect all three segments to be reporting in the first half of 2018? And also, what is the interim look in the fourth quarter of this year? Is that just in the positive cohort? Thank you.
Giovanni Caforio - Bristol-Myers Squibb Co.
Thanks, David. Let me just start by giving you our perspective with respect to your question on MYSTIC. And as we've commented before, these are different trials with different molecules and different study design. We've actually I believe really worked hard to optimize dosing and schedule. So it's very difficult to really speculate on any implications on the results of one study versus the other. Now I'll ask Tom to answer your question with respect to chemotherapy and then provide some context on timing for CheckMate-227.
Thomas James Lynch - Bristol-Myers Squibb Co.
Thanks, Dave. So regarding the rationale for looking at Opdivo in chemotherapy, I like to think that there might be two ways that this could be helping in this. As you know, chemotherapy has been the backbone of how we've treated lung cancer for the past 30 years. And in studies, and again it's not just with I-O, but it's also looking at targeted agents. There may be a rationale for the fact that the rapid progressors might be better suited by getting chemotherapy on board early, that there may be some rationale for that. The second thought is perhaps the addition of chemotherapy to I-O agents could help to create a more favorable environment for immune recognition and activation of the immune system.
So I think there are good rationales for looking at chemotherapy with Opdivo, and I think one of the things that we're very interested in is how the combination of Opdivo, Yervoy, and chemotherapy performs. And we'll be looking at that quad combination to see where that might fit into the treatment of patients with non-small-cell lung cancer.
Regarding the timelines, obviously, these patients were accrued to the different portions of the trial at different times. I don't anticipate that we would have all of the data in the first half of 2018. As you know, this is an event-driven world that we live in, in these trials and that we're going to need to see how the data matures. But we do hope to have the first data in CheckMate-227 at that point. Thanks.
John E. Elicker - Bristol-Myers Squibb Co.
Thanks, Dave. Melody, can we go to the next question, please?
Operator
We'll go to Andrew Baum with Citi.
Andrew S. Baum - Citigroup Global Markets Ltd.
Thank you, a couple of questions, please. Just continuing on the theme of chemo at your CheckMate-568 trial, if I were to ask you whether your intended rationale by combining chemo with dual checkpoint blockade is simply addition or some form of immunopotentiation, I'd be interested in your current thesis.
Second, you mentioned Charlie Swanton's papers recently published, where he clearly showed that chemo increases subclonality, and thus may actually impair subsequent long-term outcomes arguing against increasing chemo as first-line. Do you think there is merit to that hypothesis?
And then finally, I noted you had started a fairly substantial Phase 1 trial with your next-generation CTLA-4. I know you consolidated (55:53) serotonin, presumably enhanced T-REG depletion. I know that that mechanism has been downplayed by Bristol as being contributing to Yervoy's efficacy. I'm just interested in whether there's a rethink of that and obviously the implications given the other CTLA-4 molecule in Phase 3 trials. Thank you.
Thomas James Lynch - Bristol-Myers Squibb Co.
So, Andrew, thank you for your questions. I'll break them down into the three parts. The first is the rationale behind CheckMate-568, whether it's due to addition basically of the two mechanisms versus whether it might be more immunostimulatory. Again, I think that there might well be arguments you can make in both respects, and I keep an open mind to both of those. And I indicated that in response to Dave's question earlier. So I actually don't know which of those two is going to turn out to be most important.
I think again with regard to Charlie's work on the complexity, the genomic complexity and heterogeneity within tumors, I do think we need additional time to see how this plays out in terms of understanding how this impacts the therapeutic classes that we use. And again, I await the collaborations that we'll be doing to look at those endpoints.
And finally on CTLA-4 and our next-gen areas, I think that T-REG depletion still is a valid endpoint in developing I-O agents. Whether it's the principal activity of CTLA-4 or not I think is something that is an open question. But among our agents that we're developing in I-O, we have multiple drugs that we think have as part of their mechanism depletion of T-REGs. So I do think that there is potential for T-REG depletion to be important in the activity of I-O agents in our next-gen compounds as we bring them forward.
John E. Elicker - Bristol-Myers Squibb Co.
Thanks, Andrew. Melody, I think we have time for one more question.
Operator
We'll go to John Boris with SunTrust.
John T. Boris - SunTrust Robinson Humphrey, Inc.
Thanks for taking the questions and congrats on your new role, Tom. First question for Murdo, just if you look at Opdivo's use currently, what percent is coming from lung, melanoma, renal, and if we can get a split in lung, in particular in first-line versus other line use in the U.S.?
The second question has to do with the use of the diagnostic for PD-L1 testing. It seems as though many centers have gone to an exclusive use of testing, and a very high percentage of the centers are now testing. Just any thoughts on how that may shape the landscape, especially as Merck is attempting to pivot into first-line lung use?
And then third and final question on the FGF21, just your thoughts, Tom, around single-agent use in fibrosis and NASH versus combination use. So one of the major competitors that has farnesoid X antagonists has certainly moved very aggressively on developing relationships and combination relationships with both the Tobira and Addis assets to maximize efficacy in this area. Just your thoughts and your openness on the importance of combination relative to single-agent therapy would be helpful.
Murdo Gordon - Bristol-Myers Squibb Co.
John, I'll address your question on testing first. Basically, what we're seeing in first-line is about 80% of patients are receiving a PD-L1 test. It is becoming, I think as you mentioned, a standard practice, and we continue to feel that that will happen in markets outside the U.S. as well as testing proliferates. So all new early diagnosed first-line lung cancer patients will have a PD-L1 result.
In terms of Opdivo use overall, we've been very pleased. I think the team in the U.S. as well as the teams around the world have done a great job both defending competitively as well as establishing the launch trajectory of Opdivo. And right now in the U.S., about 55% to 65% of our total business is in lung, all lines and non-small-cell lung cancer all lines. And when you go worldwide it's higher than that given that we have a significantly lead over Keytruda.
Thomas James Lynch - Bristol-Myers Squibb Co.
So, John, thank you for your questions about FGF21. I'd be delighted to have a chance to offer some thoughts on this. We're very excited about FGF21 because it's the first of our agents to come forward from looking at fibrosis and NASH, and we think this drug has a number of favorable features about it. It impacts the metabolic drivers, fat accumulation. It has anti-inflammatory properties, and we also believe it's going to impact fibrosis within the liver itself.
And when you think about the kinds of patients who get NASH, these are patients who are dealing with obesity, patients who are dealing often with diabetes, metabolic syndrome. It's a difficult group of patients to treat. And so how we develop these drugs, whether they're single agents or combinations, I think a key look at side effect profiles, at lipid profiles, at making sure that we're able to achieve endpoints that are meaningful, meaning reduction in fibrosis ultimately, I think will be the ultimate goal.
Whether it's a single agent or combination, I obviously remain open to both opportunities. I think there are reasons to think our drug might work as a single agent. However, I think it would be important for us to also consider what combination therapy in the future might look like in this setting. It's an important unmet medical need that we are very happy to be able to offer some options for.
Giovanni Caforio - Bristol-Myers Squibb Co.
Thank you, Tom. Again, we are in a very strong position financially, commercially, clinically, and I believe we are well positioned to continue to grow the company and play an even more important role in the lives of our patients. Thanks, everyone.
John E. Elicker - Bristol-Myers Squibb Co.
Thanks, everybody. This concludes our call. As always, if you have any follow-ups, give us a call or shoot us an email. Thank you.
Operator
Ladies and gentlemen, again, that does conclude today's conference. Thank you all for attending.
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Bristol-Myers Q1 top line up 12%; Opdivo sales up 60%; earnings up 32%; EPS guidance raised; shares ahead 4% premarket
Apr. 27, 2017 8:44 AM ET|About: Bristol-Myers Squibb C... (BMY)|By: Douglas W. House, SA News Editor
Bristol-Myers Squibb (NYSE:BMY) Q1 results ($M): Total Revenues: 4,929 (+12.3%); Product Sales: 4,580 (+15.5%).
Net Income: 1,574 (+31.7%); Non-GAAP Net Income: 1,400 (+13.4%); EPS: 0.94 (+32.4%); Non-GAAP EPS: 0.84 (+13.5%).
Key Product Sales: Opdivo: 1,127 (+60.1%); Eliquis: 1,101 (+50.0%); Orencia; 535 (+12.6%); Sprycel: 463 (+13.8%); Yervoy: 330 (+25.5%); Hep C Franchise: 162 (-62.1%).
2017 Guidance: Revenue growth: mid-single digit; EPS: $2.72 - 2.87 from $2.47 - 2.67; Non-GAAP EPS: $2.85 - 3.00 from $2.70 - 2.90.
Shares are up 4% premarket on increased volume.
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https://seekingalpha.com/news/3260640-bristol-myers-q1-top-line-12-percent-opdivo-sales-60-percent-earnings-32-percent-eps-guidance?app=1&uprof=46#email_link
BMY
Bristol-Myers Squibb Reports First Quarter Financial Results
Date : 04/27/2017 @ 6:59AM
Source : Business Wire
Bristol Myers Sqibb (NYSE:BMY)
Increases First Quarter Revenues 12% to $4.9 Billion
Posts First Quarter GAAP EPS of $0.94 and Non-GAAP EPS of $0.84
Achieves Key Regulatory Milestones For Opdivo in the U.S. and Europe
Advances Immuno-Oncology Collaborations with Incyte and Exelixis to include Phase 3 Trials
Increases 2017 GAAP and Non-GAAP EPS Guidance
Bristol-Myers Squibb Company (NYSE:BMY) today reported results for the first quarter of 2017, which were highlighted by strong sales for key products Opdivo and Eliquis, regulatory approval for Opdivo in advanced bladder cancer in the U.S., positive opinions from the Committee for Medicinal Products for Human Use (CHMP) for advanced bladder and head and neck cancers in Europe, and strategic transactions in oncology that further strengthened the company’s pipeline.
“During the first quarter we delivered strong sales and earnings growth, achieved important regulatory milestones for Opdivo in the U.S. and Europe and presented important new data across our Immuno-Oncology and fibrosis portfolios,” said Giovanni Caforio, M.D., chief executive officer, Bristol-Myers Squibb. “Building on this strong start to the year, we will continue to drive commercial performance in the short-term while advancing important opportunities to broaden our approach in Immuno-Oncology and progressing our early specialty portfolio.”
First Quarter
$ amounts in millions, except per share amounts
2017 2016 Change
Total Revenues $4,929 $4,391 12%
GAAP Diluted EPS 0.94 0.71 32%
Non-GAAP Diluted EPS 0.84 0.74 14%
FIRST QUARTER FINANCIAL RESULTS
Bristol-Myers Squibb posted first quarter 2017 revenues of $4.9 billion, an increase of 12% compared to the same period a year ago. Revenues increased 13% when adjusted for foreign exchange impact.
U.S. revenues increased 8% to $2.7 billion in the quarter compared to the same period a year ago. International revenues increased 18%. When adjusted for foreign exchange impact, international revenues increased 20%.
Gross margin as a percentage of revenue decreased from 76.0% to 74.5% in the quarter primarily due to product mix.
Marketing, selling and administrative expenses increased 1% to $1.1 billion in the quarter.
Research and development expenses increased 13% to $1.3 billion in the quarter.
The effective tax rate was 21.9% in the quarter, compared to 27.1% in the first quarter last year.
The company reported net earnings attributable to Bristol-Myers Squibb of $1.6 billion, or $0.94 per share, in the first quarter compared to net earnings of $1.2 billion, or $0.71 per share, for the same period in 2016. The results for the first quarter of 2017 included Bristol-Myers Squibb’s share of a patent-infringement litigation settlement related to Merck’s PD-1 antibody Keytruda® that contributed $0.18 per share.
The company reported non-GAAP net earnings attributable to Bristol-Myers Squibb of $1.4 billion, or $0.84 per share, in the first quarter, compared to $1.2 billion, or $0.74 per share, for the same period in 2016. An overview of specified items is discussed under the “Use of Non-GAAP Financial Information” section.
Cash, cash equivalents and marketable securities were $8.8 billion, with a net cash position of $360 million, as of March 31, 2017.
FIRST QUARTER PRODUCT AND PIPELINE UPDATE
Product Sales/Business Highlights
The increase in global revenues for the first quarter of 2017, compared to the first quarter of 2016, was driven by:
Product Growth %
Opdivo 60%
Eliquis 50%
Yervoy 25%
Sprycel 14%
Orencia 13%
Regulatory
In April, the company announced the CHMP recommended the approval of Opdivo for the treatment of patients with locally advanced unresectable or metastatic urothelial carcinoma (mUC) in adults after failure of prior platinum-containing chemotherapy. The CHMP recommendation will be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).
In April, the company announced the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application seeking to extend the use of Opdivo to patients with mismatch repair deficient or microsatellite instability high metastatic colorectal cancer after prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. The FDA granted the application priority review and the FDA action date is August 2, 2017.
In April, the FDA approved an updated indication for Opdivo for the treatment of adult patients with Classical Hodgkin lymphoma that have relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or three or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
In March, the company announced the CHMP recommended the approval of Opdivo as monotherapy for the treatment of squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy. The CHMP recommendation will be reviewed by the EC.
In March, the company and its partner Ono Pharmaceutical Co. announced the approval of Opdivo as monotherapy for the treatment of recurrent or metastatic head and neck cancer in Japan.
In February, the company announced the FDA provided accelerated approval for Opdivo for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Clinical
In April, at the American Association for Cancer Research (AACR) Annual Meeting, the company announced new data and analysis from studies evaluating Opdivo and the Opdivo + Yervoy regimen:
First overall survival results from CheckMate -067, a Phase 3 trial of Opdivo and the Opdivo + Yervoy regimen versus Yervoy alone in patients with previously untreated advanced melanoma. More detail of the study results is included in the original press release (link).
The first report of five-year overall survival data from the Phase 1 dose-ranging study CA209-003 evaluating Opdivo in patients with previously treated advanced non-small cell lung cancer. More detail of the study results is included in the original press release (link).
In April, the company announced CheckMate -143, a randomized Phase 3 clinical trial evaluating the efficacy and safety of Opdivo in patients with first recurrence of glioblastoma multiforme did not meet its primary endpoint of improved overall survival over bevacizumab monotherapy.
Sprycel
In February, the company announced the European Patent Office (EPO) upheld a decision finding European Patent No. 1169038 (the '038 patent), the Composition of Matter patent covering dasatinib, the active ingredient in Sprycel, to be invalid. The decision does not impact patents outside of the EU or other Sprycel-related patents. Additionally in February, the EPO Board of Appeal reversed and remanded an invalidity decision on European Patent No. 1610780 and its claim to the use of dasatinib to treat chronic myeloid leukemia (CML), which the EPO's Opposition Division had revoked in October 2012. The company intends to take appropriate legal actions to protect Sprycel.
Eliquis
In March, at the American College of Cardiology’s (ACC) Annual Scientific Session, the company and its partner Pfizer Inc. announced findings from a real-world data analysis of the U.S. Medicare database comparing the risk of stroke or systemic embolism and rate of major bleeding among patients with non-valvular atrial fibrillation who were treated with direct oral anticoagulants Eliquis, dabigatran or rivaroxaban versus warfarin. More detail of the analysis is included in the original press release (link).
Fibrosis
In April, at EASL: The International Liver Congress, the company announced data from a Phase 2 study of BMS-986036, an investigational pegylated analogue of human fibroblast growth factor 21 (FGF21), a key regulator of metabolism, in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH ) (F1-F3). The study achieved its primary endpoint of significant reduction in liver fat versus placebo, and also showed improvement in markers of liver injury and fibrosis.
FIRST QUARTER BUSINESS DEVELOPMENT UPDATE
In April, the company and Transgene announced a clinical research collaboration to evaluate the safety, tolerability and efficacy of Transgene’s investigational therapeutic vaccine TG4010 in combination with Opdivo + standard chemotherapy (CT) as a first-line treatment for advanced non-squamous non-small cell lung cancer (NSCLC) in patients whose tumors have low or undetectable levels of PD-L1.
In April, the company and Apexigen, Inc. announced a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of Apexigen’s APX005M with Opdivo in patients with second-line metastatic NSCLC who have failed prior chemotherapy, and in metastatic melanoma patients who have failed prior Immuno-Oncology (I-O) therapy.
In April, the company and Nordic Bioscience announced a collaboration to develop biomarker technology to potentially aid in the diagnosis and monitoring of fibrotic diseases including NASH.
In April, the company announced it entered into two separate agreements to outlicense BMS-986168, an anti-eTau compound in development for Progressive Supranuclear Palsy, to Biogen, and BMS-986089, an anti-myostatin adnectin in development for Duchenne Muscular Dystrophy, to Roche. The company will receive upfront payments of $300 million from Biogen and $170 million from Roche, along with potential milestone payments and royalties from each company.
In April, the company and Incyte Corporation announced an agreement to advance their clinical development program evaluating the combination of epacadostat, Incyte’s investigational oral selective IDO1 enzyme inhibitor, with Opdivo into Phase 3 registrational studies in first-line NSCLC across the spectrum of PD-L1 expression and first-line head and neck cancer. Additionally, the companies are expanding the ECHO-204 Phase 1/2 study, established under a collaboration between the companies in 2014, to include anti-PD-1/PD-L1 relapsed/refractory melanoma cohorts.
In March, the company and Foundation Medicine announced a collaboration to leverage Foundation Medicine’s comprehensive genomic profiling and molecular information solutions to identify predictive biomarkers such as Tumor Mutational Burden and Microsatellite Instability in patients enrolled across clinical trials investigating Bristol-Myers Squibb’s cancer immunotherapies.
In March, the company, the Parker Institute for Cancer Immunotherapy and the Cancer Research Institute (CRI) announced a multi-year collaboration agreement to coordinate and rapidly initiate clinical I-O studies across the Parker Institute and CRI networks.
In March, the company and CytomX Therapeutics, Inc. announced an expansion of their collaboration to discover novel therapies against multiple I-O targets using CytomX’s proprietary Probody® Platform, expanding the number of targets from four to twelve.
In March, the company announced an equity investment and plans for a research collaboration with GRAIL Inc. that grants the company early access to GRAIL’s comprehensive clinical trial databases that may help improve understanding of tumor genomics. Additionally, Bristol-Myers Squibb will utilize GRAIL’s analytics tools to inform research, advance diagnostics and improve patient outcomes.
In February, the company and Exelixis, Inc. announced a clinical development collaboration to evaluate Cabometyx® (cabozantinib), Exelixis’ small molecule inhibitor of receptor tyrosine kinases, with Opdivo, either alone or in combination with Yervoy. The agreement is expected to include a Phase 3 pivotal trial in first-line renal cell carcinoma, with additional trials planned in bladder cancer, hepatocellular carcinoma (HCC), and potentially other tumor types.
In February, the company announced an expansion of the five-year old International Immuno-Oncology Network (II-ON) with the addition of Columbia University Medical Center and Peter MacCallum Cancer Centre (Peter Mac). II-ON is a global peer-to-peer collaboration between Bristol-Myers Squibb and academia that aims to advance I-O science and translational medicine to improve patient outcomes.
SHARE REPURCHASE
In February, the company executed accelerated share repurchase (ASR) agreements to repurchase, in aggregate, $2 billion of the company’s common stock. The ASR was funded through a combination of debt and cash and is part of the company’s existing share repurchase authorization. Approximately 80 percent of the shares to be repurchased under the transaction were received by the company on February 28, 2017 and the company anticipates that all repurchases under the ASR will be completed by the end of the second quarter of 2017.
The decision reflects the company’s strong financial position and its balanced approach to capital allocation, including a commitment to its dividend and a disciplined approach to business development.
2017 FINANCIAL GUIDANCE
Bristol-Myers Squibb is increasing its 2017 GAAP EPS guidance range from $2.47- $2.67 to $2.72 - $2.87 and is increasing its non-GAAP EPS guidance range from $2.70 - $2.90 to $2.85 - $3.00. Both GAAP and non-GAAP guidance assume current exchange rates. Key revised 2017 GAAP and non-GAAP line-item guidance assumptions are:
Worldwide revenues increasing in the mid-single digits.
Research and development expenses increasing in the high-teens digit range for GAAP and increasing in the low-double digits range for non-GAAP.
An effective tax rate of approximately 22% for GAAP with non-GAAP remaining at approximately 21%.
The financial guidance excludes the impact of any potential future strategic acquisitions and divestitures and any specified items that have not yet been identified and quantified. The non-GAAP guidance also excludes other specified items as discussed under “Use of Non-GAAP Financial Information.” Details reconciling GAAP amounts to non-GAAP amounts, with non-GAAP reflecting specified items are provided in supplemental materials attached to this press release and available on the company’s website.
Keytruda® is a trademark of Merck & Co., Inc.
Probody® Platform is a trademark of CytomX Therapeutics, Inc.
Cabometyx® is a trademark of Exelixis, Inc.
Use of Non-GAAP Financial Information
This press release contains non-GAAP financial measures, including non-GAAP earnings and related EPS information, that are adjusted to exclude certain costs, expenses, gains and losses and other specified items that are evaluated on an individual basis. These items are adjusted after considering their quantitative and qualitative aspects and typically have one or more of the following characteristics, such as being highly variable, difficult to project, unusual in nature, significant to the results of a particular period or not indicative of future operating results. Similar charges or gains were recognized in prior periods and will likely reoccur in future periods including restructuring costs, accelerated depreciation and impairment of property, plant and equipment and intangible assets, R&D charges in connection with the acquisition or licensing of third party intellectual property rights, divestiture gains or losses, upfront payments from out licensed assets, pension charges, legal and other contractual settlements and debt redemption gains or losses, among other items. Deferred and current income taxes attributed to these items are also adjusted for considering their individual impact to the overall tax expense, deductibility and jurisdictional tax rates. Non-GAAP information is intended to portray the results of our baseline performance, supplement or enhance management, analysts and investors overall understanding of our underlying financial performance and facilitate comparisons among current, past and future periods. For example, non-GAAP earnings and EPS information is an indication of our baseline performance before items that are considered by us to not be reflective of our ongoing results. In addition, this information is among the primary indicators we use as a basis for evaluating performance, allocating resources, setting incentive compensation targets and planning and forecasting for future periods. This information is not intended to be considered in isolation or as a substitute for net earnings or diluted EPS prepared in accordance with GAAP.
Statement on Cautionary Factors
This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans and projections regarding the company’s financial position, results of operations, market position, product development and business strategy. These statements may be identified by the fact that they use words such as "anticipate", "estimates", "should", "expect", "guidance", "project", "intend", "plan", "believe" and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. These factors include, among other things, effects of the continuing implementation of governmental laws and regulations related to Medicare, Medicaid, Medicaid managed care organizations and entities under the Public Health Service 340B program, pharmaceutical rebates and reimbursement, market factors, competitive product development and approvals, pricing controls and pressures (including changes in rules and practices of managed care groups and institutional and governmental purchasers), economic conditions such as interest rate and currency exchange rate fluctuations, judicial decisions, claims and concerns that may arise regarding the safety and efficacy of in-line products and product candidates, changes to wholesaler inventory levels, variability in data provided by third parties, changes in, and interpretation of, governmental regulations and legislation affecting domestic or foreign operations, including tax obligations, changes to business or tax planning strategies, difficulties and delays in product development, manufacturing or sales including any potential future recalls, patent positions and the ultimate outcome of any litigation matter. These factors also include the company’s ability to execute successfully its strategic plans, including its business development strategy, the expiration of patents or data protection on certain products, including assumptions about the company’s ability to retain patent exclusivity of certain products, and the impact and result of governmental investigations. There can be no guarantees with respect to pipeline products that future clinical studies will support the data described in this release, that the compounds will receive necessary regulatory approvals, or that they will prove to be commercially successful; nor are there guarantees that regulatory approvals will be sought, or sought within currently expected timeframes, or that contractual milestones will be achieved. For further details and a discussion of these and other risks and uncertainties, see the company's periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Company and Conference Call Information
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.
There will be a conference call on April 27, 2017 at 10:30 a.m. EDT during which company executives will review financial information and address inquiries from investors and analysts. Investors and the general public are invited to listen to a live webcast of the call at http://investor.bms.com or by calling the U.S. toll free 855-303-0072 or international 913-312-0976, confirmation code: 500711. Materials related to the call will be available at the same website prior to the conference call. A replay of the call will be available beginning at 1:30 p.m. EDT on April 27, 2017 through 1:30 p.m. EDT on May 11, 2017. The replay will also be available through http://investor.bms.com or by calling the U.S. toll free 888-203-1112 or international 719-457-0820, confirmation code: 6160500.
BRISTOL-MYERS SQUIBB COMPANY
PRODUCT REVENUE
FOR THE THREE MONTHS ENDED MARCH 31, 2017 AND 2016
(Unaudited, dollars in millions)
(THE REMAINDER OMITTED)
Sold @ $10.90 after the tax proposal presentation. The market may go up, but the initial response wasn't very enthusiastic.
Back to bid sitting for Libbey.
LBY
Don't have PM, but see the analysts were correct for once:
Consensus Ratings for Seagate Technology PLC (NASDAQ:STX)
Ratings Breakdown: 1 Sell Rating, 18 Hold Ratings, 7 Buy Ratings, 1 Strong Buy Rating
Consensus Rating: Hold (Score: 2.30)
Consensus Price Target: $42.02 (16.81% downside)
https://www.marketbeat.com/stocks/NASDAQ/STX/
Both volume and volatility decreasing:
http://www.nasdaq.com/symbol/lby/historical
Chart improving with many positive technical cross-overs occurring or about to occur.
Looking less likely an easy flip and more a slow move up (although I have an ask in):
For me the troubling thing with STX is that it was up so much for the year.
LBY
Last trade on 4/24/17:
18:26:51 $ 53.6351 1,029,840 (shares)
http://www.nasdaq.com/symbol/bmy/after-hours
BMY
Still here. Added a few more shares on Thursday. Trying to trade like you are doing since it seems to trading in a pretty small range. Trying to sell at open because that is its typical high and buy back as it predictably goes down. A couple of days last week missed the early jump by a few pennies each day and this morning a bit more as I had the ask at $11.15.
Yeah disappointing that given the overall market it didn't stay above $11, but I guess it is the function of the large institutional holdings who are more long term.
Would love to figure it out better so could gain a few hundred each day. Not looking for homeruns.
LBY
Thanks for the info. Good news and seems to have perked up the pps while the overall IBB/LABU remain down.
What is your take on the ASCO presentations? Any critical or of great significance?
BMY
EMA hands down a number of recommendations
Apr. 21, 2017 1:37 PM ET|By: Stephen Alpher, SA News Editor
Source
Bristol-Myers' (NYSE:BMY) Opdivo (nivolumab) receives use extension recommendation.
__________________________________________
https://seekingalpha.com/news/3258752-ema-hands-number-recommendations?app=1&uprof=46#email_link
BMY
Eiger Announces Additional Phase 2 Clinical Trial Results for Lonafarnib at The International Liver Congress™ 2017
By PR Newswire, April 21, 2017, 08:00:00 AM EDT
PALO ALTO, Calif., April 21, 2017 /PRNewswire/ --
Eiger BioPharmaceuticals, Inc., (NASDAQ:EIGR) today announced additional supportive and encouraging lonafarnib (LNF) data from the LOWR HDV (LOnafarnib With Ritonavir in Hepatitis Delta Virus) Program presented at The International Liver Congress™ 2017, in Amsterdam, Netherlands. After 24 weeks of treatment, all-oral lonafarnib-based regimens (LNF 25 mg or 50 mg BID + Ritonavir, or RTV) suppressed HDV-RNA below the limit of quantitation in 36% of patients, and 60% achieved ALT normalization. The addition of PEG IFN to LNF 25 mg BID + RTV (triple therapy) suppressed HDV-RNA below the limit of quantitation in 80% of patients, and 78% achieved ALT normalization. In patients treated for 48 weeks with triple therapy of PEG IFN + LNF 25 mg BID + RTV, PCR-negativity was achieved in 67% of patients at the end of treatment.
"The LOWR HDV program was designed to identify optimal lonafarnib-based regimens to advance in development for the treatment of HDV, and we're continuing to successfully progress towards our goal," said David Cory, President and CEO of Eiger. "Data presented this week demonstrate multiple encouraging outcomes with lonafarnib-based regimens including viral load decline greater than 2 logs, viral load below the limit of quantitation, PCR-negativity, and ALT normalization. In addition, the finding that anti-HDV activity is enhanced with the addition of pegylated interferon alpha to lonafarnib-based regimens is particularly encouraging. We plan to advance all-oral lonafarnib-based regimens as well as triple therapy to include pegylated interferon lambda as potential treatments for HDV."
Key Results from LOWR Program Presentations:
End of Treatment Results at Week 24 (24 weeks dosing)
All-Oral LNF 25 mg or 50 mg BID + RTV suppresses HDV-RNA at end of treatment (Week 24)
5 of 14 (36%) HDV-RNA < LOQ (Limit of Quantitation by qPCR)
1 of 14 (9%) PCR-negative
4 of 8 (50%) > 2 log decline in patients with high baseline viral load (HDV RNA > 5 log)
Addition of PEG IFN to LNF 25 mg BID + RTV results in the highest response rates (Week 24)
4 of 5 (80%) HDV-RNA < LOQ
3 of 5 (60%) PCR-negative
3 of 4 (75%) > 2 log decline in patients with high baseline viral load (HDV RNA > 5 log)
ALT normalization achieved in LNF 25 mg or 50 mg BID + RTV regimens
60% (all-oral)
78% (with PEG IFN)
Adverse events (AEs) predominantly mild / moderate GI events with LNF treatment
Post-Treatment Follow-Up at Week 48 (24 weeks dosing + 24 weeks post-dosing)
Addition of PEG IFN to LNF 25 mg BID + RTV led to low-level viremia off therapy, with PCR negativity in patients at 24 weeks post-treatment
2 of 2 PCR-negative at 24 weeks post-treatment
End of Treatment Results at Week 48 (48 weeks dosing)
Addition of PEG IFN to LNF 25 mg BID + RTV
2 of 3 (67%) PCR-negative
Additional dosing regimens were also explored in the LOWR program, including QD dosing of LNF + RTV and dose titration with BID dosing of LNF + RTV. Anti-HDV activity was observed in all regimens (LNF 50 mg QD + RTV up to LNF 100 mg BID + RTV) through Week 24 on treatment. HDV viral load returned to baseline in a majority of these patients by Week 24 of post-treatment, suggesting longer-term treatment of all-oral LNF + RTV or triple combination of LNF + RTV + PEG IFN may be necessary to achieve sustained antiviral suppression.
"Hepatitis Delta is the most aggressive form of viral hepatitis, and due to the absence of an approved therapy, HDV infection remains a significant unmet medical need and a public health challenge," said Eduardo Martins, MD, DPhil, Senior Vice President of Liver and Infectious Diseases Development at Eiger. "Each of the lonafarnib presentations given at The International Liver Congress™ 2017 highlight the activity of lonafarnib-based regimens in the treatment of patients with HDV infection. We look forward to discussing next steps with regulatory agencies later this year."
Presentations at The International Liver Congress™ 2017:
Wedemeyer, H. et al; "A Phase 2 Dose-Escalation Study of Lonafarnib Plus Ritonavir in Patients With Chronic Hepatitis D: Final Results from The Lonafarnib With Ritonavir in HDV-4 (LOWR HDV-4) Study"; Abstract #PS-039, Oral Presentation.
Yurdaydin, C. et al; "A Phase 2 Dose-Optimization Study of Lonafarnib with Ritonavir for the Treatment of Chronic Delta Hepatitis—End of Treatment Results from the LOWR HDV-2 Study"; Abstract #GS-008, Oral Presentation.
Koh, C. et al; "Phase 2 study exploring once daily dosing of ritonavir boosted lonafarnib for the treatment of chronic delta hepatitis - end of study results from the LOWR HDV-3 study"; Abstract #LBP-519, Poster Presentation.
Yurdaydin, C. et al; "The Prenylation Inhibitor Lonafarnib (LNF) Can Induce Post-Treatment Viral Clearance in Patients with Chronic Delta Hepatitis (CDH) Resulting in ALT Normalization and Regression of Fibrosis"; Abstract #THU-161, Poster Presentation, Oral ePoster Presentation.
Yurdaydin, C. et al; "Results from Retreatment with Lonafarnib of a Subset of HDV-Infected Patients"; 13th Hepatitis Delta International Network (HDIN) Meeting, Oral Presentation.
LOWR HDV Studies:
The LOWR HDV program was designed to be a multi-center, international Phase 2 program, to identify dosing regimens and durations of lonafarnib (LNF) with ritonavir (RTV) ± pegylated interferon (PEG IFN) to move forward in development for the treatment of hepatitis delta infection (HDV).
LOWR HDV - 2 is a dose-finding study to identify combination regimens of lonafarnib and ritonavir ± PEG IFN a, with efficacy and tolerability for longer term dosing to enable HDV RNA clearance. In this open-label study, 58 HDV-infected patients have been enrolled to date into 10 groups of different doses of lonafarnib in combination with ritonavir ± PEG IFN a for dosing durations of 12 to 48 weeks. Lonafarnib doses range from 25 mg BID to 100 mg BID. LOWR HDV - 2 is closing at Ankara University in Ankara, Turkey.
LOWR HDV - 3 was a double-blinded, randomized, placebo-controlled study designed to evaluate the efficacy and tolerability of once-daily doses of lonafarnib - 50 mg, 75 mg and 100 mg - each combined with ritonavir 100 mg once daily for 12 or 24 weeks. Twenty-one patients with chronic hepatitis delta were randomized into one of six treatment groups. LOWR HDV - 3 was conducted at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland, and the study has completed.
LOWR HDV - 4 was an open-label study to evaluate the efficacy and tolerability of dose escalation of lonafarnib combined with ritonavir administered twice daily for dosing durations of 24 weeks. Fifteen patients were initiated at lonafarnib 50 mg and ritonavir 100 mg twice daily, and dose-escalated up to lonafarnib 100 mg twice daily as tolerated. LOWR HDV - 4 was conducted at Hannover Medical School in Hannover, Germany, and the study has completed.
About Sarasar™ (lonafarnib)
Lonafarnib is a well-characterized, late-stage, orally active inhibitor of farnesyl transferase, an enzyme involved in modification of proteins through a process called prenylation. HDV uses this host cell process inside liver cells to complete a key step in its life cycle. Lonafarnib inhibits the prenylation step of HDV replication inside liver cells and blocks the virus life cycle at the stage of assembly. Lonafarnib has been dosed in over 120 HDV-infected patients across international academic centers and is in Phase 2 development for HDV. Lonafarnib has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), and Fast Track Designation by U.S. FDA. Lonafarnib is not approved for any indication, and is licensed from Merck Sharp & Dohme Corp. (known as MSD outside of the United States and Canada).
About Hepatitis Delta Virus (HDV)
Hepatitis Delta (or Hepatitis D) is caused by infection with HDV and is considered to be one of the most severe forms of viral hepatitis in humans. Hepatitis delta occurs only as a co-infection in individuals harboring Hepatitis B Virus (HBV). Hepatitis delta leads to more severe liver disease than HBV alone and is associated with accelerated liver fibrosis, liver cancer, and liver failure. Hepatitis delta is a disease with a significant impact on global health, which may affect up to approximately 15-20 million people worldwide. The prevalence of HDV varies among different parts of the world. Globally, HDV infection is reported to be present in approximately 4.3% to 5.7% of chronic Hepatitis B carriers. The prevalence of HDV in patients infected with chronic HBV is even higher in certain regions, including certain parts of Mongolia, China, Russia, Central Asia, Pakistan, Turkey, Africa, and South America, with an HDV prevalence as high as 60% being reported in HBV-infected patients in Mongolia and Pakistan.
About Eiger
Eiger is a clinical-stage biopharmaceutical company committed to bringing to market novel products for the treatment of rare diseases. The company has built a diverse portfolio of well-characterized product candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which an effective therapy is urgently needed.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives, intentions, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "project," "target," "will" and other words and terms of similar meaning. Examples of such statements include, but are not limited to, whether or not pegylated interferon lambda-1a or lonafarnib or ubenimex or exendin 9-39 may be further developed and approved, and whether promising earlier clinical study results will be repeated in larger, later clinical studies, statements relating to the availability of cash for Eiger's future operations, Eiger's ability to develop its drug candidates for potential commercialization, the timing of the commencement and number and completion of Phase 2 trials and whether the products can be successfully developed or commercialized. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Eiger makes, including the risks described in the "Risk Factors" sections in the Annual Report on Form 10-K for the period ended December 31, 2016 and Eiger's periodic reports filed with the SEC. Eiger does not assume any obligation to update any forward-looking statements, except as required by law.
Investors: Ingrid Choong, PhD, Eiger BioPharmaceuticals, 650-619-6115, ichoong@eigerbio.com
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/eiger-announces-additional-phase-2-clinical-trial-results-for-lonafarnib-at-the-international-liver-congress-2017-300443308.html
SOURCE Eiger BioPharmaceuticals, Inc.
_____________________________________________
EIGR
I bought back in @ $10.60 but didn't post as thought would be out shortly. I set a $11.05 ask target but it only reached $11.02 so still in.
It held well throughout the day, but the last few minutes were brutal. Didn't think the last minute sell-off would be that bad with the high institutional holdings.
You are correct. Hadn't looked back that far:
Hard to find a rational technical support level and there are so few analysts on the company, but can't believe it will go much lower unless the whole market goes way down. You agree?
BMY
The 4 Best Dividend Stocks in Pharmaceuticals
Cory Renauer (TMFang4apples) Apr 18, 2017 at 11:04AM
If you're looking for steadily growing income, the pharmaceutical industry boasts plenty of dividend-paying stocks. Not all of them are created equal, though, and plenty of investors in this space have seen their payouts frozen or slashed in recent years as their leading products succumbed to generic competition.
Luckily, Bristol-Myers Squibb Co. (NYSE:BMY), Eli Lilly and Co. (NYSE:LLY), Johnson & Johnson (NYSE:JNJ), and Pfizer Inc. (NYSE:PFE) possess the right combination of outperforming products and potential growth drivers to continue to raise their distributions for many years to come. Come see for yourself why these are the best dividend stocks in big pharma you can buy now.
Bristol-Myers Squibb Co.: In the bargain bin
At recent prices, shares of this pharmaceutical company offer investors a nice 2.8% yield that they can reasonably expect will keep rising for years to come. Over the past year, the company used about 57% of profits to make payments, and the company's bottom line is climbing on the back of Opdivo, a promising cancer therapy that helps patients' immune systems attack their tumors.
In recent months, Bristol-Myers Squibb stock has fallen to bargain-bin prices, largely because Opdivo failed to outperform standard chemo in a trial with newly diagnosed lung cancer patients. Although Opdivo appears unlikely to become a first-line treatment option for this large patient population, it's important to view the setback in light of the drug's impressive track record. Since earning its first approval at the end of 2014, the drug is now approved for 11 indications across six tumor types and generated sales of $3.8 billion in 2016.
Bristol-Myers Squibb's oncology success isn't limited to Opdivo. Orencia and Sprycel both grew annual sales by double-digit percentages last year and contributed $2.3 billion and $1.8 billion, respectively, to the company's top line. Beyond oncology, the company's next-generation blood thinner Eliquis, which is marketed in partnership with Pfizer, continues to exceed expectations. Last year, sales of the anticoagulant jumped 80% to $3.3 billion.
Bristol's stable of growth drivers could push up total profits at a blazing pace for a big pharmaceutical company. The average analyst following the company expects earnings to increase at an 11.8% annual growth rate over the next five years. The company is poised to continue to grow, with 10 new immuno-oncology candidates in clinical trials across 35 tumor types.
_________________________________________________
https://www.fool.com/investing/2017/04/18/is-abbvie-a-great-dividend-stock-for-your-portfoli.aspx
BMY
Eiger Announces Industry Veteran Lisa Porter, M.D. to Lead Development of Exendin 9-39 for the Treatment of Post-Bariatric Hypoglycemia
By PR Newswire, April 18, 2017, 08:00:00 AM EDT
- Novel Liquid Formulation of Exendin 9-39 Advancing
PALO ALTO, Calif., April 18, 2017 /PRNewswire/ --
Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of therapies for rare diseases, today announced the appointment of Lisa Porter, M.D. to lead the development of exendin 9-39 for the treatment of post-bariatric hypoglycemia (PBH).
"Dr. Porter brings over 15 years of experience in developing medicines for diabetes and metabolic diseases with a singular focus on bringing innovative therapies to patients with high unmet need," said David Cory, President and CEO of Eiger. "As the exendin 9-39 program in PBH matures with nearly 30 patients dosed in the clinic, we prepare to advance a novel liquid formulation of exendin 9-39 and are very excited to welcome Dr. Porter to the team. We have great confidence that she will take exendin 9-39 and the PBH program to the next level."
Dr. Porter was most recently Chief Medical Officer of Dance BioPharm, focused on the development of inhaled insulin products to treat diabetes. Previously, she was Vice President, Medical Development of Amylin Pharmaceuticals where she led the R&D efforts for the Amylin-Lilly Alliance culminating in the approval of the GLP-1 agonist Bydureon (exenatide extended release), the first once weekly treatment for Type 2 diabetes. Earlier, Dr. Porter held positions of increasing leadership at GlaxoSmithKline, where she was responsible for clinical strategy for Avandia (rosiglitazone) for Type 2 diabetes. Dr. Porter earned a B.S. in Biology from William & Mary, an M.D. from Duke University, and completed her fellowship in Endocrinology and Hypertension at Brigham and Women's Hospital.
"Eiger and Stanford have made amazing progress across multiple clinical studies in which exendin 9-39 was shown to prevent and reduce symptoms of hypoglycemia in post-bariatric surgical patients during an oral glucose tolerance test (OGTT), and I'm very encouraged by the results," said Lisa Porter, M.D. "Exendin 9-39 represents the first potential targeted therapy for patients suffering from PBH, a significant unmet medical need. I'm excited to join the team and lead this program moving forward."
Eiger is developing a proprietary, novel liquid formulation of exendin 9-39 which in dog studies has demonstrated a greater than two-fold increase in peak plasma concentrations compared to the original lyophilized powder of exendin 9-39. Development of a liquid formulation of exendin 9-39 represents an opportunity for lower dosing and once on the market, would eliminate the need for patients to dissolve powder in saline, which could be a more convenient product presentation for patients. Eiger is evaluating the new exendin 9-39 liquid formulation in patients in the ongoing MAD study and also in a Phase 1 PK study scheduled for Q2 2017, both of which will inform the next, larger Phase 2 study planned for second half 2017.
About Insulin, GLP-1, and Exendin 9-39
Insulin is the principal physiologic hormone secreted to control high blood glucose levels. Abnormal increases in insulin secretion can lead to profound hypoglycemia (low blood sugar), a state that can result in significant morbidities, including seizures, brain damage, and coma. GLP-1 is a gastrointestinal hormone that is released postprandially from the intestinal L-cells. GLP-1 binds to GLP-1 receptors on the beta cells of the pancreas and increases the release of insulin. In patients with PBH,
GLP-1-mediated insulin secretion is dysfunctionally exaggerated.
Exendin 9-39 is a 31-amino acid peptide that selectively targets and blocks GLP-1 receptors, normalizing insulin secretion by the pancreas, and thereby reducing postprandial hypoglycemia. Exendin 9-39 is being investigated as a novel treatment for PBH. Exendin 9-39 has been granted orphan designation in the European Union by the EMA for the treatment of non-insulinoma pancreatogenous hypoglycemia syndrome (NIPHS) and orphan designation in the United States by the FDA for the treatment of hyperinsulinemic hypoglycemia. Both of these broad designations include PBH. A therapy that safely and effectively mitigates insulin-induced hypoglycemia has the potential to address a significant unmet therapeutic need for certain rare medical conditions associated with hyperinsulinism. Exendin 9-39 has never been approved or commercialized for any indication. The long-term efficacy and safety of subcutaneous (SC) injected exendin 9-39 have not yet been established. More information on exendin 9-39 clinical trials may be found at www.clinicaltrials.gov.
About Post-Bariatric Hypoglycemia (PBH)
Approximately 150,000-200,000 bariatric surgical procedures are performed each year in the United States, and another 100,000 are performed each year in Europe. The estimated prevalence of PBH is approximately 30,000 in the United States and approximately 25,000 in the European Union. As the number of bariatric surgeries to treat obesity and related comorbidities has increased, so too has the number of individuals who experience PBH, with symptoms typically developing 12 to 18 months following surgery. PBH can occur with a range of severity in post-bariatric surgery patients. Mild to moderate hypoglycemia may be managed largely through dietary carbohydrate restriction, whereas severe hypoglycemia results in neuroglycopenic outcomes (altered mental status, loss of consciousness, seizures, coma) which are unresponsive to diet modification. Severe PBH can be debilitating with a significant negative impact on quality of life. There is no approved pharmacologic therapy.
About Eiger
Eiger is a clinical-stage biopharmaceutical company committed to bringing to market novel products for the treatment of rare diseases. The company has built a diverse portfolio of well-characterized product candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is identified, and for which an effective therapy is urgently needed. For more information, please visit the Company's website at www.eigerbio.com.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives, intentions, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "project," "target," "will" and other words and terms of similar meaning. Examples of such statements include, but are not limited to, whether or not pegylated interferon lambda-1a, lonafarnib, ubenimex or exendin 9-39, including SC formulation, may be further developed and approved, whether Phase 1 and Phase 2 studies of exendin 9-39 will show safety and activity consistent with early clinical results, including the interim results of the MAD study, or that the new liquid formulation will be consistent with results seen with IV and SC formulations of exendin 9-39, statements relating to the availability of cash for Eiger's future operations, Eiger's ability to develop its drug candidates for potential commercialization, the timing of the commencement and number and completion of Phase 2 trials and whether the products can be successfully developed or commercialized. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Eiger makes, including the risks described in the "Risk Factors" sections in the Annual Report on Form 10-K for the period ended December 31, 2016 and our periodic reports filed with the Securities and Exchange Commission. Eiger assumes no obligation to update any forward-looking statements, except as required by law.
Investors: Ingrid Choong, PhD email: ichoong@eigerbio.com Phone: 1-650-619-6115
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/eiger-announces-industry-veteran-lisa-porter-md-to-lead-development-of-exendin-9-39-for-the-treatment-of-post-bariatric-hypoglycemia-300440724.html
SOURCE Eiger BioPharmaceuticals, Inc.
________________________________
EIGR
$heff did but he indicated so long after the fact so don't know when he sold. Presumably Dan Ward is still in according to Tweets.
I'm in. Been a real bust, but hopefully the abstracts aren't as bad as the market indicated. The analysts were supportive after they were released.
You holding till data presentation?
EIGR