Jun. 19, 2014, 9:43 AM
- Shareholders of Celgene (CELG) approve a 2:1 stock split and increase in the number of authorized shares. The split will increase the total number of shares of common stock from 399M to 798M while the number of authorized shares grows to 1,150M from 575M.
- Shareholders of record June 18, 2014 will be entitled to receive an additional share per share held. Distribution date is June 25.
- This is the company's fourth stock split. There was a 3:1 split on April 17, 2000, a 2:1 split on October 25, 2004 and a 2:1 split on February 27, 2006.
Jun. 14, 2014, 12:34 PM
- Switzerland-based Celgene (CELG) subsidiary Celgene Interantional Sarl announces the results from a Phase 3 clinical trial evaluating the safety and efficacy of Vidaza (azacitidine for injection) compared to conventional care regimens (CCR) in elderly patients with newly-diagnosed acute myeloid leukemia (AML).
- The primary endpoint was median overall survival (OS). The OS for the azacitidine group (n=241) was 10.4 months (8.0 - 12.7 months; 95% CI) compared to 6.5 months (5.0 - 8.6 months; 95% CI) in the CCR group (n=247). The results failed to achieve statistical significance.
- One-year survival was 47% in the azacitidine cohort compared to 34% of patients receiving CCR.
- The clinical trial was conducted to support a possible label expansion for Vidaza. It is currently indicated for treatment of patients with certain types of refractory anemia.
Jun. 3, 2014, 5:03 PM
- NanoString (NSTG -2.9%) and Celgene (CELG +0.4%) collaborate on the development of a companion diagnostic assay using NSTG's nCounter Analysis System to support the clinical validation of CELG's Revlimid for the treatment of Diffuse Large B-Cell Lymphoma (DLBCL). Under the terms of the agreement, CELG will pay NSTG an upfront payment of $5.75M and up to $17M in milestone payments. NSTG may also earn an additional $22.25M in commercial payments if assay revenues do not exceed pre-specified levels during the first three years after regulatory approval.
- The test will be used to screen patients who are being enrolled in a clinical trial for Revlimid for DLBCL. After CELG completes the study, NSTG will pursue regulatory approval of the test in key global markets. It also retains the right to develop and commercialize additional indications for the assay.
May. 27, 2014, 12:32 PM
- The U.S. District Court for the District of New Jersey releases its Markman Order regarding the patent suit between Celgene (CELG +1%) and Natco Pharma, Arrow International and Watson Labs. Celgene alleges that the generic competitors infringe on its Revlimid patents ('230, '554, '800, '219 and '598).
- A Markman hearing is a pretrial hearing that determines the interpretations of specific terms/key words in a patent.
- Unless you have an intimate understanding of the patents, it is unclear how much or little the judge's ruling favors Celgene.
May. 22, 2014, 6:57 AM
- Celgene (CELG) Hematology & Oncology chief Mark Alles promoted to COO.
- CFO Jacqualyn Fouse, Ph.D., promoted to President Hematology & Oncology.
- Inflammation & Immunology leader Scott Smith promoted to President I & I.
- Peter Kellogg hired as EVP, CFO. Mr. Kellogg joins the company from Merck, where he was EVP & CFO.
- Press release
May. 19, 2014, 8:25 AM
- The FDA has granted breakthrough designation to Elotuzumab, a treatment for multiple myeloma developed by Bristol-Myers Squibb (BMY) and AbbVie (ABBV).
- The drug is to be given with Celgene's (CELG) Revlimid and the steroid dexamethasone.
- In June, the companies said that Elotuzumab helped patients with previously-treated multiple myeloma live for a median 33 months without the blood cancer getting worse in a Phase II trial. (PR)
Apr. 25, 2014, 3:27 PM
- "It's Time ... We Think," is the title of a report from the team at Piper Jaffray, upgrading Celgene (CELG +1.1%) to Overweight.
- Noting significant cooling in biotech and even a massive beat from Gilead which barely moved the stock, Piper acknowledges it's a tough environment for high multiple names. But trading at 20x P/E with 20% sustainable EPS growth means Celgene is either going to soon be considered a value play or see multiple stabilization.
- "We believe the valuation now reflects a conservative 2024 Revlimid patent expiry and excludes meaningful contribution from the advancing pipeline ... [Celgene] is attuned to delivering shareholder value and we believe will fight aggressively to lift the Revlimid polymorph patent overhang and deliver sustainable EPS growth."
- Celgene's gain today comes as the biotech sector slips about 4%.
Apr. 24, 2014, 8:43 AM
- Celgene (CELG) has licensed a treatment codenamed GED-0301 for moderate-to-severe Crohns disease and other indications from Dublin-based Nogra Pharma.
- Celgene will pay $710M upfront, development and regulatory milestones of as much as $815M, and sales milestones of up to $1.05B.
- GED-0301 "demonstrated striking clinical activity in a phase II trial for Crohns disease," Celgene says, with the company planning to start a Phase III study by the year-end.
- Shares are -2.1%. (PR).
- Q1 earnings
Apr. 24, 2014, 8:04 AM
- Net product sales increased 19% yoy to $1.71B. Net income was $280M (-27.3%) or $0.66/share (-25.8%).
- Revlimid sales increased 14% to $1.14B. U.S. revenue was $642M (+13%) and International was $502M (+16%).
- Abraxane sales were $185M (+51%).
- Vidaza sales were $148M (-27%).
- Pomalyst/Imnovid sales were $136M.
- 10.7M shares were repurchased for a total cost of ~$1.7B. As of March 31 there was $407M remaining to be repurchased under the program. On April 17, the BOD authorized an additional $4B.
- CF Ops was $557M (+51.6%).
- Updated 2014 guidance includes total revenues of $7.5B, Revlimid sales of $4.9B - $5B, Abraxane sales of $850M - $900M and EPS of $4.94 - $5.18.
Apr. 24, 2014, 7:35 AM
Apr. 24, 2014, 12:05 AM
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Apr. 23, 2014, 5:30 PM
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Apr. 4, 2014, 4:20 PM
- The recent selloff in Nasdaq momentum names spilled over to the rest of the stock market today, pulling the Dow and S&P sharply lower from their record highs hit earlier in the session.
- The S&P 500's 1.2% drop was less than half the Nasdaq's 2.6% plunge, but its 1,865 close was well below the 1,875 some technicians saw as a resistance level.
- The selling that started in biotechs a few weeks ago has carried over into cloud and enterprise software names, Internet and other high-flying tech names.
- Looking around Nasdaq, the carnage is evident: ICPT -9.6%, FEYE -8.2%, YELP -6.8%, TRIP -6.1%, TSLA -5.8%, ILMN -5.8%, SPLK -5.5%,NFLX -4.9%, PCLN -4.8%, FB -4.6%, GOOG -4.6%, BIIB -4.5%, CELG -4.3%, WDAY -3.8%, AMZN -3.2%, GILD -2.4%, TWTR -2%.
- Recent high-fliers also are seeing a surge in volatility to go along with their declines; the implied volatility of the iShares Biotech Fund (IBB -4%) is near its highest level in at least two years.
- Treasurys rallied as the latest employment report eased concerns that the Fed could raise interest rates sooner than expected; the 10-year yield fell 6 bps at 2.732%.
Apr. 4, 2014, 7:18 AM
- Mylan (MYL) has sued Celgene (CELG) over the what Mylan says are illegal actions that Celgene has taken to keep generic versions of its Revlimid and Thalomid blockbuster drugs off the market.
- Mylan wants to force Celgene to sell it enough Revlimid and Thalomid at market prices so that it can carry out bioequivalence testing. Mylan also wants damages for its inability to sell generic versions of the therapies.
- Revlimid treats disorders caused by poorly formed blood cells and Thalomid is for Hansen's Disease, or leprosy.
Apr. 1, 2014, 9:57 AM
- Celgene (CELG +4.2%) has deepened its relationship with biotech Forma Therapeutics, signing a collaboration deal that will use the latter's screening technique to identify potential new drugs that Celgene could license.
- Celgene has paid $225M up front for 3 1/2 years of co-operation, after which the sides can participate in two more periods of collaboration of two years each. Celgene would pay a total of $375M in milestones and would also eventually have the option to acquire Forma.
- Forma will retain U.S. rights to any therapies developed in the deal.
- The agreement follows Celgene and Forma initially forging a partnership almost a year ago. (PR)
Mar. 26, 2014, 8:33 AM
- Large cap pharma and biotech firms have regenerative therapy R&D programs underway according to a recent survey.
- 69% of respondents are focused on developing cellular-based therapies.
- Wound healing and burns have the greatest near-term potential.
- Long term areas of interest are cardiovascular disease, oncology, neurodegenerative disease, monogenic disorders and ocular disease.
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