AbbVie Inc. (ABBV) - NYSE
  • Today, 7:42 AM
    • AbbVie (NYSE:ABBV): Q2 EPS of $1.26 beats by $0.06.
    • Revenue of $6.4B (+17.0% Y/Y) beats by $200M.
    • Shares +1.5% PM.
    • Press Release
    | Today, 7:42 AM | 9 Comments
  • Tue, Jul. 5, 5:38 PM
    • Top gainers, as of 5.25 p.m.: QUNR +18.1%. GRMN +13.6%. ABBV +4.0%. YY +3.2%. QRVO +2.1%.
    • Top losers, as of 5.25p.m.: IBN -15.8%. NUS -10.3%. GSK -3.3%. CIG -1.7%. KOPN -1.4%.
    | Tue, Jul. 5, 5:38 PM | 4 Comments
  • Fri, Jul. 1, 7:07 AM
    • Micro cap OraSure Technologies (NASDAQ:OSUR) fell 16% yesterday on more than 8x normal volume as informed investors ran for the exits before today's announcement that AbbVie (NYSE:ABBV) has backed out of its co-promotion agreement regarding OraSure's OraQuick HCV Rapid Antibody Test. The deal will now end on December 31 of this year instead of December 31, 2019.
    • OraSure was supposed to receive up to $75M in exclusivity payments from AbbVie over the term of the partnership. It has been ratably recognizing the payments since the deal was inked in June 2014 and will book $5.4M for the remainder of this year.
    • When the agreement ends, AbbVie will have no further obligations to co-promote the test or any other obligations to OraSure.
    • OraSure will host a conference call this morning at 8:30 am ET to discuss the situation. Shares are down 11% premarket this morning.
    • SA Contributor Richard Pearson nailed the call: Expect OraSure To Drop 35% (Or More) Next Week
    | Fri, Jul. 1, 7:07 AM | 4 Comments
  • Tue, Jun. 14, 7:54 AM
    • Micro cap Infinity Pharmaceuticals (NASDAQ:INFI) is down 67% premarket on increased volume in response to its announcement that will close down its discovery research organization and lay off 46 employees (21% of its workforce) prompted by less-than-expected results in a mid-stage study assessing lead product candidate duvelisib for the treatment of refractory indolent non-Hodgkin lymphoma (iNHL), a slow-growing blood cancer. In addition, the company and development partner AbbVie (NYSE:ABBV) have agreed to pause AbbVie's Phase 1b/2 trial evaluating the combination of duvelisib and venetoclax while Infinity evaluates its options with duvelisib.
    • The Phase 2 clinical trial, DYNAMO, assessed duvelisib as monotherapy in 129 patients with follicular lymphoma (n=83), small lymphocytic lymphoma (n=28) or marginal zone lymphoma (n=18) whose disease progressed or did not respond to treatment with Biogen's (NASDAQ:BIIB) Rituxan (rituximab) and either chemotherapy or radiotherapy. The primary endpoint was overall response rate (ORR).
    • Results showed an ORR of 46%, all partial responders and below expectations. The ORR in the three lymphoma types listed above were 41%, 68% and 33%, respectively. The data will be submitted to presentation at a future medical conference.
    • The most common serious adverse events (Grade 3 or higher) were neutropenia (low neutrophils) (28%), diarrhea (15%), thrombocytopenia (low blood platelets) (13%) and anemia (12%). 20% of participants experienced an infection of least Grade 3 (serious).
    • CEO Adelene Perkins says, "While DYNAMO met its primary endpoint, we hoped that treatment with duvelisib as monotherapy would have provided a larger clinical benefit....We plan to seek feedback from the FDA to determine our next steps with respect to duvelisib in iNHL."
    • Duvelisib is an investigational inhibitor of Class 1 phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma being jointly developed by Infinity and AbbVie. The PI3K pathway plays a key role in regulating the growth and survival of certain blood cancers. Inhibiting PI3K-delta and PI3K-gamma signaling blocks the growth and survival of tumor cells.
    • Infinity will release updated guidance after all these activities have been completed. Management will host a conference call at 8:30 am to discuss the situation.
    | Tue, Jun. 14, 7:54 AM
  • Tue, May 17, 10:56 AM
    • The U.S. Patent and Trademark Office's Patent Trial and Appeal Board has granted Coherus BioSciences' (CHRS +14.8%) request for an inter partes review of five patents covering AbbVie's (ABBV -3.7%) top seller Humira (adalimumab).
    • An inter partes review is a process whereby the patentability or validity of a patent is reviewed. The USPTO grants the hearing if the petitioner (challenger) has a reasonable chance of prevailing.
    • Coherus' pipeline includes Phase 3-stage CHS-1420, a biosimilar to AbbVie's blockbuster which booked almost $15B in sales over the past four quarters.
    • Update: In a press release, Coherus says the review is specific to U.S. Patent No. 8,889,135, covering the dosing regimen of 40 mg of Humira administered subcutaneously every 13 - 15 days to treat rheumatoid arthritis.
    | Tue, May 17, 10:56 AM | 18 Comments
  • Thu, Apr. 28, 3:56 PM
    • Thinly traded micro cap OncoMed Pharmaceuticals (OMED +16.4%) gets a nice bump from investors stoked by AbbVie's (ABBV +0.5%) $5.8B takeover of privately-held Stemcentrx, a developer of oncology therapies that target cancer stem cells. OncoMed does the same.
    • Its lead product candidate is Stage 2-phase demcizumab for the first-line treatment, in combination with carboplatin and pemetrexed, of non-squamous non-small cell lung cancer.
    | Thu, Apr. 28, 3:56 PM
  • Thu, Apr. 28, 8:46 AM
    • AbbVie (NYSE:ABBV) Q1 results ($M): Total Revenues: 5,958 (+18.2%); U.S.: 3,494 (+31.8%); Intl: 2,464 (+3.1%).
    • Net Income: 1,354 (+32.5%); Non-GAAP Net Income: 1,874 (+23.0%); EPS: 0.83 (+31.7%); Non-GAAP EPS: 1.15 (+22.3%).
    • Key Product Sales: Humira: 3,577 (+15.0%); V-Pak: 414; Imbruvica: 381; Synagis: 319 (-4.8%); Lupron: 190 (-1.0%).
    • 2016 Guidance: EPS: $3.87 - 4.07 from $4.45 - 4.65; Non-GAAP EPS: $4.62 - 4.82 from $4.90 - 5.10.
    • Shares are down 4% premarket on increased volume.
    | Thu, Apr. 28, 8:46 AM | 6 Comments
  • Thu, Apr. 28, 7:56 AM
    • AbbVie (NYSE:ABBV) acquires South San Francisco-based Stemcentrx for ~$5.8B in cash and stock. The deal includes ~$2.0B in cash and could include an additional $4B if regulatory and clinical milestones are achieved.
    • Stemcentrx, founded in 2008, develops cancer therapies that target cancer stem cells. It has five drug candidates in clinical development. Promising results have been observed in small cell lung cancer, triple-negative breast cancer, ovarian cancer and peritoneal cancer.
    • The deal will dilute earnings ~$0.20 this year. Accretion should begin in 2020. AbbVie's updated 2016 non-GAAP EPS is $4.62 - 4.82.
    • AbbVie will host a conference call this morning at 9:00 am ET to discuss the transaction.
    | Thu, Apr. 28, 7:56 AM | 13 Comments
  • Wed, Feb. 17, 8:55 AM
    • Micro cap Regulus Therapeutics (NASDAQ:RGLS) is up 43% premarket on robust volume in response to its announcement of positive interim results from a Phase 2 clinical trial assessing RG-101, in combination with other antivirals, in patients with chronic hepatitis C virus (HCV) infection.
    • The study was designed to evaluate a four-week treatment regimen of 2 mg/kg of RG-101 at Day 1 and Day 29, in addition to four weeks of once/daily Harvoni (ledipasvir/sofosbuvir), Olysio (simeprevir) or Daklinza (daclatasvir). Seventy-nine HCV-1 and HCV-4 patients are enrolled, while 38 have been evaluated through eight weeks of follow up. Of these, 97% (n=37/38) had HCV RNA viral loads below the limit of quantification (SVR12). For those assessed through 12 weeks of follow up, 100% (n=14/14) remained below the level of detection.
    • The primary endpoint analysis (12 week follow up) for all 79 subjects should be available in late Q2.
    • RG-101 is a microRNA therapeutic, specifically a GalNAc-conjugated anti-microRNA targeting microRNA-122. MicroRNAs are small bits of RNA, typically 20 - 25 nucleotides long, that do not encode proteins but regulate gene expression. Researchers believe as many as two-thirds of human genes are regulated by microRNAs.
    | Wed, Feb. 17, 8:55 AM | 65 Comments
  • Fri, Jan. 29, 8:27 AM
    • Gilead Sciences (NASDAQ:GILD) is feeling some of AbbVie's (NYSE:ABBV) pain in premarket trading. Shares are down 4% on robust volume while AbbVie slumps 3% on average volume.
    • AbbVie's Q4 U.S. sales of HCV med V-Pak were $197M, down almost 19% sequentially from Q3's $242M.
    | Fri, Jan. 29, 8:27 AM | 71 Comments
  • Thu, Jan. 14, 5:59 PM
    • Amgen's (AMGN +5.3%) efforts to make a biosimilar version of the top-selling prescription medicine get a setback as the U.S. patent office ruled against its petition regarding Humira, AbbVie's drug (ABBV +6.6%).
    • Amgen asked the patent office to review two formulation patents on Humira -- a rheumatoid arthritis drug with annual sales near $14B -- with the argument that they shouldn't have been granted.
    • The company had filed in November seeking approval to sell a cheaper biosimilar to Humira. It expects the first of its biosimilars in development to hit the market between 2017 and 2019.
    • Meanwhile, AbbVie says that based on its patents it doesn't expect biosimilar competition until 2022.
    • The patent office said Amgen "has not shown a reasonable likelihood of prevailing on any of its challenges."
    • After hours: AMGN is flat; ABBV is up 0.8%.
    | Thu, Jan. 14, 5:59 PM | 1 Comment
  • Dec. 17, 2015, 7:46 AM
    • Galapagos NV (NASDAQ:GLPG) and Gilead Sciences (NASDAQ:GILD) enter into a global collaboration to develop and commercialize the former's filgotinib for inflammatory indications, starting with rheumatoid arthritis (RA) and Crohn's disease.
    • Under the terms of the agreement, Galapagos will receive an upfront payment of $725M comprised of a $300M license fee paid in cash and a $425M equity investment at $58 per share (15% stake). It is also eligible to earn up to $1.35B in milestones, tiered royalties starting at 20% and a 50/50 split of the profits in co-promotion territories.
    • The firms will commence their partnership with the initiation of Phase 3 studies in RA. Galapagos will co-fund 20% of the global development activities while Gilead will be responsible for manufacturing and worldwide marketing and sales activities. Galapagos has the option to co-promote filgotinib in the UK, Germany, France, Italy, Spain, Belgium, the Netherlands and Luxembourg. If Galapagos elects to co-promote in Belgium, the Netherlands or Luxembourg, it will also book sales in these countries.
    • The Phase 3 trials in RA and Crohn's disease will commence in 2016 after discussions with regulatory authorities.
    • Filgotinib is a Janus kinase (JAK1) inhibitor. JAK1 plays an essential role in the signaling of certain pro-inflammatory cytokines. It was being developed by AbbVie (NYSE:ABBV) until it decided to develop its own JAK1 candidate.
    • Galapagos will host a conference call this morning at 11:00 am ET to discuss the deal.
    • GLPG is up 9% premarket on light volume.
    | Dec. 17, 2015, 7:46 AM | 35 Comments
  • Dec. 8, 2015, 9:17 AM
    • Galapagos NV (NASDAQ:GLPG) is up 16% premarket on light volume in response to its announcement of successful 10-week interim results in a 175-subject Phase 2 clinical trial assessing filgotinib in patients with moderate-to-severe Crohn's disease.
    • The study, FITZROY, achieved its primary endpoint of a statistically valid percentage of patients achieving clinical remission (CDAI score <150) compared to placebo. Specifically, the proportion of patients achieving clinical remission was 48% (n=61/128) for filgotinib compared to 23% (n=10/44) for placebo (p=0.0067). The proportion of clinical responders (CDAI score decreased by at least 100 points) was 60% for filgotinib versus 41% for placebo (p=0.0386).
    • Filgotinib's safety profile was consistent with previous DARWIN studies.
    • The company expects to report full 20-week results in H1 2016.
    • Filgotinib is a Janus kinase (JAK1) inhibitor. JAK1 plays an essential role in the signaling of certain pro-inflammatory cytokines. It was being developed by AbbVie (NYSE:ABBV) until it decided to develop its own JAK1 candidate.
    • Previously: Galapagos off 22% premarket on AbbVie's decision to advance ABT-494 instead of filgotinib (Sept. 25)
    | Dec. 8, 2015, 9:17 AM | 4 Comments
  • Oct. 30, 2015, 9:12 AM
    | Oct. 30, 2015, 9:12 AM
  • Oct. 30, 2015, 7:48 AM
    • AbbVie (NYSE:ABBV) Q3 results ($M): Total Revenues: 5,944 (+18.4%); U.S.: 3,690 (+31.4%); International: 2,254 (+2.0%).
    • Net Income: 1,239 (+144.9%); EPS: 0.74 (+138.7%).
    • Key Product Sales: Humira: 3,647 (+12.0%); Viekira Pak: 469 (+21.8% from Q2); Imbruvica: 304 (+184.1% from Q2); Lupron: 201 (+2.6%).
    • 2015 Guidance: EPS: $3.16 - 3.18 from $3.26 - 3.46; Non-GAAP EPS: $4.26 - 4.28 from $4.10 - 4.30.
    • 2016 Guidance: Non-GAAP EPS: $4.90 - 5.10.
    • The company also announced its long-term strategic and financial objectives today. It projects top-line revenues of ~$37B in 2020 (~10% growth per year) which includes HUMIRA sales of more than $18B and IMBRUVICA sales of ~$5B. It expects its non-GAAP operating margin to expand to >50% by 2020 compared to 36.2% in 2014.
    • Shares are up 5% premarket on average volume.
    | Oct. 30, 2015, 7:48 AM | 10 Comments
  • Oct. 22, 2015, 3:58 PM
    • AbbVie (ABBV -10.3%) slumps on a 3x surge in volume in response to the news that the FDA is warning that treatment with HCV meds Viekira Pak and Technivie can cause serious liver injury, principally in patients with advanced liver disease. AbbVie will be required to add new information about the safety risk to the products' labeling.
    • The warning was the result of the agency's review of adverse events reported to its database and to the manufacturer, which revealed cases of liver decompensation and liver failure in patients with cirrhosis who were taking the medications.  Some of the cases resulted in liver transplantation or death. Most were patients receiving Viekira Pak who had advanced cirrhosis before beginning treatment.
    • Update: In a statement, AbbVie says it has updated the U.S. package inserts for both products, changing "not recommended in Child-Pugh B patients" to contraindicated in patients with Child-Pugh B cirrhosis. Specifically, the labels now state the contraindication in patients with moderate-to-severe hepatic impairment (Child-Pugh B and C). The contraindication for Child-Pugh C for VPak was already in place. The updated label for VPak also includes a recommendation for physicians to assess evidence of hepatic decompensation prior to treatment and during treatment in cirrhotic patients.
    • Shares are down 1% after hours on robust volume.
    | Oct. 22, 2015, 3:58 PM | 57 Comments
Company Description
AbbVie, Inc. is a research-based biopharmaceutical company. It engages in the discovery, development, manufacture and sale of a broad line of proprietary pharmaceutical products. The company's products are used to treat rheumatoid arthritis, psoriasis, Crohn's disease, HIV, cystic fibrosis... More
Sector: Healthcare
Industry: Drug Manufacturers - Major
Country: United States