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Update: AstraZeneca Wins EC Marketing Authorization For Duaklir GenuairTrevor Lowenthal • Yesterday, 5:35 AM
- AstraZeneca announced EU Marketing Authorization for Duaklir Genuair on Monday.
- I reiterate my bull thesis on AstraZeneca.
- As expected, AstraZenca continues to improve its growth prospects as an independent pharmaceutical company. Monday's announcement corroborates this position.
Update: AstraZeneca Q3 Earnings Fail To Impress, But Long-Term Prospects Remain IntactTrevor Lowenthal • Fri, Nov. 7
- Astra reported Q3 earnings on Thursday.
- I reiterate my bull thesis on Astra.
- As expected, Astra remains fully capable of earnings growth independent of Pfizer. The latest earnings report corroborates this position.
- AstraZeneca may not receive a fresh offer from Pfizer in the wake of new tax rules announced by the Treasury.
- AstraZeneca though looks attractive even without a bid from Pfizer.
- The company recently received approval for Xigduo XR in the U.S. and has also sealed the Almirall transaction.
- AstraZeneca’s oncology portfolio also looks promising, with olaparib recently receiving positive recommendation in the European Union.
- There is 10%-12% upside potential in AstraZeneca shares in the near-term.
- AstraZeneca announced today FDA approval for its diabetes combo pill Xigduo XR.
- I reiterate my bull thesis following the approval.
- As expected, AstraZeneca continues to enhance its growth prospects, thus supporting my thesis that it can thrive independent of Pfizer.
Update: AstraZeneca Receives Positive EMA Recommendation For Olaparib
- AstraZeneca announced Friday the EU recommendation for approval for Olaparib.
- I reiterate my bull thesis, as Astra continues to increase its growth prospects.
- As expected, the company continues to demonstrate its viability independent of Pfizer. The positive EU recommendation corroborates this position.
Update: AstraZeneca Moves Closer To EU Approval For Moventig
- AstraZeneca announces a positive EMA opinion for Moventig.
- I reiterate my bull thesis on AstraZeneca given the market potential in the EU for this opioid-induced constipation drug.
- The positive EMA opinion follows the recent FDA approval for Moventig.
- AstraZeneca announced today a licensing agreement with Eli Lilly for AZD3293 to target Alzheimer's disease.
- I reiterate my bull thesis on AstraZeneca given the value proposition of this arrangement.
- I didn't anticipate this agreement in my initial report.
AstraZeneca Has 30% Upside As A Takeover Candidate
- Pfizer's last bid for AstraZeneca is a 27% premium over the current stock price.
- Talks may resume as early as this month if AstraZeneca is interested, but are more likely to resume in November.
- This deal is beneficial to AstraZeneca's shareholders over the short-term, but is likely to hinder innovation at the combined company over the long-term.
- AstraZeneca has an attractive drug pipeline and is expecting to grow revenues 7.5% annually as a result of this pipeline.
- Pfizer has been slashing R&D spending and is in desperate need of a drug pipeline to carry its company into future success.
Update: AstraZeneca's Earnings Beat Reaffirms Bull Thesis
- AstraZeneca is attempting to make an earnings comeback after being hindered by a series of patent expirations, which has taken a toll on revenues.
- Pfizer isn't budging with respect to unveiling whether it still has plans to acquire AstraZeneca after the 3-to-6-month waiting period.
- Regardless, AstraZeneca is proving that it can exceed expectations independent of Pfizer, pursuant to the latest earnings report. Thus, I reaffirm my bull thesis in light of strong earnings performance.
- AZN is a solid company with a fine management team, but is a poor investment choice at its current stock price given its uncertain future.
- Unfavorable politics and negative sentiment in the US and UK make another offer for AZN by Pfizer unlikely in 2014.
- Conservative estimates of revenues in 2023 are $31 billion vs. company estimates of $45 billion.
- At the current price of $73, investors are paying for hope on a pipeline that won't deliver significant revenues for at least 5 years.
- AstraZeneca tumbled after rejecting Pfizer's "final" bid, and considerable risks remain.
- Nevertheless, both its impressive dividend yield of 5.30% and extensive pipeline keep me interested.
- To take advantage of its high yield, I have constructed a conservative yield-enhancing strategy that reduces risk and provides investors with peace of mind.
AstraZeneca Continues To Benefit From Pfizer Courtship
- Pfizer made a generous new offer to acquire AstraZeneca for $106 billion in cash and shares.
- Pfizer CFO Frank D'Amelio revealed that every option, including a hostile takeover, remains on the table when it comes to buying AstraZeneca.
- Pfizer’s attention, in addition to strong fundamentals and innovation at AstraZeneca, will likely continue to be a boon for AstraZeneca shares.
Pfizer And AstraZeneca: Innovation Will Not Follow Acquisition
- PFE is unsuccessfully courting AZN to the tune of $100 billion and may soon invest in a hostile bid.
- R&D productivity is declining for the pharmaceutical industry in general and is worse for larger than smaller companies.
- Consolidation is a common strategy to stave off slowing growth but is seen to further decrease R&D productivity.
- PFE's acquisition of AZN will result in large tax savings but will also stifle innovation, which is the chief driver of growth.
- Pfizer recent overture to acquire Astra Zeneca makes financial sense.
- The combined companies would be still be facing immediate difficulty in increasing revenues.
- The combination is a long term play as the pipeline should bear fruit in the 2017 time frame.
- AstraZeneca’s diabetes drug Symlin may one day enter the $6 billion Alzheimer’s drug market.
- There are over 5 million Americans suffering from Alzheimer’s.
- AstraZeneca is in need of a blockbuster drug to offset its patent cliff.
- AstraZeneca offers one of the best dividends on the market.
Yesterday, 4:47 PM
- Amgen (AMGN -1.2%) and development partner AstraZeneca (AZN -0.6%) announce that the Amagine-2 Phase 3 trial evaluating two doses (210 mg and 140 mg every two weeks) of brodalumab in patients with moderate-to-severe plaque psoriasis met its primary endpoints compared to J&J's (JNJ -0.1%) Stelara (ustekinumab) and placebo at week 12. The 210 mg arm and the weight-based analysis group both demonstrated superiority to Stelara on achieving total skin clearance as measured by the Psoriasis Area Severity Index (PASI 100 or 100% reduction in score).
- 44.4% of patients in the brodalumab 210 mg group, 33.6% in the brodalumab weight-based group, 25.7% of patients in the brodalumab 140 mg group, 21.7% of patients in the Stelara group and 0.6% of patients in the placebo group achieved PASI 100. PASI 75 (75% reduction in score) scores for the same groups were: 86.3%, 77.0%, 66.6%, 70.0% and 8.1%, respectively.
- All secondary endpoints comparing brodalumab to placebo were also met. The first major secondary endpoint comparing PASI 100 for brodalumab 140 mg against Stelara at week 12 was numerically greater but not statistically significant (p=0.078). The remaining secondary endpoints for the 140 mg group versus Stelara were also numerically greater (all p values<0.05) but could not be considered statistically significant due to the sequential testing method.
- Previously: Positive Phase 3 results for brodalumab
- Previously: Amgen's brodalumab beats Stelara in Phase 3 trial
Yesterday, 8:18 AM
- Pharmacy benefits manager Express Scripts (NASDAQ:ESRX) is at the forefront of an increasing wave of resistance to the high prices of new drugs from pharma and biotech firms, some which cost as much as $50K per month. Pharmaceutical spending in the U.S. is $270B and may breach $500B in five years. ESRX's method of controlling costs is to refuse to pay for them. For 2015, for example, it is excluding 66 branded drugs from its main formulary, an increase of 18 from 2014's 48. On the list is Johnson & Johnson's (NYSE:JNJ) rheumatoid arthritis drug Simponi (golimumab) which costs $3K per month.
- Other prescription benefits managers are employing similar tactics. CVS Health (NYSE:CVS) will exclude 95 drugs from its 2015 formulary including Pfizer's (NYSE:PFE) multiple sclerosis med Rebif (interferon beta-1a) which costs $5K for a four-week supply.
- Governments are pushing back as well. Among 42 state Medicaid programs, 27 pay for Gilead Sciences' HCV med Sovaldi (sofosbuvir) only for patients with severe liver damage while others impose coverage limitations for patients with recent substance-abuse problems. In the U.S., the full regimen cost is $84K. Recently, Britain's National Institute for Health and Care Excellence (NICE) balked at recommending reimbursement for Roche's (OTCQX:RHHBY) blood cancer drug Gazyvaro (obinutuzumab).
- Ninety percent of commercial health plans require pre-approval of specialty drugs, up from 82% in 2011.
- Previously: Roche's Gazyvaro not NICE in the UK
- Previously: Global drug tab will breach trillion dollar mark this year
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Related tickers: (NYSE:NVS) (NYSE:AZN) (NASDAQ:AMGN) (NASDAQ:BIIB) (NASDAQ:CELG) (NYSE:LLY) (NYSE:SNY) (NYSE:ABT) (NYSE:ABBV) (NYSE:BMY) (NYSE:MRK) (NYSE:GSK)
Mon, Nov. 24, 8:02 AM
- The European Commission approves AstraZeneca's (NYSE:AZN) Duaklir Genuair (aclidium bromide/formoterol fumarate 340/12 mcg) for the maintenance bronchodilator treatment in adults with chronic obstructive pulmonary disease (COPD).
- The product is a fixed dose combination of two approved long-acting bronchodilators with different mechanisms of action. Aclidium bromide is an anticholinergic or long-acting muscarinic antagonist that produces bronchodilation by inhibiting the muscarinic M3 receptor in the airway smooth muscle. Formoterol fumarate is a long-acting beta-agonist that stimulates the B2-receptors in the bronchial smooth muscle resulting in bronchodilation. Both are currently approved as stand-alone therapies for the maintenance treatment of COPD in the U.S. and Europe.
- Genuair is a multi-dose pre-loaded dry powder inhaler that utilizes optical and acoustic signals to inform the patient that the correct dose has been delivered.
- COPD-related tickers: (NYSE:GSK) (NYSE:NVS) (NASDAQ:THRX) (NASDAQ:REGN) (NYSE:SNY) (NYSE:TEVA) (OTCQX:RHHBY)
Tue, Nov. 18, 10:52 AM
- AstraZeneca (AZN +1.2%) Chief Pascal Soriot will present his plan to deliver $45B in top-line revenues by 2023 to investors today at 1:30 pm ET.
- The company has 14 potential new medicines in Phase 3 development or registration, a potential 14 - 16 submissions and 8 - 10 approvals in the next two years. AZD9291 FDA submission expected in Q2 2015.
- It has 13 combination trials underway with 16 planned in its immuno-oncology portfolio.
- Five current platforms - Brilinta, diabetes, respiratory, Emerging Markets and Japan - account for more than 50% of global revenues. Oncology will be the sixth growth platform.
- Biologics account for almost half of its pipeline, growing focus on devices, portfolio balanced between primary and specialty care to boost profitability.
- Value to be created via partnerships and licensing in neuroscience and infection.
- Previously: AstraZeneca forecasts $45B in annual sales by 2023
Tue, Nov. 18, 4:35 AM
- Ahead of a six-hour investor meeting later today, AstraZeneca (NYSE:AZN) has reiterated that it expects annual sales to rise by three quarters and exceed $45B by 2023, a forecast it first gave after seeing off a $118B bid from Pfizer in May.
- "We have more than doubled the number of potential medicines in our late-stage pipeline since 2012 and we are on track to return to growth by 2017," says Chief Executive Pascal Soriot.
- AZN -1.1% premarket
Mon, Nov. 17, 4:06 AM
- Pfizer (NYSE:PFE) will pay $850M for rights to a cancer drug being developed by Merck (NYSE:MRK), puncturing investor expectations of a renewed bid for AstraZeneca (NYSE:AZN).
- As a result of the upfront payment, Pfizer has lowered its forecast of 2014 EPS to $1.40-$1.49 from $1.50-$1.59.
- The agreement also calls for Pfizer to pay as much as $2B to Merck if the immunotherapy drug, known as MSB0010718C, meets commercial and regulatory goals.
Fri, Nov. 14, 10:38 AM
- Dow Chemical (DOW +1%) says it "fundamentally disagrees" with the position outlined by Dan Loeb's Third Point hedge fund in its latest statement and new website, which the company says reflect the views of "an activist investor that has little interest in anything that benefits [Dow's] many long-term shareholders."
- Jim Cramer is now a fan of Dow, citing the company as an example of a buyback done right; combining Dow's $5B increase in its buyback plan with its total repurchase authorization totals ~17% of market cap.
- Cramer also sees buyback opportunities in FLEX, JACK, M, DIS, KMB, VIA, DPS and AZN.
Wed, Nov. 12, 11:13 AM
- Advaxis (ADXS +1.8%) files an Investigational New Drug Application (IND) with the FDA to conduct a Phase 1/2 clinical trial of ADXS-HPV (ADXS-11-001) alone or in combination with MedImmune's (AZN -0.1%) investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, for the treatment of advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer.
- The Phase 1 portion will establish a recommended dose regimen of ADXS-HPV with MEDI4736 and the Phase 2 portion will evaluate the safety and efficacy of the combination. The study is expected to start in early 2015.
Tue, Nov. 11, 4:52 PM
- A Phase 3 study evaluating Amgen's (NASDAQ:AMGN) brodalumab versus Janssen's (NYSE:JNJ) Stelara (ustekinumab) and placebo at week 12 in patients with moderate-to-severe plaque psoriasis met its primary endpoints. Brodalumab was superior to ustekinumab in achieving total clearance of skin disease as measured by PASI-100. Compared to placebo, a significantly greater proportion of patients treated with brodalumab achieved at least a 75% improvement from baseline in disease severity at week 12 (measured by PASI-75). All key secondary endpoints were also met.
- Proportion of patients achieving total clearance of disease: brodalumab-210 mg: 36.7%; brodalumab-140 mg: 27.0%; Stelara: 18.5%; placebo: 0.3%.
- Proportion of patients achieving PASI-75: brodalumab-210 mg: 85.1%; brodalumab-140 mg: 69.2%; Stelara: 69.3%; placebo: 6.0%.
- Amgen plans to present the complete results at a future medical conference.
- Related tickers: (NYSE:AZN) (NYSE:GSK) (NASDAQ:CELG) (NYSE:NVS) (NASDAQ:DERM) (NASDAQ:IDRA) (NYSE:HSP) (NYSE:PFE) (NYSEMKT:CANF) (NYSE:MRK)
Tue, Nov. 11, 7:44 AM
- Dupilumab, a fully-human monoclonal antibody being co-developed by Sanofi (NYSE:SNY) (OTCQB:SNYNF) and Regeneron Pharmaceuticals (NASDAQ:REGN), showed showed positive results in a 776-patient Phase 2b dose-ranging clinical trial in adults with moderate-to-severe uncontrolled asthma.
- The three highest doses of dupilumab in combination with standard-of-care therapy met the primary endpoint of a statistically significant improvement from baseline in forced expiratory volume over one second (FEV1) at week 12 in patients with high blood eosinophils (>= 300 cells/microliter) compared to placebo in combination with standard-of-care therapy. Also, two doses of dupilumab (200 mg every other week and 300 mg every other week) showed a statistically significant improvement in mean percent change in FEV1 and a reduction in severe exacerbations, both in the high eosinophils group and the overall study population.
- Dupilumab blocks IL-4 and IL-13, two cytokines required by the Th2 immune response. Some researchers believed that targeting the Th2 pathway would limit the benefit in asthmatics with high eosinophils, but this study demonstrated that it could be effective. Final results from the trial will be presented at a future medical conference.
- Sanofi plans to proceed to Phase 3 development.
- Asthma-related tickers: (NYSE:GSK) (NYSE:TEVA) (NYSE:AZN) (OTCQX:RHHBY) (NASDAQ:AMGN) (NYSE:MRK) (NYSE:NVS) (NASDAQ:THRX)
Mon, Nov. 10, 1:46 PM
- San Francisco, CA-based FibroGen (Pending:FGEN) is on deck for its IPO of 7.1M shares of common stock at $16 - 19.
- The biopharmaceutical company focuses on fibrosis and hypoxia-inducible factor (HIF) biology. Its lead product is roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylases currently in Stage 3 development, for the treatment of anemia in patients with chronic kidney disease. Its second product candidate is FG-3019, a monoclonal antibody in Phase 2 development for the treatment of idiopathic pulmonary fibrosis.
- The company's development and commercialization partners for roxadustat are Astellas Pharma (OTCPK:ALPMF) (OTCPK:ALPMY) (Japan, Europe, CIS, Middle East, South Africa) and AstraZeneca (AZN +0.6%) (U.S., China, ROW ex. Astellas territories).
- 2013 Performance ($M): Revenues: 102.2 (+55.1%); Operating Expenses: 110.1 (+18.1%); Net Loss: (14.9) (+54.3%); CF Ops: 25.9 (+562.5%).
- 2014 Performance (9 mo.): Revenues: 121.5 (+35.3%); Operating Expenses: 123.6 (+69.8%); Net Loss: (8.9) (-175.4%); CF Ops: 46.2 (-4.9%).
- ETFs: IBB, BIB, BIS (NYSEARCA:IPO)
Thu, Nov. 6, 8:51 AM
- AstraZeneca (NYSE:AZN) Q3 results ($M): Revenues: 6,542 (+4.7%); Gross Profit: 5,127 (+2.3%); Operating Income: 541 (-68.3%); Net Income: 253 (-79.7%); EPS: 0.20 (-79.8%); CF Ops (9 mo.): 5,216 (+6.0%).
- Revenue by region: U.S.: 2,528 (+7.1%); Europe: 1,648 (+1.1%); Established ROW: 898 (-4.6%); Emerging Markets (incl. China): 1,468 (+11.3%); China: 558 (+19.5%).
Thu, Nov. 6, 8:31 AM
- Aegerion Pharmaceuticals (NASDAQ:AEGR) acquires Myalept (metreleptin for injection) from AstraZeneca (NYSE:AZN) for $325M. The drug is indicated for the treatment of leptin deficiency in patients with generalized lipodystrophy. It is the first and only product approved in the U.S. to treat the disease.
- Myalept has Orphan Drug status in the U.S., European Union and Japan.
Thu, Nov. 6, 8:03 AM
- In a setback for India's generic drug firm Ranbaxy Laboratories Ltd., the FDA revokes its previously granted tentative approvals for its lower cost versions of AstraZeneca's (NYSE:AZN) heartburn med Nexium and Roche's (OTCQX:RHHBY) antiviral Valcyte.
- The agency informed the company that while there were no data integrity issues related to its filings, its decisions granting the approvals were "in error."
- The revocation also terminates its six-month first-to-file market exclusivity.
- Management says in a statement, "Ranbaxy is disappointed with this development and is actively evaluating all available options to preserve its rights."
Thu, Nov. 6, 4:54 AM
- AstraZeneca (NYSE:AZN) raised its 2014 sales forecast for the second quarter in a row, as the delayed arrival of Nexium generics in the U.S. kept cash flowing from the heartburn and ulcer pill.
- The company said full-year revenue was now expected to increase in low single-digits, compared with previous guidance for sales to be in line with 2013.
- However, profit excluding certain items fell during the quarter, declining 13% Y/Y to $1.77B from $2.03B.
- AstraZeneca also announced a $325M upfront payment from Aegerion Pharmaceuticals, after agreeing to sell its rare disease drug Myalept.
- AZN -1.4% PM
Wed, Nov. 5, 5:30 PM
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