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AstraZeneca has announced the acquisition of French biotech firm Amolyt Pharma for up to $1.05bn to beef up its late-stage rare disease pipeline. Amolyt, which is a specialist in the treatment of rare endocrine disease, will be purchased for $800m upfront on completion of the deal, plus an additional contingent payment of $250m payable upon achievement of a specified regulatory milestone. Through the bolt-on acquisition, AstraZeneca gets its hands on eneboparatide (AZP-3601), a Phase III investigational therapeutic peptide with a novel mechanism of action designed to meet key therapeutic goals for hypoparathyroidism - a deficiency of the parathyroid hormone that results in reduced calcium and elevated phosphorus levels in the blood. Hypoparathyroidism is one of the largest known rare diseases, affecting 115,000 people in the US and 107,000 people in the EU, 80% of whom are women. "Chronic hypoparathyroid patients face a significant need for an alternative to current supportive therapies, which do not address the underlying hormone deficiency," said Marc Dunoyer, head of AstraZeneca's rare disease unit Alexion. "As leaders in rare disease, Alexion is uniquely positioned to drive the late-stage development and global commercialisation of eneboparatide, which has the potential to lessen the often debilitating impact of low parathyroid hormone and avoid the risks of high-dose calcium supplementation." AstraZeneca reckons the deal will close by the end of the third quarter of 2024, subject to "the satisfaction of customary closing conditions in the acquisition agreement, including regulatory clearances", it said.
• In the early 2010s, AstraZeneca was facing one of the largest “patent cliffs” in the pharmaceutical industry, with around half of its sales expected to lose patent protection by 2016. In 2014, the company faced further pressure as it battled to fend off an acquisition attempt from US pharmaceutical giant Pfizer.
• To combat these dual threats, management committed to reinvent the product portfolio through internal R&D with a goal of eventually doubling sales to over $45bn annually by 2023. Despite widespread scepticism, the company achieved these lofty targets (with a modest net contribution from acquisitions partially offset by unfavourable FX).
• Growth and innovation continues today, with AstraZeneca initiating 27 Phase III trial results in 2023, including ten with blockbuster potential, alongside 24 regulatory approvals in major markets and four new medicine approvals. The company expects to launch at least 15 new medicines by 2030.
• AstraZeneca’s Oncology division is one of the leading global cancer franchises, with a range of blockbuster products including Tagrisso, Lynparza and Imfimzi. Cancer is the second leading cause of death globally with an estimated 20 million people diagnosed annually, a number that is set to rise to almost 28 million a year by 2040. We expect growth in Enhertu, a targeted treatment for breast cancer, alongside as-yet-unreleased oncology treatments to drive sales growth in the medium term in this division.
• AstraZeneca’s BioPharmaceuticals division is comprised of three subdivisions: Cardiovascular, Renal & Metabolism; Respiratory & Immunology, and Vaccines & Immune Therapies. Key products include Farxiga for Type-2 diabetes and Fasenra for asthma. In both cases there remains a significant unmet need globally.
• Following completion of the $39bn Alexion acquisition in July 2021, AstraZeneca began reporting sales for its new Rare Disease division. It’s leading blockbuster, Soliris, which treats a range of rare diseases, is gradually being replaced in some cases by Ultomiris, also now a blockbuster. Of the over 7,000 rare diseases that have been identified, only approximately 5%
• One area of concern for all drug companies is pricing headwinds. In the all-important US market, there are credible plans to lower branded drug costs after years of inaction, although we believe change will be slow and AstraZeneca will be relatively well placed given US revenues are 42% of total sales, lower than many global pharmaceutical peers.
AstraZeneca reported strong first-half growth on Friday, despite challenges related to the decline of Covid-19 medicines. The FTSE 100 company said total revenue for the six months reached $22.3bn, representing a 4% increase. It noted that the growth was achieved despite a decline of $2.18bn attributed to Covid-19 medicines. Excluding the impact of Covid-19 medicines, AstraZeneca still reported a 16% increase in total revenue, and a 15% improvement in product sales. AstraZeneca said the strong performance extended across its various therapeutic areas, with oncology medicines seeing a 22% increase in total revenue, followed closely by cardiovascular, renal and metabolism (CVRM) at 20%, respiratory and immunology (R&I) at 10%, and rare disease at 12%. The firm also reported an encouraging improvement in core product sales gross margin, which stood at 83%, reflecting a three-percentage-point increase. Its core earnings per share jumped 21%, reaching $4.07, as the company maintained its interim dividend at 93 US cents. Looking ahead, AstraZeneca reiterated its guidance for the full year. "Each of our non-Covid-19 therapy areas saw double-digit revenue growth, with eight medicines delivering more than $1bn of revenue in the first half, demonstrating the strength of our business," said chief executive officer Pascal Soriot. "Several medicines grew rapidly including Ultomiris, Imfinzi/Imjudo and Farxiga, with revenues up 64%, 57% and 40% respectively." Soriot said AstraZeneca's pipeline momentum was continuing, with eight positive pivotal trials for its oncology medicines so far this year, adding that the company was encouraged by the positive data from 'TROPION-Lung01' - the first pivotal trial of datopotamab deruxtecan. "We look forward to sharing the data with the medical community at an upcoming medical congress and are proceeding to file the data with the US Food and Drug Administration."
He drugmaker began discussions with lenders several months ago, although a spinoff may not materialize, the report said. AstraZeneca (AZN) may also consider listing the business in Shanghai.
A separate listing would insulate the business from any potential crackdown on foreign companies in China.
The domestic listing could also help AstraZeneca (AZN) win faster approvals for therapies developed in China.
"Every multinational with a strong China business" seems to have considered a similar move, a senior banker told FT. "Even if it's just the option to give you flexibility in the future, it's worth thinking about."
"We do not comment on rumors or speculations around future strategy or M&A," an AstraZeneca (AZN) spokesperson told Seeking Alpha in an emailed statement.
Financial performance (Q1 2023 figures unless otherwise stated, growth numbers at CER)
? Total Revenue stable at $10,879m, despite a decline of $1,460m from COVID-19 medicines
? Excluding COVID-19 medicines, Total Revenue increased 15% and Product Sales increased 16%
? Total Revenue from Oncology medicines increased 19%, CVRM7 22%, R&I8 8%, and Rare Disease 14%
? Core Gross margin of 83%, up four percentage points, reflecting the decline in sales of lower margin COVID-19 medicines, the cost of production in prior periods, and a mix shift to more speciality medicines
? Core Operating margin of 36%, up one percentage point, reflecting a $220m increase in Core Other operating income, which included a gain from the divestment of Pulmicort Flexhaler rights in the US
? Core EPS increased 6% to $1.92
? Reiterating guidance for FY 2023 Total Revenue and Core EPS
https://www.astrazeneca.com/media-centre/press-releases/2023/q1-2023-results.html
Not an easy question to answer. It really does depend on your time horizon.
I would say that if you are looking to buy and hold then todays price may seem quite cheap in ten years time, but may not in only a years time.
Bear in mind that in the short term high returns are only available from companies that carry high risk and if an established company looks cheap there is probably a good reason for that.
My portfolio holds many Pharma companies but it is a holding that I have built up over a 30 year period. I do hold other stacks in addition. Some are doing very well and others less so.
Lex in the FT was drawing a direct comparison with the troubles of Bayer with "Roundup" litigation .
To declare in interest I sold out my entire holding last week after holding them since I don't know when.
Analysts at ShoreCap reiterated their 'buy' recommendation for shares of drugs giant AstraZeneca, describing its second quarter top-line growth of 37% year-on-year at constant exchange rates "impressive". "AZN have delivered a strong second quarter, with Q2 benefitting from a full quarter of Alexion integration and several products beating consensus expectations," analyst Dr.Susie Jana said in a research note sent to clients. "Oncology was in line overall due to strong commercial execution and lower COVID-19 related headwinds than anticipated." The analyst also called attention to the fact that AstraZeneca was reinvesting its strong revenues into research and development. And there was more yet to come. "AZN has a strong mid to late-stage pipeline, we expect product and candidate related news flow in 2023 to lead to further upgrades. A strong set of results underpinning the long-term growth story," she added. "AZN shares trade on a FY23F PER of 16.8x, a c 5% premium versus US and European peers (mean 16.1x), which we believe is warranted based on its industry-leading earnings growth and pipeline prospects."
(Sharecast News) - Credit Suisse has initiated coverage of Haleon, GlaxoSmithKline's recently spun out consumer healthcare arm, at 'outperform' with a 368p price target.
The bank said Haleon is a "highly attractive" company. It said that as the only listed pure-play in Consumer Health - an industry with structural growth trends - Haleon's current valuation fails to recognise the company's scope to deliver above-guidance organic sales growth of 6.5% in FY22, followed by 4.5% in FY23.
It also fails to recognise the improved portfolio of the business (post recent M&A and divestments) and its ability to leverage scale as the clear global leader, with a market share twice that of its nearest competitor.
Credit Suisse said that based on its analysis of more than 100 country/category cell forecasts, it expects Haleon to deliver 4.2% organic sales growth per annum over the medium term, which reflects around 10 basis points a year market-share expansion.
CS said Haleon has high-quality earnings growth potential of circa 7.5% per year, benefitting from further margin expansion and reduced interest cost.
"Compared to consumer staples, the company has a relatively low exposure to input costs (less than 10% of sales) and emerging market currencies, and is likely more resilient in an economic downturn, in our view," it said.
It added that the step-up in cash conversion should allow the group to de-lever quickly.
I originally got my Standard Life shares as a policy holder when they demutualised. These then became Abrdn shares following the merger.
Can anyone remember what the value was at that time?
I have recently sold my Abrdn and I am trying to work out whether I have a CGT liability in the sale.
UBS research on Tuesday downgraded AstraZeneca (NASDAQ:AZN) stock to neutral from buy, citing no major catalysts on their radar for the Anglo-Swedish drug giant until Q1 next year.
U.S.-listed shares of AZN were down 1.3% at $59.22 in mid-day trading amidst mixed broader markets.
"On the back of impressive trial results for (cancer drugs) Lynparza and Enhertu, AZN has outperformed the global large cap peer group by 120bps this year," said UBS analysts Michael Leuchten, Laura Sutcliffe and Colin White.
However, the stock is now in more "sensible territory," the analysts said, adding that the rest of the year would be more about commercial execution.
"In times of reduced pipeline noise, the market tends to focus more on AZN's margin progression and we suspect this time it will be no different with some additional debate around the trajectory in China," they said.
UBS said now that major trial readouts for the year were done, the focus would return to the performance of Lynparza, along with other cancer drugs Tagrisso and Calquence.
Calquence, Lynparza and Tagrisso brought in total revenue of $414M, $792M and $1.30B, respectively, for AZN in Q1.
The UBS analysts also said that they see little potential for Alexion to deliver any meaningful upside. AZN completed its acquisition of U.S.-based Alexion in July last year.
Up to Monday's close, AZN stock +3% YTD.
Analysts at JP Morgan hiker their target price for shares of AstraZeneca and pointed to the potential for "significant" future upward revisions to analysts' estimates for the profitability of the company's oncology pipeline. The latter, they said, should help drive a further re-rating in the share price. In particular, they focused on the potential for Enhertu and DS-1062 Antibody Drug Conjugate for HER2-expressing cancer and TROP2-expressing cancer, respectively. Combined, they forecast the two treatments were capable of generating combined in-market peak annual sales of over $20bn - shares with partner Daiiichi - with the potential for significant long-term upgrades over the following 12 months. For Enhertu, a DB-04 PIII data presentation was scheduled for June 2022, headline DB-06 PIII data in mid-2023 and additional readouts in 2024-25. In the case of DS-1062, the first PIII data was expected in late 2022 or early 2023 with read-through to further PIII data in approximately 2025. On the back of all of the above, JP Morgan raised its target price for the shares from 10,000.0p to 12,000.0p and reiterated its 'overweight' rating. The analysts' estimates for Enhertu and DS-1062 were 20% and 75% ahead of the company consensus for 2027.
Drugmaker AstraZeneca revealed on Tuesday that its Ondexxya asset had become the first approved medicine in Japan to specifically reverse the anticoagulant effect of Factor Xa inhibitors, providing "a major advance" in the treatment of patients hospitalised with life-threatening bleeding. AstraZeneca stated the approval by the Japanese Ministry of Health, Labour and Welfare was based on positive results from its ANNEXA-4 Phase III clinical trial, which showed Ondexxya "rapidly and markedly" reversed anti-FXa activity in patients with acute major bleeding. Ondexxya received US approval from the Food and Drug Administration under the accelerated approval pathway in May 2018 and conditional approval by the European Commission in April 2019 for adults treated with FXa inhibitors apixaban and rivaroxaban. Mene Pangalos, AstraZeneca's executive vice president of biopharmaceuticals R&D, said: "With the approval of Ondexxya in Japan, we are working to make this important medicine available as quickly as possible for the small proportion of patients with life-threatening or uncontrolled bleeding who are on FXa inhibitors and who have not previously had an approved reversal agent treatment option."
AstraZeneca's rare disease unit has entered into a settlement agreement with Chugai Pharmaceutical, resolving all patent disputes between the two companies related to long-acting C5 complement inhibitor, Ultomiris (ravulizumab). In accordance with the settlement agreement, AZN's Alexion wing and Chugai have both taken steps to withdraw patent infringement proceedings filed in the US with the District Court of Delaware and in Japan with the Tokyo District Court. Under the terms of the agreement, Alexion will make a single payment of $775.0m in the second quarter of 2022, for which a charge will be recognised through non-core profit and loss in the first quarter of 2022. AZN added that no further amounts will be payable by either party and said the settlement did not impact the group's financial guidance for 2022. Alexion chief executive Marc Dunoyer said on Thursday: "With this settlement, we will continue to advance our Ultomiris development programmes in new indications and focus on our mission to transform the lives of people affected by rare diseases."
AstraZeneca said on Monday that Lynparza candidate had been approved in the US as an adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer. AstraZeneca said on Monday that the approval by the Food and Drug Administration was based on results from its OlympiA Phase III trial, which demonstrated a "statistically significant and clinically meaningful improvement" in invasive disease-free survival, reducing the risk of invasive breast cancer recurrences, second cancers or death, by 42% versus a placebo. AZN's Dave Fredrickson said: "This important approval gives early-stage breast cancer patients in the US with a germline BRCA mutation a new targeted therapy option in the adjuvant setting starting today. "Lynparza reduces the risk of disease recurrence in these high-risk patients and now new data confirm it also significantly extends patients' lives versus placebo. These data underline the importance of germline BRCA testing as soon as possible after diagnosis to identify patients that may be eligible for Lynparza." Separately, AstraZeneca said the Food and Drug Administration had issued a complete response letter regarding the supplemental Biologics License Application for its Fasenra candidate for patients with inadequately controlled chronic rhinosinusitis with nasal polyps. The letter requested AZN supply additional clinical data, with the company now working closely with the FDA regarding next steps as it "remains committed to bringing Fasenra to patients". A second Phase III trial on the drug was ongoing
Drugmaker AstraZeneca said on Tuesday that its rare diseases subsidiary had closed an exclusive global collaboration and licence agreement with Neurimmune for NI006, an investigational human monoclonal antibody currently in Phase Ib development.
AstraZeneca said its Alexion subsidiary had been granted an exclusive worldwide licence to develop, manufacture and commercialise NI006, which will be used for the treatment of transthyretin amyloid cardiomyopathy, an under diagnosed, systemic condition that leads to progressive heart failure and a high rate of fatality within four years from diagnosis.
Under the terms of the agreement, Alexion will make an upfront payment of $30.0m to Neurimmune, while there will also be additional contingent milestone payments of up to $730.0m upon achievement of certain development, regulatory and commercial milestones. It will also pay "low-to-mid teen royalties" on net sales of any approved medicine resulting from the collaboration.
AZN added that Neurimmune will continue to be responsible for the completion of the current Phase Ib clinical trial, while Alexion will pay certain trial costs and be responsible for further clinical development, manufacturing and commercialisation following the trial.