Astraceneca, Year-to-date and Q3 2021 results.

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Algemeen advies 12/11/2021 17:29
AstraZeneca reinforces its scientific leadership through exceptional
pipeline delivery and the addition of Alexion in the quarter
- Total Revenue in the year to date, including Alexion from 21 July 2021, was $25,406m, representing growth
of 32% (28% at CER). Total Revenue in the third quarter increased by 50% (48% at CER) to $9,866m
- Excluding the pandemic COVID-19 vaccine, Total Revenue increased 21% (17% at CER) in the year to date
to $23,187m, and by 34% (32% at CER) in the quarter to $8,816m
- Eight positive Phase III results since June, with potential to change standard of care in several diseases
- Alexion integration progressing well, creating new opportunities in rare diseases
- Operating Expenses in the quarter reflected the addition of Alexion, as well increased R&D expenses across
multiple programs, investment in our COVID-19 medicines, and increased SG&A from pre-launch activities
following successful pipeline delivery
- Earnings guidance for the full year is unchanged
In the year to date, AstraZeneca delivered double-digit revenue growth from its Oncology, CVRM1 and R&I2
medicines, and established its Rare Disease capability with the acquisition of Alexion Pharmaceuticals Inc.
(Alexion). Rare disease is a high-growth area with rapid innovation and significant unmet medical need.
Since June, AstraZeneca has made significant progress with its late-stage pipeline, reporting eight positive
Phase III trial results and the approval of Saphnelo (anifrolumab) in the US for the treatment of systemic lupus
erythematosus, and Ultomiris in the EU for children and adolescents with paroxysmal nocturnal
haemoglobinuria. Enhertu received a Breakthrough Therapy Designation from the US FDA3
ground-breaking results from the DESTINY-Breast03 trial. The Company also announced positive results for
Lynparza in prostate cancer, Imfinzi plus tremelimumab in liver cancer, Imfinzi in biliary tract cancer, PT027 in
asthma, ALXN1840 in Wilson disease, and AZD7442 in COVID-19 prophylaxis and treatment.
Pascal Soriot, Chief Executive Officer, commented:
“AstraZeneca’s scientific leadership continues to provide strong revenue growth and exceptional pipeline
delivery, with eight positive late-stage readouts across seven medicines since June, including our long acting
antibody combination showing promise in both prevention and treatment of COVID-19. The addition of Alexion
furthers our commitment to bring transformative therapies to patients around the world, and I am proud of our
colleagues’ ongoing dedication and focus.
Our broad portfolio of medicines and diversified geographic exposure provides a robust platform for long-term
sustainable growth. Following accelerated investment in upcoming launches after positive data flow, we expect
a solid finish to the year and our earnings guidance is unchanged.”
Table 1: Revenue and EPS summary
YTD 2021 Q3 2021
Actual % CER4 % Actual % CER %
$m Change change $m Change change
- Product Sales 25,043 33 29 9,741 49 47
- Collaboration Revenue 363 10 10 125 n/m n/m
Total Revenue 25,406 32 28 9,866 50 48
- Less pandemic COVID-19 vaccine5 2,219 n/m6 n/m 1,050 n/m n/m
Total Revenue ex-pandemic vaccine7 23,187 21 17 8,816 34 32
Reported8 EPS9 $0.33 (80) (65) $(1.10) n/m n/m
Core10 EPS $3.59 22 23 $1.08 14 15
Impact of pandemic vaccine on EPS $(0.03) n/m n/m $0.01 n/m n/m

Key elements of Total Revenue performance in the year-to-date included:
- An increase in Product Sales of 33% (29% at CER) to $25,043m
- The first contribution from Rare Disease, which generated $1,311m of revenue in the period following
completion of the Alexion acquisition on 21 July 2021
- Oncology growth of 19% (16% at CER) to $9,744m, CVRM growth of 14% (10% at CER) to $6,028m and
R&I growth of 16% (12% at CER) to $4,456m
- An increase in Emerging Markets revenue of 33% (28% at CER) to $8,618m. In China, revenue increased
17% (8% CER) to $4,699m in the year to date and by 10% (2% CER) in the quarter. China revenues in the
year to date were impacted by pricing pressure associated with NRDL11 and VBP12 programmes.
- Tagrisso’s sequential quarterly performance in China was impacted by inventory phasing and stock
compensation relating to NRDL changes in March. In future periods, volume growth from increased patient
access is expected to compensate for the lower NRDL price
- Revenue in ex-China Emerging Markets increased 60% in the year to date to $3,919m. Excluding vaccine
revenue of $1,139m, revenue in ex-China Emerging Markets increased by 13% in the year to date (14% at
CER) to $2,780m and by 30% in the quarter to $1,018m, driven by Oncology medicines and Farxiga
- In the US, Total Revenue increased by 29% to $8,305m and in Europe by 40% (31% at CER) to $5,178m,
including pandemic COVID-19 vaccine revenue of $736m
The Company provides further details on its FY 2021 guidance at CER.
Total revenue excluding the COVID-19 vaccine is expected to grow by a low-twenties percentage, in line with prior
guidance. Including vaccine revenues in Q4 2021, revenue is expected to grow by a mid-to-high twenties percentage.
Growth in Core EPS13 to $5.05 to $5.40, in line with prior guidance.
Prior guidance excluded the revenue and profit impact of sales of the pandemic vaccine. The Company is now
expecting to progressively transition the vaccine to modest profitability as new orders are received. COVID-19
vaccine sales in Q4 2021 are expected to be a blend of the original pandemic agreements and new orders, with
the large majority coming from pandemic agreements. The limited profit contribution from the vaccine in Q4
2021 is expected to offset costs relating to the Company’s long acting antibody combination (AZD7442),
resulting in no change to Core EPS guidance. Core Tax Rate guidance is unchanged at 18-22%.
In general, AstraZeneca continues to recognise the heightened risks and uncertainties from the effects of
COVID-19. Variations in performance between quarters can be expected to continue.
The Company is unable to provide guidance on a Reported basis because AstraZeneca cannot reliably forecast
material elements of the Reported result, including any fair value adjustments arising on acquisition-related
liabilities, intangible asset impairment charges and legal-settlement provisions. Please refer to the cautionary
statements section regarding forward-looking statements at the end of this announcement.
Currency impact
If foreign-exchange rates for October to December 2021 were to remain at the average of rates seen in the year
to date, it is anticipated that there would be a low single-digit favourable impact on Total Revenue and an
immaterial impact on Core EPS versus CER data. The Company’s foreign-exchange rate sensitivity analysis is
contained within the operating and financial review.
Financial summary
- Variances across periods are based on a comparison of the Group’s performance in the year to date and
the quarter, including Alexion from 21 July 2021, with the Group’s performance in the comparative prior
periods, which do not include Alexion. Pro forma total revenue growth rates have been presented only for
Q3 2021 Rare Disease and its constituent medicines, and do not impact any Group totals
- Total Revenue, comprising Product Sales and Collaboration Revenue, increased by 32% in the year to date
(28% at CER) to $25,406m. Total Revenue included $2,219m from the pandemic COVID-19 vaccine
- Reported Gross Profit14 Margin in the year to date declined eleven percentage points to 68.8%; Core Gross
Profit Margin declined six percentage points in the year to date to 74.1%, predominantly reflecting the
equitable supply, at no profit to AstraZeneca, of the pandemic COVID-19 vaccine, together with an increasing
impact from profit-sharing arrangements (primarily Lynparza and roxadustat) and the impact of the NRDL
and VBP programmes in China. These effects were partially offset by the contribution of Alexion from
21 July 2021, a higher proportion of Oncology sales, and increasing patient access in China. Reported Gross
Profit Margin was also impacted by $1,044m due to the unwind of the fair value adjustment to Alexion
inventories at the date of acquisition. Variations in gross margin performance between periods can be
expected to continue
- Reported Total Operating Expense increased in the year to date by 39% (34% at CER) to $17,591m. Core
Total Operating Expense increased by 24% (20% at CER) to $13,649m and represented 54% of Total
Revenue (YTD 2020: 57%)
- Reported R&D Expense increased in the year to date by 67% (63% at CER) to $7,152m including an
impairment charge of $1,172m recognised in the quarter on an intangible asset related to the acquisition of
Ardea Biosciences, Inc. in 2012, following the decision to discontinue the development of verinurad. Core
R&D Expense increased in the year to date by 34% (30% at CER) to $5,591m with increases in both
Reported and Core R&D Expense reflecting the Company's continued investment in its COVID-19 vaccine
and AZD7442, investment in several late-stage Oncology trials and the advancement of a number of Phase II
clinical development programmes in BioPharmaceuticals
- Reported SG&A Expense increased in the year to date by 25% (21% at CER) to $10,117m and includes the
increased amortisation of intangible assets related to the Alexion acquisition. Core SG&A Expense increased
by 19% (14% at CER) to $7,736m, reflecting the addition of Alexion SG&A expenses from 21 July 2021,
investment in Oncology-medicine launches, the launch of several new BioPharmaceuticals medicines,
particularly in the US, AstraZeneca's further expansion in Emerging Markets, and the existing infrastructure
base in China
- Reported and Core Other Operating Income and Expense
increased in the year to date by 51% (50% at
CER) to $1,345m and $1,346m respectively, and included $776m income from the divestment of
AstraZeneca's 26.7% share of Viela Bio, Inc. (Viela) in March 2021
- The Reported Operating Profit Margin declined fourteen percentage points (thirteen at CER) to 5.3%,
reflecting the aforementioned intangible impairments and other factors. The Core Operating Profit Margin
declined two percentage points (one percentage point at CER) in the year to date to 26.0% driven by the
aforementioned increase in R&D and SG&A expenses
- Reported EPS in the year to date declined 80% (65% at CER) to $0.33. Core EPS increased by 22% (23%
at CER) to $3.59. Reported and Core EPS were adversely affected by $0.03 due to the pandemic COVID-19
Table 2: Select Medicines Total Revenue performance
Further details of the individual medicine performances are provided in the Total Revenue section.
YTD 2021 Q3 2021
Actual CER Actual CER
$m % change % change $m % change % change
Tagrisso Oncology 3,701 17 13 1,247 8 7
Imfinzi 1,778 20 17 618 16 15
Lynparza 1,719 21 18 588 27 25
Calquence 843 n/m n/m 354 n/m n/m
Enhertu 147 n/m n/m 57 n/m n/m
Farxiga CVRM 2,156 57 51 797 51 48
Brilinta 1,124 (9) (11) 375 (3) (4)
Bydureon 293 (10) (11) 95 (13) (13)
roxadustat 148 n/m n/m 56 n/m n/m
Lokelma 122 n/m n/m 49 n/m n/m
Symbicort R&I 2,047 - (3) 676 13 11
Fasenra 901 35 32 322 34 33
Pulmicort 714 14 7 217 44 36
Breztri 130 n/m n/m 47 n/m n/m
Soliris16 Rare 798 n/m n/m 798 (3) (2)
Ultomiris16 Disease16 297 n/m n/m 297 31 31
Strensiq16 159 n/m n/m 159 7 8
COVID-19 vaccine COVID-19 2,219 n/m n/m 1,050 n/m n/m
Table 3: Regional Total Revenue performance
Further details of the regional performances are provided in the Regional Total Revenue section.
YTD 2021 Q3 2021
% of Actual % CER % Actual % CER %
$m total change change $m change change
Emerging Markets 8,618 34 33 28 3,159 48 42
US 8,305 33 29 29 3,471 53 53
Europe 5,178 20 40 31 1,918 52 49
Established RoW 3,305 13 28 24 1,318 45 46
Total 25,406 100 32 28 9,866 50 48
Total Revenue from Emerging Markets increased 33% (28% CER) to $8,618m, of which $1,139m came from
the pandemic COVID-19 vaccine. Excluding the COVID-19 vaccine, Total Revenue from Emerging Markets
increased by 16% (10% at CER) in the year to date to $7,479m.
Corporate and business development
In 2019, Caelum Biosciences (Caelum) and Alexion entered into a collaboration to develop CAEL-101 for light
chain amyloidosis, whereby Alexion acquired a minority equity interest and an exclusive option to acquire the
remaining equity in Caelum. AstraZeneca has treated Caelum as a subsidiary from the date of acquisition of
Alexion, reflecting a non-controlling interest of $150m. On 5 October 2021, the Group completed the acquisition
of the remaining shares of Caelum and paid its shareholders the option exercise price of $150m, with the potential for additional payments of up to $350m upon achievement of regulatory and commercial milestones.
In November 2021, AstraZeneca agreed to transfer its global rights to Eklira, known as Tudorza in the US, and Duaklir to Covis Pharma Group for $270m payable on completion, which is expected in the fourth quarter of
2021. Covis Pharma Group will also cover certain ongoing development costs related to the medicines. The income arising from the upfront payment will be fully offset by a charge for derecognition of the associated
intangible asset and therefore no Other Operating Income will be recognised in AstraZeneca’s financial statements.

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