Interim Report of BB Biotech AG as of March 31, 2016
22 Abril 2016 - 6:51AM
Italian Regulatory (Text)
Media release as of April 22, 2016
Interim Report of BB Biotech AG as of March 31, 2016
Challenging first quarter for biotech investments
Major regulatory approvals and significant clinical read-outs for
portfolio companies pending After a long and steady advance, the
biotech sector experienced a steep correction of nearly 23% in the
first quarter of 2016 (NBI in USD). Profit-taking and the debate
among US presidential candidates over drug prices were the primary
triggers for this short-term downturn. BB Biotech shares also
retreated, by 16.5% in CHF, 17.4% in EUR and 13.0% in USD (incl.
the dividend pay-out), which was far less than the benchmark index.
The shares' discount to Net Asset Value therefore virtually
vanished. BB Biotech reports a net loss of CHF 1.2 bn for the first
quarter of 2016 compared to a net profit of CHF 379 mn for the same
period last year. Although biotech stocks did not gain on news
reports of product approvals and successful clinical outcomes in
the first quarter, the outlook remains positive. BB Biotech views
the current correction as a temporary move and is maintaining its
positioning. At the Annual General Meeting on March 17, 2016, the
Board of Directors reiterated its intention to pay out a dividend
equivalent to a 5% yield. 2016 started off with a significant
equity market correction. With equity indices stabilizing and
recovering some of the substantial losses, the first quarter total
return for the S&P 500 index was flat in USD, down 7.2% in EUR
for the DAX and down 10.2% in CHF for the SMI. Following several
years of significant outperformance against the broad equity
indices, the biotech sector valuations fell in association with
profit-taking fueled by US presidential election campaigns
promising hardly realizable moves on drug pricing. The NBI fell
22.9% in USD in Q1 2016, one of the most significant quarterly
declines in history of the biotech equity markets. BB Biotech's
performance for the first quarter of 2016 BB Biotech weathered this
storm by focusing on high quality investments and a long term view.
The total return for BB Biotech's share was better than the sector
indices by around 10% and also ahead of the portfolio.
Nevertheless, BB Biotech's shares declined 16.5% in CHF, 17.4% in
EUR and 13.0% in USD, including the dividend payment. The
difference between share price and the Net Asset Value which was
18% at the end of 2015 reduced to almost zero with the share
price trading close to the book value of the assets. The portfolio
showed an overall loss of 30.1% in CHF, 30.5% in EUR and 27.1% in
USD. Proportionally greater exposure to smaller and mid cap
holdings, with the leverage maintained throughout the market
correction, and the depreciation of the US dollar to the Euro and
the Swiss Franc all resulted in a significant temporary drop in the
value of the net assets of BB Biotech. For Q1 2016, BB Biotech's
net loss amounts to CHF 1.2 bn, compared to a net profit of CHF 379
mn for the same period in 2015. Total return calculations include
the dividend distribution of CHF 14.50 per share in accordance with
BB Biotech's proposed dividend policy and as approved by
shareholders at this year's AGM on March 17, 2016. The distribution
is another substantive increase compared to the dividend of last
year, driven by the share price appreciation of 2015. Continued
distribution and a five-for-one share split BB Biotech paid its
proposed dividend of CHF 14.50 per share, expending the remaining
paid-in capital reserves by distributing CHF 12.25 per share, plus
a regular cash dividend of CHF 2.25 per share. The board announced
it will continue the current distribution policy in the future,
paying a regular dividend calculated at 5% of the average December
share price. The share repurchase program ongoing throughout 2015
and the first quarter of 2016 reached was closed prior to the AGM
having acquired 770 000 shares (before split) of BB Biotech through
the second trading line. The AGM
approved the cancellation of these shares. Additionally, BB Biotech
implemented a five-for-one share split on March 29, 2016. The total
number of shares outstanding post the split is 59 250 000, or 55
400 000 after the deletion of the shares repurchased through the
second trading line which is planned earliest in the second quarter
of 2016. A new share-repurchase program of a maximum of 10% of the
outstanding shares, or 5 540 000 shares, was approved at the AGM
and is required to close within a 36-months window. In combination
with the dividend payout, this enables the continuation of the
structured distribution policy to return capital to shareholders,
providing them with up to 10% annual return. First quarter
portfolio activity Despite economic challenges and substantially
increased volatility in the biotech equity markets, BB Biotech
maintained most of its portfolio positions. The holdings in Swedish
Orphan Biovitrum and Actelion were marginally reduced. In contrast,
taking advantage of lower share prices, BB Biotech increased
holdings in selected US smaller and mid cap companies such as
Ionis, Incyte, Radius, Halozyme, Alnylam, Cempra, Sage, Esperion
and Prothena. The team also increased the holding in Cidara,
initiated in the fourth quarter 2015, throughout the first quarter
2016 and sold all of the remaining shares in the Tetraphase
position following their failed Phase III study for Eravacyline. At
the beginning of 2016, BB Biotech's investment leverage was CHF
140.5 mn, or 3.5% of the net assets. On March 31, 2016, the
leverage had increased to CHF 332.5 mn, or 12.8% of the net assets.
The increase was attributed to the dividend pay-out of CHF 160 mn
and the increase of BB Biotech's portfolio exposure to smaller and
mid cap biotech companies. Asymmetrical market reactions offer
opportunity for future performance The biotech industry's continued
progress is dependent on successful innovation, demonstrated by
positive late stage clinical trials and ultimately new product
approval status and successful commercialization. Unlike prior
years, biotech equity markets showed muted responses to company
announcements of progress during the first quarter of 2016. BB
Biotech anticipates this sentiment to be temporary and continues to
believe that developments and launch of innovative medicines will
drive share price appreciation among our holdings. Gilead achieved
regulatory approvals for its TAF-containing HIV single tablets. TAF
is Gilead's next generation Viread (Tenofovir) maintaining Viread's
strong efficacy profile but with an improved side effect profile
with TAF having less impact on the patient's bones and kidneys. TAF
is the backbone product for Gilead to maintain leadership in the
HIV market and to overcome the loss of exclusivity for Viread in
the coming years. In March, the US FDA approved Odefsey, a
fixed-dose combination containing Emtricitabine, Rilpivirine and
TAF. In Europe, the CHMP adopted a positive opinion for Descovy, a
fixed-dosed combination of Emtricitabine and TAF. Actelion received
a positive CHMP opinion for Selexipag in January 2016. Due to
procedural changes, the EMA re-confirmed its positive
recommendation once again in late March. BB Biotech now expects
European launch during the second quarter of 2016. Novo Nordisk
shares fell in value when management updated its long-term
financial goals for top line growth from mid-teens down to the 10%.
The company regained some of the lost ground following announcement
of two positive results from two important clinical studies. The
LEADER study of Victoza in more than 9000 adult type 2 diabetic
patients showed a reduction of cardiovascular death, non-fatal
myocardiac infarction and non-fatal stroke for Victoza in
combination with standard of care. The SWITCH study showed that
Tresiba is superior to Sanofi's Lantus for avoidance of
hypoglycemia, both for symptomatic and nocturnal events. Both
SWITCH and LEADER are expected to support further growth for Novo
Nordisk's leading diabetes franchise for years to come. Alder, a
newer holding of BB Biotech focusing on CNS-related disorders, also
reported positive clinical trial data. Alder reported two positive
Phase II migraine prevention trials for ALD403, an anti-CGRP
antibody. In addition to these data, Alder announced successful
outcomes for the subcutaneous formulation of its CGRP antibody,
opening the door for them to pursue development of a
self-administered medication.
Markets were on the other hand surprised by the "refuse to file"
letter issued by the FDA for PTC's Ataluren. Consequently, PTC's
share price fell more than 80% in the first quarter of 2016. PTC
has stated that they expect shortly a final European regulatory
decision on Ataluren, in which it currently sells in some European
countries based on a conditional approval. In summary, large cap
biotech share prices corrected by 10-20%, mid caps by 20-40% and a
range of small caps fell by 40-50% during the first three months of
2016, often despite progress with their research programs. In BB
Biotech's view, the important milestones achieved have not
generally been factored into company valuations yet. The team
believes that these positive events presage upside as the biotech
market recovers its poise. Outlook BB Biotech anticipates 2016 to
remain volatile for biotechnology equities. Nevertheless, product
approvals and read-outs rate from key clinical trials are expected
to accelerate throughout the remainder of the year and offer the
potential for significant growth in share price valuations.
Important regulatory milestones anticipated for companies in BB
Biotech's portfolio include: Intercept obeticholic acid (OCA) for
treating primary biliary cirrhosis Gilead fix dose combination of
Sofosbuvir/Velpatasvir for treating all genotypes of chronic
hepatitis C viral infections Neurocrine Valbenazine for treating
patients suffering from tardive dyskinesia Radius
Abaloparatide-SC for the treatment of postmenopausal women with
osteoporosis Medivation label expansion for Xtandi for prostate
cancer
Many important clinical trial results are also expected to impact
company share prices, including: Tesaro Niraparib, a PARP
inhibitor for treating ovarian cancer patients and Clovis
Rucaparib, another PARP inhibitor for treating ovarian cancer
patients Vertex VX-661/ivacaftor combination for treating cystic
fibrosis patients that are heterozygous for the F508 deletion
Incyte Epacadostat in multiple Phase II studies in combination
with various PD1 antibodies for treating non-small cell lung cancer
patients Celgene Revlimid tested in the REMARC study for patients
with diffuse large B-cell lymphoma Novavax RSV vaccine Phase III
data for elderly persons
Many more milestones are anticipated in 2016 and these are expected
to support the strong fundamentals of the portfolio and the
biotechnology sector. With large pharmaceutical companies declaring
their interest in M&A we may see increased consolidation with
opportunities for favorable exit valuations for some biotech firms.
In BB Biotech's view, such take-over activity, while inherent
unpredictable in timing and targets, is likely to impact the
biotech markets the most in the short term. The portfolio continues
to focus on innovations leading to effective and efficient
treatment options. For further information: Investor Relations
Bellevue Asset Management AG, Seestrasse 16, 8700 Küsnacht,
Switzerland, tel. +41 44 267 67 00 Dr. Silvia Schanz,
ssc@bellevue.ch Maria-Grazia Iten-Alderuccio, mga@bellevue.ch
Claude Mikkelsen, cmi@bellevue.ch Media Relations Bellevue Asset
Management AG, Seestrasse 16, 8700 Küsnacht, Switzerland, tel. +41
44 267 67 00 Tanja Chicherio, tch@bellevue.ch b-public AG,
Pfingstweidstrasse 6, 8005 Zürich, Switzerland, tel. +41 79 423 22
28 Thomas Egger, teg@b-public.ch www.bbbiotech.com
Company profile BB Biotech invests in companies in the fast growing
market of biotechnology and is one of the world's largest investors
in this sector. BB Biotech is listed in Switzerland, Germany and
Italy. Its investments are focused on listed companies that are
developing and commercializing novel medical treatments and cures.
BB Biotech's investment selection process is guided by the
fundamental research and analysis of physicians and molecular
biologists. Its Board of Directors has many years of experience in
industry and science. Disclaimer This release contains
forward-looking statements and expectations as well as assessments,
beliefs and assumptions. Such statements are based on the current
expectations of BB Biotech, its directors and officers, and are,
therefore, subject to risks and uncertainties that may change over
time. As actual developments may significantly differ, BB Biotech
and its directors and officers accept no responsibility in that
regard. All forwardlooking statements included in this release are
made only as of the date of this release and BB Biotech and its
directors and officers assume no obligation to update any
forward-looking statements as a result of new information, future
events or other factors.
Composition of BB Biotech's portfolio as of March 31, 2016
(in % of securities, rounded values)
Celgene Actelion Incyte Ionis Pharmaceuticals Gilead Alexion
Pharmaceuticals Radius Health Neurocrine Biosciences Medivation
Novo Nordisk Vertex Pharmaceuticals Agios Pharmaceuticals Alnylam
Pharmaceuticals Regeneron Pharmaceuticals Swedish Orphan Biovitrum
Halozyme Therapeutics Tesaro Juno Therapeutics Novavax Alder
Biopharmaceuticals Cempra Kite Pharma Intercept Pharmaceuticals
Probiodrug Sage Therapeutics Esperion Therapeutics Prothena Corp.
Infinity Pharmaceuticals Puma Biotechnology Clovis Oncology
Achillion Pharmaceuticals Cidara Therapeutics PTC Therapeutics
Radius Health warrants 04/23/2018 Radius Health warrants 02/19/2019
Merck & Co Inc Contingent Value Rights ex Trius/Cubist Total
securities Other assets Other payables Total shareholders' equity
1) Treasury shares (in % of company)
11.9% 10.1% 9.1% 9.0% 8.4% 4.7% 4.5% 4.1% 3.9% 3.9% 3.6% 2.9% 2.5%
2.4% 2.4% 2.3% 1.8% 1.6% 1.4% 1.2% 1.2% 1.1% 1.1% 0.9% 0.9% 0.6%
0.5% 0.5% 0.4% 0.3% 0.3% 0.3% 0.3% 0.1% 0.1% 0.0% CHF 2 930.5 mn
CHF 22.0 mn CHF (354.5) mn CHF 2 597.9 mn 6.5%
1) Corresponds to the total of all own shares held including the
second trading line
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