Medela

Welcome to Medela (Urs Tanner – Del. des VR)
The world’s leading manufacturer of breastfeeding
and medical vacuum solutions
Supporting health through the life
giving benefits of breastfeeding
Precious life, progressive care, through innovative
healthcare solutions
© Medela
Breastfeeding & Healthcare revenue divide
Mio CHF
10%
Healthcare
Breastfeeding
90%
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Our company at one glance
• A family business since 1961 and in the US since 1979.
Challenges often have three letters (FDA, FTC, DOJ, EPA,
IRS, ACA etc.)
• More than 1550 employees
• Operations in 15 countries, sales in 90 + countries
• Sales 2013: approx. CHF: 500 Mio
• Headquarters in Baar, Switzerland
© Medela
Medela today
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Diverse geographical spread - 2013
USA 54%
International Sales 9%
Germany 10%
Switzerland 2%
Benelux 3%
Italy 2%
United Kingdom 2%
France 3%
Sweden 2%
Japan 1%
Spain 2%
Canada 4%
Russia 2%
Australia 1%
China 1%
Poland 0%
Total Revenue 2013: 500 Mio. CHF
Total Revenue 2010: 360 Mio. CHF
© Medela
Medela Breastfeeding Group
Supporting precious life
“
Medela‘s breastfeeding
group exists to enhance
mother and baby health
through the life-giving
benefits of breastmilk
„
© Medela
A leading choice for hospitals and mothers
02.07.2013
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7
Medela Breastfeeding Business Model
Our Goal - Professional Technology for all Mothers
Hospitals
Rental
Hospital
Medical & Juvenile
RentalRetail
Babyshop Chains
Juvenile & Medical Retail
General Mass
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Technology
Transfer
Advanced breastfeeding research – driving all that we do
Breast Anatomy &
Milk Production
Infant Sucking &
Breastmilk Feeding
Breastfeeding
(Basic research)
Breastpumping
(Applied research)
02.07.2013
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9
CH-KMU in USA: lessons learned für Medtech Firmen
Marktzugang:
=> If a product takes off, the Medela group receives a new block
buster.
=> FDA Approval – the US is a highly regulated market.
Compliance is essential. Medela is under a warning letter and
has the FDA as a visitor ever so often.
Reimbursement: recently yes and landscape changes fast.
=> ACA (Affordable Care Act)
© Medela
CH-KMU in USA: lessons learned für Medtech Firmen
Arbeitsrecht: wichtige Empfehlung
⇒ employment at will in combination with a qualified and quantified
separation policy
⇒ if a contract, pay attention to Term & Termination: without cause,
for cause or for good cause).
© Medela
CH-KMU in USA: lessons learned für Medtech Firmen
Rekrutierung und Führung von MA / Kulturelles
⇒ KSF; we give business to the locals
⇒ The US is substantially different. Fail fast – learn fast – fix fast!
⇒ Have a dream = a sense of purpose and a sense of belonging.
⇒ Participation - inspiration - interaction - return on involvement and
creating a movement! Creativity - responsibility - learning recognition and joy.
“Winning is not everything, wanting to win is” (Vince Lombardi sports coach)
© Medela
CH-KMU in USA: lessons learned für Medtech Firmen
FTC:
=> when you have achieved a dominat market position you should
expect the FTC to knock on your door!
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IRS: Taken by surprise?!
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Grundproblematik Transferpreise (2)
Grenzüberschreitende Geschäftsbeziehungen zwischen
verbundenen Unternehmen müssen „at-arm‘s-length“ausgeführt
werden, d.h. Gruppen-Gesellschaften müssen sich konzernintern
so verhalten, wie sich zwei unabhängige Dritte verhalten hätten.
Rechtliche Grundlagen:
– Art. 9 Abs. 1 des OECD-Musterabkommens
– Verrechnungspreisrichtlinien der OECD
– Nationale Verrechnungspreisbestimmungen
– Doppelbesteuerungsabkommen
– Nationale Steuergesetze
Mögliche Rechtsfolgen bei Nicht - Compliance:
– Steuerliche Aufrechnungen
– Wirtschaftliche Doppelbesteuerung
– Bussen
– Annexsteuern (Quellensteuern, Zollwerte)
– Persönliche Restriktionen (insbesondere für Tax Directors, CFOs und GF‘s)
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Massnahmen zur Risikominimierung
• Klare und transparente Transferpreis-Politik
• Konsistentes Transferpreis-Konzept => wählen der
best-möglichen Methode
• Klare und vollständige Dokumentation => have your
TP-study ready and up to date!
• Verträge => Leben der vertraglich vereinbarten
Strukturen
• Zentrales Management von Transferpreisfragen
• Laufende Anpassung an Veränderungen ist
zwingend (Restrukturierungen, Fusion, Änderungen
des regulatorischen Umfeldes, etc.)
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CH-KMU in USA: lessons learned für Medtech Firmen
Produktehaftpflicht and legal environment:
⇒ The US is a law suit happy market. 1995 - 2013 Medela had
substantial legal costs and gained expertise on District Court,
Federal Circuit and Supreme Court level.
⇒ Settle of fight? Align goals and check statistics. Make sure you
truly understand the game!
⇒ http://halcyonassociates.com/ => if in a law suit, please call.
We’ll save you considerable monies, time and emontions!
⇒
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© Medela
CEO’s Guide to US Lawsuits
Harvard AMP, May 15, 2013
Carr Lane Quackenbush (Former US President of Medela
Inc.)
Urs Tanner (Former Global CEO of Medela Holding AG)
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Get the facts
to understand the situation
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Judge’s record of fairness
• Outcome of the case depends more on the Judge
than on the facts.
• US judicial system is biased against Defendants.
• Over 80% of US Federal cases are settled, 96% in
some jurisdictions, 98% with some judges!
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Get the facts
to understand the situation
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•
Plaintiff or Plaintiff’s Lawyer – who’s in control?
•
•
Whoever pays the legal bills controls the lawsuit; only their goals
and motivations count.
Other clues - Who does the talking? (Make sure you negotiate
with the party in control!)
• If Plaintiff – lawsuit will be a “legitimate” argument
about facts
• If Plaintiff’s Lawyer – lawsuit will be a pretext to win
settlement money.
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Thank you
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Back up slides – je nach Diskussion
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The most important thing you will
learn in this lecture:
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Start by analyzing and understanding
the actual roles and motivation of all
key players in a lawsuit suit (Plaintiff,
Plaintiff’s Lawyer, Judge)
• Understand the true situation - from this, set lawsuit goals &
strategy then legal tactics to achieve goals & strategy.
• Management must lead. Do not abdicate management of your
lawsuit to Outside Counsel.
•
Remember they are paid by the hour; their compensation does not
match your goals
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The process –
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Your lawsuit is a business problem…
1.
Get the facts (quantitative as possible) to understand the
situation,
•
•
2.
3.
Plaintiff or Plaintiff’s Lawyer – who’s in control?
Judge’s record of fairness
Evaluate options, then
Set your lawsuit goals and strategy; from this establish tactics
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US Jury Trial
MOTION to DISMISS
(MTD)
MOTION for SUMMARY
JUDGMENT (MSJ)
OUT
Yes
OUT
No
MTD
Prep
Yes
TRIAL
OUT
DISCOVERY
(documents)
DEPOSITIONS
(people)
MSJ
prep
No
Win
TRIAL
prep
Lose
DAMAGES
SETTLEMENT (any time)
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Your goals & decisions
• Assumed lawsuit goals = get out with minimum cost, time and
management distraction.
• Unanswered question = whether to fight for “justice”.
•
Depends on cost and probability of achieving “justice”
your Judge’s bias.
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depends on
Transfer Price Methods Chosen
• tangible products:
•
RPM (resale price method, checks gross margins) and TNMM
(transactional net margin method, checks operating margins).
• intangible products:
•
CUT (comparable uncontrolled transaction)
• interest / management services:
•
cost+
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Vertrag MINC
MAG
Transfer Pricing:
=> TP study should be in place
Royalties and TP => at arms length
Management Fees => at fair market value
© Medela
© by
Medela