Glossary

Alfentanil
A potent synthetic opioid analgesic drug, used for anaesthesia in surgery

American Depositary Receipt (ADR)
An instrument that is issued by a depositary bank that represents ownership of a company’s underlying shares. ADR programs are created to facilitate US investors to hold shares in non-US companies and trade them in the same way as US securities.

Anaesthesia
Procedure for lowering a patient’s consciousness to enable a medical procedure to proceed without pain for the patient

ANDA
An Abbreviated New Drug Application (ANDA) is an application for a US generic drug approval for an existing licensed medication or approved drug

Breakthrough pain
A short, intensive period of pain that occurs in addition to chronic levels of long-term pain even though these are treated by regular painkillers

Buprenorphine
A potent opioid partial agonist first used as a pain-elieving substance, but now most commonly used to help patients withdraw from more addictive opioid drugs such as morphine

CARA
The Comprehensive Addiction and Recovery Act (CARA) became law in the US in July 2016. CARA authorizes a series of grants aimed at among other things developing treatment programs which further expands buprenorphine prescribing rights to nurse practitioners and physician assistants

Cash & vouchers segment
One of the three distinct payer segments in the market for treat- ment of opioid dependence. In this segment, the patient is paying for the prescriptions out of pocket

CLI
Cysteinyl Leukotriene Inhibitor

Clinical studies/Clinical trials
Studies of the safety and efficacy of a drug in human beings

Commercial segment
One of the three distinct payer segments in the market for treat- ment of opioid dependence. The commercial segment is funded by private insurances or employers

Drug delivery
The process through which a pharmaceutical may be introduced to the patient that enables the active compound to function as intended

EMA
The European Medicine Agency

FDA
The US Food and Drug Administration

Fentanyl
An opioid with a similar effect on human patients as morphine. Used mainly within anasthesia and analgesia

GMP
Good Manufacturing Practice

HHS
The US Department of Health and Human Services

IP
Intellectual Properties

Naloxone
An opioid inverse agonist used to counter the effects of opioids

NCE
New Chemical Entity

Opioids
Collective term for compounds that act via opioid receptors on nerve cells, mainly in the central nervous system

PBM (Pharmacy Benefit Manager)
Responsible for management of costs associated with prescription pharmaceuticals and recommendations on behalf of insurance companies and employers in the US

PGE
Prostaglandin (PG) E2 – biologically active mediator derived from arachidonic acid and involved in inflammatory conditions

Phase I studies
Studies mainly of the safety of a drug. Performed on healthy human volunteers

Phase II studies
Studies of the safety and efficacy of a drug in appropriate doses. Performed on a limited number of patients

Phase III studies
Studies of the safety and efficacy of a drug in a clinical setting. Performed on a large number of patients

Preclinical development/Preclinical studies
Studies of the safety and efficacy of a drug prior to evaluation in humans. Can be performed on animals and in various cell systems

Public segment
One of three distinct payer segments in the market for treatment of opioid dependence. The public segment covers state and federal funded reimbursement programs i.e. Managed Medicaid, FFS Med- icaid, Medicare Part D

REZOLV
The REZOLV (Retrospective Evaluation of Zubsolv Outcomes – A Longitudinal View) study is a medical record review conducted to examine and characterize the impact of treatment and psychosocial factors on the early outcomes of patients who utilized Zubsolv® therapy for opioid dependence. The data was collected from 1,080 patients being treated by 134 physicians across 87 US treatment sites of which 80 were private practices and 7 were institutional sites.

Sublingual
Under the tongue

Zolpidem
A pharmaceutical substance used to treat temporary or short-term insomnia

 

Definitions & Key Figures

Key figures and certain other operating information per share are deined as follows:

 

Capital employed Interest-bearing liabilities and shareholders’ equity
Debt/equity ratio Interest-bearing liabilities divided by shareholders’ equity
EBIT

Earnings before net financial items and tax, the same as Operating earnings
EBITDA Earnings before interest, taxes, depreciation and amortization. EBIT plus depreciation
Earnings per share, before dilution Net earnings for the period after tax divided by the weighted average number of shares outstanding after dilution during the period
Equity/assets ratio Shareholders’ equity as a percentage of total assets
Gross Revenues

Grand total of all invoiced sales transactions reported in a period, without any deductions
Gross to net ratio Net Revenues divided by Gross Revenues
Investments Value of an investment before depreciation
Net debt Current and long-term interest-bearing liabilities including pension liabilities, less cash and cash equivalents
Net earnings PeriOperating Earnings plus Net Financial Items plus tax
Net financial items Financial revenue minus financial cost
Net Revenues Gross Revenues less deductions for sales rebates, sales allowances, distribution, sales returns and other relevant deductions
Number of shares after dilution Shares at the end of the period adjusted for the dilutive effect of potential shares
Operating expenses A non-capital expense incurred in daily operating activities
Operating margin Operating earnings as a percentage of net revenues

Return on shareholders’ equity

 Net earnings for the period as a percentage of average shareholders’ equity
Working capital Current assets less current liabilities
 Zubsolv net revenue Revenue net of discounts and returns