Glossary

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.

ANDA

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

Anesthesia

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

Artificial intelligence

Artificial intelligence (AI) is the simulation of human intelligence processes by machines, especially computer systems

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

Broca®

GAIA's proprietary intelligence system, based on artificial intelligence, underpins the development of digital therapies targeting multiple therapy areas

Buprenorphine

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

Cash segment

One of the three distinct payer segments in the US market for treatment of opioid dependence. In this segment, the patient is paying for the prescriptions out of pocket

CHMP

The Committee for Medicinal Products for Human Use

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 US market for treatment of opioid dependence. The commercial segment is funded by private insurances or employers

Digital therapeutics (DTx)

Digital therapeutics, a subset of digital health, are evidence- based therapeutic interventions driven by high quality software programs to prevent, manage, or treat a medical disorder or disease

Digital health

Digital health is the convergence of digital technologies with health and healthcare to enhance the efficiency of healthcare delivery and make medicine more personalized and precise

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 anesthesia and analgesia

HHS

The US Department of Health and Human Services

In Vitro studies

In an in vitro study; living matter is examined outside of its natural context e.g. in a test-tube

IP

Intellectual Properties

Naloxone

An opioid antagonist used to counter the effects of opioids

LTM

Last Twelve Months

NSAID

Non-steroid anti-inflammatory drugs which are active against pain, inflammation and fever

NTRx

Tablets per prescription divided by 30

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

Proof of Concept studies

A Proof of Concept study is performed to get a first indication of an idea’s practical feasibility

Public segment

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

Reimbursement

Contribution from the state or insurance company in order to reduce the price of drugs / treatment for the patient

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