Glossary & Defintions



Abbreviated New Drug Application, ANDA

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

American Depositary Receipt, ADR

An instrument that is issued by a depositary bank that represents own- ership 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

Artificial intelligence, AI

Artificial intelligence (AI) is the simulation of human intelligence pro- cesses 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


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


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 payer segment

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

Clinical studies/ Clinical trials

Studies of the safety and efficacy of a drug in human beings

Cognitive behavioral therapy techniques, CBT

Cognitive behavioral therapy techniques, CBT are used to alter mal- adaptive thought patterns. The cognitive behavioral therapy is used in the treatment of various disorders related to mood, personality, anxiety, substance abuse, etc.

Commercial payer segment

One of three payer segments in the US market for treatment of opioid dependence. The commercial segment is funded by private insurances or employers

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

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

Drug delivery

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

Food and Drug Administration, FDA

The United States Food and Drug Administration is a federal agency
of the Department of Health and Human Services, HHS. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, pharmaceu- ticals and other medicinal products

Investigational New Drug, IND

The FDA’s Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials before a marketing application for the drug has been approved


Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID) used to treat moderate to severe pain.

Medication assisted treatment, MAT

Medication assisted treatment (MAT) is the use of medications, in combination with counseling and behavioral therapies, to provide a “whole-patient” approach to the treatment of substance use disorders


An opioid antagonist used to counter the effects of opioids

New Drug Application, NDA

The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the US

Non-steroidal anti-inflammatory drugs, NSAIDs

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

Open market

ZUBSOLV’s total business where the pharmaceutical is reimbursed and competes with other products in the market both branded and/or generics. Open formulary business excludes recent formulary changes in United Health Group and Humana, the cash payer segment, and payers where it is not reimbursed


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

Pharmacokinetic study, PK study

A clinical study investigating the absorption, distribution, metabolism and elimination of a drug by the body. Pharmacokinetics (PK) is the study of how an organism affects a drug, whereas pharmacodynamics (PD) is the study of how the drug affects the organism. Both together influence dosing, benefit, and adverse effects, as seen in PK/PD models.

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 payer segment

One of three 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

Randomized controlled trial, RCT

A randomized controlled trial, RCT is a clinical trial aims to reduce certain sources of bias when testing the effectiveness of new treat- ments; this is accomplished by randomly allocating subjects, treating them differently, and then comparing them with respect to a meas- ured response


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

Rest of World, RoW

Rest of World, RoW refers to countries or territories other than United States (US) and European countries (EU)


Under the tongue


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

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