Glossary
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
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 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
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
Naloxone
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
Opioids
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
Reimbursement
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)
Sublingual
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 |
| 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 |