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 |