Glossary
ANDA
An Abbreviated New Drug Application (ANDA) is an application for a US generic drug approval for an existing licensed medication or approved drug.
ADR
An American Depositary Receipt (ADR) is 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.
BSC
Background Study Care (BSC) is the general care that a patient can receive alongside the care being tested in a clinical trial. In the MODIA® study this included weekly medication management.
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 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
Studies of the safety and efficacy of a drug in human beings.
CBT
Cognitive behavioral therapy techniques (CBT) are used to alter maladaptive thought patterns. The cognitive behavioral therapy is used in the treatment of various disorders related to mood, personality, anxiety, substance abuse, etc.
Commercial 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.
CMO
Abbreviation of Contract Manufacturing Organisation
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.
DTx
Digital therapeutics (DTx), 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.
Epinephrine
A hormone used in emergency treatments of allergic reactions.
EUA
An Emergency Use Authorization (EUA) is an authorization granted by the FDA to allow the use of a drug prior to approval.
FDA
The United States Food and Drug Administration (FDA) 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, pharmaceuticals and other medicinal products.
HCP
Healthcare providers (HCP), the healthcare professionals responsible for care.
IP
Abbreviation of Intellectual Properties.
Large molecules
New biological entities commonly created by the polymerization of smaller subunits such as protein.
MAT
Medication Assisted Treatment (MAT) is the use of medications, in combination with counseling and behavioral therapies, to provide a holstic approach to the treatment of substance use disorders.
Nalmefene
An opioid antagonist used to counter the effects of opioids.
Naloxone
An opioid antagonist used to counter the effects of opioids.
NDA
The New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that the FDA approves a new pharmaceutical for sale and marketing in the US.
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 branded and/or generic products in the market. 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.
OUD
Abbreviation of Opioid Use Disorder. When someone is suffering from OUD they have a persistent desire or unsuccessful efforts to cut down or control opioid use. A great deal of time is spent in activities necessary to obtain the opioid, use the opioid, or recover from its effects. Craving, or a strong desire or urge to use opioids.
Preclinical studies
Abbreviation of Prescription Drug User Fee Act. A PDUFA-date is the deadline for the FDA to review a new drug.
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 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 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.
RCT
A randomized controlled trial (RCT) is a clinical trial that aims to reduce certain sources of bias when testing the effectiveness of new treatments. This is accomplished by randomly allocating subjects, treating them differently, and then comparing them with respect to a measured response.
Reimbursement
Contribution from the state or insurance company in order to reduce the price of drugs / treatment for the patient.
RoW
Rest of World (RoW) refers to countries or territories other than United States (US) and European countries (EU).
RWE
Real-World Evidence (RWE) is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of Real-World Data (RWD); data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources outside of a clinical trial setting.
Small molecules
Low molecular weight organic compounds, typically involved in a biological process as a substrate or product.
Sublingual
Under the tongue.
SUD
Abbreviation of Substance Use Disorder.
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 |