Technical Qs Flashcards
How is the healthcare industry segmented?
Life Sciences (e.g. Johnson&Johnson, Pfizer, Merck etc.)
- Biotech
- Large Pharma
- Specialty Pharma
- Generics
Healthcare Services (Ex: UnitedHealth Group; Humana; McKesson)
- Other Services: HCIT, Pharmacies, Contract Research Organizations
- Payers: Health Insurers, or Center for Medicare & Medicaid Services
- Providers: Hospitals, Urgent Care, Rehab Facilities, Home Health etc.
Med-Tech (ex: Baxter, Boston Scientific)
- Medical Devices
- Medical Equipment
What are the main differences between biotech and other types of pharma companies?
Broadly put, biotech companies use living organisms to create their drugs, whereas the other life sciences categories develop their drugs using chemical compounds. Biotech companies are typically very high growth and based around one product/therapeutic area. Other sub-sectors in the life sciences industry, such as large pharma, are far more diversified with more product lines across several therapeutic areas (e.g., Pfizer, Merck).
What do inpatient and outpatient refer to when discussing providers?
Inpatient and outpatient are two common ways to segment the services that healthcare providers offer.
- Inpatient Care: Treatment where the patient stays overnight at a hospital or a comparable facility.
- Outpatient Care: Refers to facilities where patients receive treatment but don’t stay overnight.
Tell me the difference between acute and post-acute care.
Acute Care: Acute care refers to receiving treatment at a hospital and is associated with shorter-term, often severe injuries and medical emergencies – e.g., urgent care, intensive care units (ICUs), and emergency room services.
Post-Acute Care: Medical treatment received at non-hospital healthcare facilities is classified as post-acute care and can range from short-term rehabilitation to longer-term restorative care. These are all services beneficiaries receive after treatment at an acute care hospital – e.g., physical therapists, skilled nursing, rehabilitation facilities, and psychiatric care.
An illustrative sample care continuum would flow from the Primary Care Physician (PCP) -> Hospital (Acute) -> Rehab Facility, Skilled Nursing Facility (Post-Acute) -> Physical Therapy (Post-Acute).
What are the two channels for pharmaceutical drug distribution?
Retail Pharmacy Channel
- In the retail channel, the product flows from the branded pharma or generics company to a distributor that’s typically aligned with a particular retail pharmacy and then onto the retail pharmacy before finally reaching the customer.
- On the funds side, customers’ co-pay just passes through the retail pharmacy onto the PBM. The amount the customer essentially pays and their premium goes from the payer to the PBM based on the negotiated drug prices for the drugs on the formulary (i.e., list of covered drugs).
- For funds flowing out of the PBM, the PBM will pay the retail pharmacies based on those negotiated prices, and the retail pharmacies will pay the pharma and generic companies based again on the negotiated prices. There is much negotiation involved throughout the chain and opportunities for PBMs or retail pharmacies to earn a spread by negotiating different prices with different parties.
- The result being industry consolidations with payers and PBMs merging and retail pharmacies and payers merging to reduce opportunities for “excess” profit from the spread and lead to better margins.
Mail Order Channel
- In the mail-order channel, the products go directly from the generic or branded pharma company to a typically PBM operated mail order facility and then onto the customer. The funds, the customer’s co-pay, go directly to the PBM, and then the payers pay the PBM based on those negotiated drug prices.
- Then it’s the PBMs who will pay the pharma and generic companies for the cost of that product based on the negotiated drug prices.
What is the biggest cost driver for pharma companies?
- Research & Development (R&D): For pharma companies, clinical trials related to R&D are by far the highest cost. These trials typically take five to seven years going through the various stages of clinical trials (i.e., FDA approval for a product, regulatory hurdles, application acceptances).
- Production Costs: R&D is followed by the costs of producing pharmaceutical products, which refer to active pharmaceutical ingredients (API) manufacturing.
- Sales & Marketing (S&M): The third cost is sales & marketing, usually directed at physicians and patients – however, this trails the previous two by a large margin.
What roles do pharmacy benefit managers (PBMs) play in the industry?
Pharmacy benefit managers (PBMs) directly negotiate drug prices with retail pharmacies and influence the prices of the products – as their job essentially is to manage the pharmaceutical spend for insurers and to keep drug costs as low as possible. PBMs get paid on the spread between what payers pay them for drugs and what they payout to the retail pharmacies and pharma companies, which further incentivizes them to lower the drug prices. Once a doctor has prescribed a particular drug, the script is handed to a retail pharmacy, and the PBMs dictate which drug to dispense (i.e., a brand or generic). PBMs reduce costs by negotiating drug prices with drug manufacturers and retail pharmacies and driving generic utilization and mail order penetration.
Explain the purpose of rebates in the context of pharmaceutical pricing.
Rebates are essentially discounts offered to PBMs by pharma companies to incentivize them to include them in their list of covered drugs (called a formulary). Therefore, PBMs maintain on behalf of the payers a schedule of which drugs are covered for their customers and at what prices. Particularly when there’s high competition for a drug product, a pharma company might give bigger rebates to the PBMs to ensure they remain on the list of the covered drugs – at the expense of reduced product revenue.
What type of services do contract research organizations (CROs) provide?
CROs operate clinical trials on behalf of pharma and biotech companies in an outsourced, contractor-type relationship. CROs are hired to manage and lead the medical company’s clinical trials and to perform other specialized tasks to help bring a particular drug/medical device to the market and obtain regulatory approval quicker. Client organizations contract with CROs to use their expertise, which is required to carry out these high-stake trials safely and in a cost-efficient manner – since CROs are an alternative to having to hire permanent, dedicated staff members with the required skill set.
What is the difference between a branded and generic pharma company?
A generics company (e.g., Teva Pharmaceuticals) develops and sells generic drugs, which are allowed for sale once the patents on the original branded drugs have expired. Given the commoditized nature of these no-brand name drugs, the generics business model and competition amongst one another is based on winning fixed volume contracts for mass production. Research & development costs are lower for generics companies since there are fewer clinical trials involved. However, sales & marketing costs targeted at retail pharmacies are higher since competition is based on securing those contracts with retail pharmacies. In contrast, branded pharma companies (e.g., Novartis) have patent exclusivity which enables them to compete on product innovation and reputation of quality, rather than pricing-based competition.
What are the two pathways for a generics drug being approved?
There are two pathways for approving a generics drug:
- Paragraph lll: First, there’s the Paragraph lll filing, often called the standard channel. This is when the generics companies wait out until a patent expires and then markets it at the same time as other generics.
- Paragraph IV: The other channel is called a Paragraph IV filing – when a generics company challenges a patent before it expires. If this is approved by the FDA, the generic company can gain 180 days of exclusivity before other generics can come in. This is a pathway that most generics companies use if they think they have grounds to challenge a patent.
Let’s say you’re valuing a pharmaceutical company selling drugs approved for therapeutic usage. What would the basic drivers of revenue be?
For the typical pharmaceutical company, the most basic drivers of revenue growth would be the current number of patients using their drugs, the average price of the drug, and the average dosage of the medication recommended by the medical professional.
What assumption would you look at to value a clinical-stage biotechnology company?
A biotech company typically consists of a portfolio of different experimental drug candidates. Because each experimental drug candidate is unique and specific, we must value them separately. We must determine the annual free cash flow of each experimental drug candidate, then use discounting principles to determine the net present value of each unique product. Biotech companies are very cash-dependent, so the company’s current cash balance is also crucial when determining the full equity value of a biotech company.
Model Assumptions:
1. Number of Products in Pipeline/Development Stage: In the first assumption, the number of products under development and the current development phase for each must be identified. Then, it must be determined whether the company has a discovery platform of pre-clinical models and research.
- Peak Opportunity: Determining the potential peak revenue opportunity within a therapeutic area is often the most important assumption. Sales will grow modestly after the company has achieved peak revenue until patent expiry or loss of exclusivity. Loss of exclusivity means that a brand name drug will lose its exclusive rights to sell in a certain geography.
- Indication: The indication refers to the use of that drug for treating a particular disease/condition. More specifically, an indication is a specific, identifiable condition that the FDA has cleared a therapeutic drug to treat and can be thought of as a subcategory to a broader therapeutic area.
- Estimated Time for Completion: The estimated time for completion refers to how long it’ll take for the biotechnology company to complete all necessary clinical trials.
- Launch Date: Once you have determined the estimated time for completion, you can estimate a launch date for the drug. Once the product has officially launched, you can apply an uptake curve that grows each year until the estimated peak revenue is achieved.
What does the “probability of success” rate refer to in receiving FDA approval?
Depending on the targeted therapeutic area, certain drug candidates have a higher probability of success than others. But overall, research has shown that it’s very difficult to achieve “approval” status from the FDA.
When modeling a revenue forecast build for clinical-stage biotechnology companies, the probability of success rate (called the “POS”) must be multiplied to each product line, excluding research & development. The risk-adjusted revenue would then be calculated as the unadjusted revenue multiplied by the cumulative POS rate.
Provide an overview of the path to becoming an approved therapy by the FDA.
FDA Approval Phases
Pre-Clinical Discovery: Non-human testing to determine what a safe dosage for humans would be or if it even is safe to proceed with human testing (i.e., animal testing)
Phase 0: An exploratory study usually involving fewer than 15 test subjects and dosage on the lower end due to safety concerns
Phase 1: Human tests to determine if the treatment is safe while testing for the highest dose in humans without serious side effects (typically involves 20 to 80 test subjects)
Phase 2: Continued human tests to determine if the treatment works and testing specific dosing to observe response and efficacy (can involve a few dozen to 300+ test subjects)
Phase 3: Further human tests to determine if the treatment is better and testing the therapy against currently available therapies and treatments (ranges from several hundred to 3,000 test subjects)
New Drug Application (NDA): Formal application submission asking for approval by the FDA – once an NDA is received, the FDA has ~60 days to decide whether to proceed with the process of review.
Phase 4: Involves a thorough drug review by the FDA on all submitted data (e.g., studies conducted, labeling plan, and manufacturing facilities inspections) before making a formal decision on the application