Financial due diligence on a biotech or medtech target

Two accounting frameworks govern what you will see:

• US GAAP (Generally Accepted Accounting Principles), overseen by the FASB and enforced for public companies by the SEC (Securities and Exchange Commission).
• IFRS (International Financial Reporting Standards), used across the EU and UK, set by the IASB.

The single biggest difference for biotech: R&D capitalization.

Check 1: Capitalized R&D games

Under US GAAP, internal R&D is almost always expensed as incurred. Little room to play games there.

Under IFRS (IAS 38), development costs *must* be capitalized once technical and commercial feasibility criteria are met, while research is expensed. This is the fault line. A European medtech firm can argue its device passed a feasibility threshold and start moving costs to the balance sheet, cutting reported losses.

What to check:

• Compare R&D expense as a percentage of total spend, year over year. A sudden drop while headcount and trial activity rise is a red flag.
• Read the capitalization policy footnote. When exactly do they say feasibility is met? For a drug pre-approval, aggressive capitalization is hard to defend.
• Recompute the "adjusted" loss with all development costs expensed. See if the improving trend survives.

Worked calculation (illustrative): A target reports a 2025 net loss of $40M, down from $55M in 2024. You find they capitalized $20M of development costs in 2025 versus $3M in 2024.

Restated 2025 loss = $40M + ($20M - $3M) = $57M.

The loss did not shrink. It grew. The "improvement" was an accounting choice.

Check 2: Hidden milestone liabilities

Biotech deals run on milestone payments: cash owed to a partner or licensor when a candidate hits a development, regulatory, or sales trigger. A target may have licensed its lead asset and owe, say, $75M on FDA approval plus royalties on sales.

These obligations are often contingent (they only trigger on an event), so they may sit in footnotes rather than on the balance sheet, especially under GAAP where contingent payments in a licensing deal are frequently disclosed narratively.

What to check:

• Read every in-licensing and collaboration agreement. List each milestone, its trigger, and its dollar amount.
• Sum the total contingent milestone exposure. It is common for this to exceed the target's cash on hand.
• Check royalty stacking: multiple licensors each taking a percentage of future net sales can quietly erase the product's margin.

A device or drug that looks profitable at the gross level can be uneconomic once 15 percent of sales flows out in stacked royalties. Model it.

Check 3: The IP cliff

For biotech, intellectual property (mostly patents) is the moatmoatA lasting edge over competitors: a resource, capability or position they cannot easily replicate, letting a firm earn above-average returns over time.Voir la définition complète →. A patent cliff is the date exclusivity ends and generics or biosimilars can enter, collapsing revenue.

What to check:

• Get the patent schedule: expiry dates for each key patent, by jurisdiction (US and EU differ).
• Identify the composition-of-matter patent (covers the molecule itself) versus weaker method or formulation patents. Losing the former is the real cliff.
• For biologics, factor regulatory exclusivity separately from patents. In the US, the BPCIA gives biologics 12 years of data exclusivity; in the EU, the standard framework has been roughly 10 to 11 years (the EU pharma legislation reform under discussion in 2025 to 2026 may change these periods, so confirm the current rules as of your deal date).

A target whose lead product loses composition-of-matter protection in three years is a melting ice cube, regardless of current sales.

The USPTO's Patent Public Search lets you verify claimed patents and expiry math yourself for free.

Check 4: Going-concern and cash runway

Most clinical-stage biotechs burn cash and have no revenue. The question is not *if* they need more money but *when*, and whether auditors have flagged doubt.

A going-concern qualification is a statement in the audited financials that there is substantial doubt about the company's ability to operate for the next 12 months. It is a serious flag and often depresses the stock, which can also be why the target is for sale.

Cash runway calculation (illustrative):

• Cash and equivalents: $60M
• Quarterly net cash burn: $18M
• Runway = $60M / $18M = 3.3 quarters, roughly 10 months.

If a pivotal trial readout is 14 months out, this company must raise capital (dilution) or strike a deal before it has data. That is your leverage, and their risk.

What to check:

• Recompute burn from the cash flow statement, not from management's slide.
• Line up runway against the next value-inflection catalyst (trial readout, regulatory decision).
• Check for near-term debt maturities or convertible notes that could balloon dilution.

🎬 [VIDEO: "How to Read a Biotech Balance Sheet" - youtube.com - walkthrough of cash runway, R&D lines, and pipelinepipelineAll active sales opportunities across the stages of the sales process, together with their combined potential value and probability of closing.Voir la définition complète → value for non-specialists]

Check 5: Revenue quality for commercial-stage medtech

If the target actually sells a device or approved therapy, apply standard revenue scrutiny with sector twists.

• Channel stuffing: pushing inventory to distributors near quarter-end to book revenue. Check days sales outstanding (DSO) and distributor inventory levels.
• Reimbursement risk: a device only sells if payers reimburse it. In the US, a change to a CMS (Centers for Medicare and Medicaid Services) reimbursement code can gut demand overnight. Confirm coverage is stable.
• Recall and warranty reserves: medtech carries product-liability and recall exposure. Verify reserves are adequate against the FDA's public recall and adverse-event databases.

Check 6: Deferred tax assets and NOLs

Loss-making biotechs accumulate net operating losses (NOLs) that can offset future taxable income. Buyers sometimes overvalue these.

Two cautions:

• A valuation allowance is often booked against these deferred tax assets precisely because the company may never earn enough to use them. Do not credit the full number.
• In the US, Section 382 limits how much of an acquired company's NOLs the buyer can use after a change of ownership. The annual limit is roughly the target's equity value multiplied by a published IRS long-term tax-exempt rate. This can shrink a headline $200M NOL to a trickle of usable benefit per year.

Ask your tax advisor to model the Section 382 limitation before assigning any value to NOLs in your price.

Check 7: Related-party and founder arrangements

Small biotechs often have tangled relationships: founders who also own the licensing entity, consulting contracts to insiders, or IP held in a separate holding company.

What to check:

• Read the related-party transactions footnote in full.
• Confirm the core IP is owned by the entity you are buying, not licensed from a founder vehicle that can renegotiate later.
• Look for above-market consulting or lease payments to insiders that inflate the cost base but could be cut, or that signal weak governance.

Putting the checklist together

Sequence your diligence to kill the deal fast if it deserves killing:

1. Cash runway and going concern (is there time?).

2. IP cliff and composition-of-matter status (is there a moatmoatA lasting edge over competitors: a resource, capability or position they cannot easily replicate, letting a firm earn above-average returns over time.Voir la définition complète →?).

3. Capitalized R&D restatement (are the losses real?).

4. Milestone and royalty liabilities (what do you truly owe?).

5. Revenue quality, NOLs, related parties (clean-up).

The first two can end the process in an afternoon. The rest set your price.

Key Takeaways

• Restate the losses. Under IFRS especially, strip out capitalized development costs and check whether the improving trend survives. Often it does not.
• Add up contingent milestones and stacked royalties. They frequently exceed cash on hand and can erase product margin. They live in footnotes, so read the contracts.
• Find the composition-of-matter patent expiry. A near-term cliff makes strong current sales irrelevant. Verify dates yourself on public patent databases.
• Compute runway against the next catalyst. If the company runs out of cash before its key readout, that is your negotiating leverage and their existential risk.
• Discount NOLs for Section 382 and valuation allowances. A headline loss carryforward is rarely worth its face value to a buyer.

This lesson is educational and not investment, legal, or tax advice. Confirm all regulatory periods and tax rules as of your deal date with qualified advisors.