Bio4life4you Limited

Plant-powered dermocosmetics with clinical credibility; Barrier-first skincare for challenging conditions; Non-steroidal comfort, hydration, and appearance care;
Science + nature for visible skin relief; EU-compliant, vegan dermocosmetics—ready to scale; Neem-based actives, modern clinical validation; Everyday routines for complex skin needs; From case evidence to consumer scale

Product

GLUCK NEEM®: patented, vegan dermocosmetics (A–Acne, P–Psoriasis/Eczema, C–Chronic Wounds, B–Burn Care); formulations finalized and manufacturing-ready.

Evidence

Observational case documentation across burns, venous ulcers, graft aftercare, abrasions, and psoriasis (patient permissions secured, incl. Korea 2022).

Lab irritation model (SLES 1%) shows signals consistent with barrier recovery support (hydration/TEWL, erythema, microcirculation).

HRIPT tolerance testing completed; non-allergenic in tested cohorts (internal reports).

Regulatory & Compliance

Built for EU 1223/2009 cosmetics: claim frame = comfort, hydration, appearance, barrier care (no therapeutic claims).

Vegan and sustainability posture aligned; INCI and labeling frameworks prepared.

Brand & Assets

Investor-facing website (case gallery, contact funnel) live-ready.

8 visual case studies prepared + 8 A4 investor handouts (PDFs).

Outlook-ready email campaign drafted for VC and strategic audiences.

Commercial Readiness

Supply chain options evaluated; GMP-capable manufacturing paths under review.

Go-to-market plan: hospital/wound-care, pharmacy, and D2C subscriptions.

Funding

Seeking capital to initiate first production, market launch, and distributor onboarding.

Near-Term Milestones (next 90–120 days)

Lock manufacturing partner & first PO; final packaging & compliance checks.

Pilot placements (wound/burn centers) + pharmacy sell-in in priority EU markets.

Publish 3–5 standardized case series and launch D2C retention program.

Targeting hospital, pharmacy, and D2C with EU-compliant, plant-based dermocosmetics—credible enough for clinicians, accessible enough for everyday use.

1) Institutional (B2B2C)

Who: Wound-care & burn units, dermatology clinics, plastic surgery/aftercare, outpatient nursing.

Use cases: Peri-wound/burn skin care, graft/aftercare routines, sensitive-skin barrier support between/around Rx cycles.

Buyer/influencer: Department heads, procurement, KOL clinicians, nursing leads.

Drivers: EU-compliant cosmetics, easy protocol fit, patient comfort/appearance, documentation, dependable supply.

2) Pharmacy / Retail

Who: Hospital-adjacent and community pharmacies; dermocosmetic aisles.

Use cases: Psoriasis/eczema maintenance, acne routines, post-procedure care kits.

Buyer/influencer: Category managers, pharmacists/dermo-cosmeticians.

Drivers: Indication-specific story (A/P/C/B lines), staff training, repeat purchase, premium but accessible price point.

3) Direct-to-Consumer (D2C)

Who: Adults with recurrent psoriasis/eczema flares, acne-prone consumers, caregivers for sensitive skin.

Use cases: Daily, non-steroidal routines for comfort, hydration, and appearance; subscriptions and bundles.

Drivers: Visible outcomes storytelling, trust (clinical tone, HRIPT), convenience, community/education.

4) Strategic / B2B

Who: Distributors (wound/derm), private-label partners, hospital suppliers.

Use cases: Regional manufacturing/distribution, co-branded kits, channel expansion.

Drivers: Dossiers, supply reliability, margin structure, training assets.

Market (claim-safe framing)

Positioning: Non-steroidal dermocosmetics (EU 1223/2009) focused on comfort, hydration, appearance, and barrier care—sitting between Rx (efficacy expectations/monitoring) and commodity OTC (access/price), with premium cosmetics economics.

Beachhead → Expansion

Phase 1 (EU): Portugal/Spain → Germany/France (pharmacy & hospital pilots + D2C).

Phase 2: Distributor-led hospital/pharmacy in EMEA (+ select APAC where KOL ties exist).

Phase 3: Broader retail & D2C scale; private-label where strategic.

TAM / SAM / SOM (how to present)

TAM (top-down): Dermocosmetics + psoriasis/eczema/acne + peri-wound/burn skin-care categories.

SAM (filtered): Regions where we’re compliant and can distribute in 12–24 months.

SOM (bottom-up): # pilot centers × kits/patient/month + pharmacy doors × units/door/month + D2C subs × ARPS.
(We can drop in your actual unit assumptions and roll up to revenue.)

Adoption triggers by segment

Institutional: KOL endorsement, simple protocols, patient comfort feedback, procurement-ready docs.

Pharmacy: Staff recommendation, planogram presence, in-store testers, repeat purchase data.

D2C: Before/after galleries, routine builders, subscriptions, customer stories (consented).

Core KPIs

Institutional pilots launched → reorder rate;

Pharmacy doors activated → units/door/month;

D2C subscriptions → retention (60/120-day), CAC/LTV;

Supply: OTIF, defect rate, returns.

Problem

Chronic skin conditions (psoriasis, acne, wounds/burns) cause recurring discomfort, visible stigma, and high care burden.

Standard care leans on steroids/immunosuppressants—effective but linked to side effects, access hurdles, and poor long-term adherence.

Patients and clinicians want non-steroidal, daily-use options that support barrier care, hydration, comfort, and appearance—without clinical complexity.

Opportunity

Rapid shift toward plant-based, vegan dermocosmetics with credible evidence and EU-compliant (1223/2009) claims.

Cosmetics regulatory path = lower risk, faster market entry, global scalability; strong premium margins and subscription potential.

GLUCK NEEM® is manufacturing-ready, supported by case documentation (with consent) and HRIPT tolerance—positioned for hospital/wound-care, pharmacy, and D2C channels.

Problem: Chronic skin needs lack safe, credible, everyday relief.
Opportunity: EU-compliant, plant-based dermocosmetics that deliver visible comfort and scale fast.

Problem: Steroid-heavy care ≠ long-term daily use.
Opportunity: Non-steroidal, barrier-first routines with premium cosmetics economics.

Decision — Seed €1.0–2.0M

Choose your path (pick one or combine):

Invest (VC/FO): Lead or co-lead €1.0–2.0M to fund first production, GTM, and scale. Target ≈18-month runway with milestones across manufacturing, pilots, and revenue.

Strategic partnership: Regional manufacturing/distribution with MOQs and co-marketing; optional equity/warrants.

Pilot deployment: 90–120 day pilots in wound/burn/derm centers with standardized outcomes capture and post-pilot scale.

Use of funds (ranges reflect €1.0–2.0M):

Inventory & initial manufacturing: 35–45% → €350k–€900k

GTM & clinical marketing (KOLs, case capture, pharmacy sell-in): 25–35% → €250k–€700k

Working capital & ops (team, logistics, QA): 15–20% → €150k–€400k

Regulatory, QA, packaging & compliance: 5–10% → €50k–€200k

D2C stack & data (site, subscriptions, analytics): 5–10% → €50k–€200k

Why act now

Manufacturing-ready, EU-compliant cosmetics (1223/2009): de-risked path to market.

Documented case journeys + HRIPT tolerance (non-allergenic in tested cohorts).

Multi-channel scale: hospital/wound-care, pharmacy, and D2C with premium cosmetics economics.

Milestones (first 12–18 months)

0–3 mo: Lock contract manufacturer, final packaging, first PO.

3–6 mo: Pilot placements (wound/burn centers), initial pharmacy sell-in, launch D2C.

6–12 mo: Expand distribution, publish standardized case series, subscription retention >40%.

12–18 mo: Regional scale-up, repeat orders, path to breakeven.

1) Rx drugs (topicals & biologics)

Examples: corticosteroids, vitamin-D analogs, calcineurin inhibitors; systemic biologics.
Strengths: strong efficacy data; physician-driven adoption.
Limits: side effects, high cost, access/monitoring; not ideal for long-term everyday use.
Our angle: adjunct care focused on comfort, hydration, appearance, and barrier support between/around Rx cycles (EU-cosmetic compliant).

2) Advanced wound/burn dressings

Examples: hydrocolloid/foam/alginate/hydrofiber dressings; silver dressings; silicone scar gels.
Strengths: entrenched clinical workflows; reimbursable in settings.
Limits: higher cost; focus on coverage, not daily skin comfort; limited consumer continuity.
Our angle: periwound/burn skin care and daily routines that complement dressings; easy pharmacy/D2C access.

3) OTC dermocosmetics / barrier creams

Examples: ceramide moisturizers; CICA/copper-zinc repair balms; colloidal oat lines.
Strengths: safe, accessible, widely trusted.
Limits: crowded, commodity messaging; limited indication-specific storytelling.
Our angle: plant-powered (neem) formulations with visual case documentation, clear A/P/C/B line architecture, and clinician-led education.

4) “Natural/herbal” skincare

Examples: aloe, calendula, tea-tree, neem creams (mass-market).
Strengths: “clean/vegan” appeal; broad retail footprint.
Limits: variable quality; scarce clinical documentation; inconsistent claims discipline.
Our angle: clinical credibility + regulatory rigor (EU 1223/2009; HRIPT tolerance; dossiers; KOL backing), plus manufacturing readiness.

Product

Non-steroidal, plant-based dermocosmetics (neem-driven) built for daily use and sensitive skin.

Clear line architecture (A/P/C/B): Acne, Psoriasis/Eczema, Chronic Wounds (peri-care), Burn Care.

Patented formulations; vegan/bio-certified; sustainable sourcing.

Evidence & Safety

Consented case documentation (burns, wounds, psoriasis) with strong visuals.

Irritation-model signals consistent with barrier recovery support (hydration/TEWL).

HRIPT tolerance completed (non-allergenic in tested cohorts).

Regulatory & Risk

EU 1223/2009 cosmetics pathway → faster entry, lower risk vs. Rx.

Claim-safe framework: comfort, hydration, appearance, barrier care (no therapeutic claims).

Dossiers, INCI, labeling, and QA files ready.

Commercial Readiness

Manufacturing-ready with GMP-capable partners and scalable BOMs/packaging.

Multi-channel GTM: hospital/wound-care, pharmacy, and D2C subscriptions.

Premium cosmetics margins; kit bundles and regimen repeatability.

Brand & Team

Clinician-led (Dr. Joaquim Morgado) with a decade+ of neem R&D and collaborations.

Proof-first storytelling: standardized imagery, case handouts, and HCP materials.

Positioning vs. Alternatives

vs. Rx drugs: everyday, accessible peri-care that supports comfort/appearance between and around treatment cycles.

vs. commodity OTC: clinical credibility + regulatory rigor + indication-specific line and visual outcomes.

So what (why it wins)

The sweet spot between Rx efficacy expectations and OTC accessibility—credible, compliant, and ready to scale.

Revenue Streams

Institutional (B2B2C): Kits for wound/burn/derm centers (starter + refill), peri-care routines, post-procedure packs.

Pharmacy/Retail (Wholesale): Indication-specific SKUs (A/P/C/B), clinic-adjacent and community pharmacies.

Direct-to-Consumer (D2C): Subscriptions and regimen bundles (maintenance/flare routines).

Strategic B2B: Regional distribution, private-label/co-brand SKUs, selective licensing.

Pricing & Margin Targets (indicative, ex-VAT)

Unit MSRP: €25–€45 | Kits: €60–€120

Gross margin targets: D2C 70–80% · Pharmacy 55–65% · Institutional 50–60%

Wholesale discounts: 40–55% off MSRP (category-standard); trade promos 5–10%.

Unit Economics (illustrative examples, ex-VAT)

D2C single SKU — price €36; COGS €8 → gross margin €28 (~78%).
Fulfilment €3; payments ~€1.4; paid CAC €10 → contribution ≈ €13.6 (~38%).

Pharmacy wholesale — MSRP €36; wholesale €18 (50%); COGS €8 → gross margin €10 (~56%).
Freight/trade promo ~€1.4 → contribution ≈ €8.6 (~48%).

Institutional kit — tender €100; COGS €35 → gross margin €65 (65%).
Field sales/service €10 → contribution ≈ €55 (55%).
Notes: ex-VAT; figures are illustrative ranges to guide planning.

Cost Structure

Variable (per unit/order)

COGS: actives/raws, packaging, fill/finish, QA release.

Channel costs: wholesale discounts, trade promos, distributor margins.

D2C costs: pick-pack-ship, payment processing, returns.

Demand gen: paid media/CAC, sampling, KOL seeding.

Fixed / Semi-fixed

People & Ops: ops lead, QA/RA, light commercial, customer care.

Regulatory & QA: PIF upkeep, safety/claims substantiation, CPNP, labeling.

Manufacturing readiness: tooling, stability/compatibility, artwork.

Overheads: 3PL fees, insurance, legal, rent, systems.

Levers to Improve Margins

BOM optimization & MOQs: negotiate raws/packaging; larger runs to reduce € per unit.

Mix shift: grow subscriptions/kits (higher AOV, lower CAC/retention), increase D2C share.

Trade efficiency: targeted pharmacy sell-in, limit blanket discounting, focus on top doors.

Ops: automate filling/labeling, reduce failure/return rates, optimize 3PL.

Recurring Revenue Drivers

Subscriptions (psoriasis/eczema maintenance), refill cadence from clinics/pharmacies, and post-procedure kits tied to provider protocols.

Business Model

Revenue mix:
Institutional kits (B2B2C) · Pharmacy wholesale · D2C subscriptions & bundles · Strategic B2B (private label/licensing)

Positioning: Non-steroidal dermocosmetics (EU 1223/2009) focused on comfort, hydration, appearance, and barrier care.

Pricing architecture: Single SKUs (€25–€45), Kits (€60–€120), Subscription discount (10–15%), Clinic packs (tiered).

Margins: D2C 70–80% · Pharmacy 55–65% · Institutional 50–60% (targets).

Repeat engine: Indication-specific routines (A/P/C/B), refills, and clinic-to-home continuity.

Channels (GTM)

Institutional (hospital/wound/burn/derm)

Entry via KOL pilots → standardized protocols → clinic kits + refills.

Pharmacy/Retail

Doors near hospitals + dermocosmetic aisles; staff training, testers, planograms.

Direct-to-Consumer

Case galleries, routine builder, subscriptions, email education, community.

Strategic/B2B

Regional distributors, co-manufacturing/private label, clinical suppliers.

Core Metrics (with targets)

Growth & Efficiency

CAC (by channel): D2C ≤ €12 MoM; Pharmacy €/door acquisition ≤ €250; Institutional pilot ≤ €3k/site.

Payback (D2C): ≤ 2 orders; LTV/CAC ≥ 3.0 within 12 months.

AOV (D2C): ≥ €42; Subscription mix: ≥ 35% of D2C orders.

Retention & Repeat

D2C 60-day retention: ≥ 45% · 120-day: ≥ 30%

Units/door/month (pharmacy): ≥ 18 in top 50% doors

Clinic reorder rate (90 days): ≥ 70%

Commercial Quality

Gross margin: D2C ≥ 75%, Pharmacy ≥ 60%, Institutional ≥ 55%

OTIF (on-time, in-full): ≥ 96% · Return/defect rate: ≤ 1.5%

Funnel KPIs (site)

CVR (sessions→purchase): ≥ 3.0%

Email capture rate: ≥ 4.5% · Email revenue share: ≥ 25% of D2C

Content→product click-through (case pages): ≥ 12%

Pilot/Clinical Adoption

Pilots live: 5–10 centers

Pilot → paid conversion: ≥ 60%

Case studies published/quarter: ≥ 6 (consented, standardized)

Operating Cadence

Weekly: CAC, CVR, AOV, subscription %; pharmacy units/door; OTIF.

Monthly: LTV/CAC, retention, pilot conversions, top-door performance, contribution margin by channel.

Quarterly: New doors/sites, reorder rates, case publications, BOM/margin improvement.

Flywheel (how it compounds)

KOL pilot → consented case outcomes → gallery/email content → pharmacy sell-in & D2C subs → repeat/reorders → more KOLs and regions.

Money will be spent on

1) Manufacturing & Inventory (35–45%) — €350k–€900k
Tech transfer to GMP partner, raw materials (MOQs), packaging/tooling, stability & compatibility, first two production runs (A/P/C/B).

2) Go-to-Market & Clinical Marketing (25–35%) — €250k–€700k
KOL pilots (wound/burn/derm), pharmacy sell-in & training, outcomes photography with consent, conferences/HCP materials, launch PR.

3) Working Capital & Operations (15–20%) — €150k–€400k
Ops lead + QA/RA support, light commercial hire, logistics/3PL, insurance, legal, rent, contingency buffer.

4) Regulatory, QA & Compliance (5–10%) — €50k–€200k
PIF updates, safety assessments, extended HRIPT/consumer-use, claims substantiation, CPNP notifications, multilingual labeling.

5) Digital/D2C & Data (5–10%) — €50k–€200k
Site & subscriptions, CRM/email, analytics & attribution, GDPR/privacy, performance creative, CRO on funnels.

Risks & Mitigations

Regulatory / Claims (EU 1223/2009; “borderline” risk)

Risk: Claims drifting into therapeutic territory; country-by-country nuances.

Mitigate: Claims governance (comfort/hydration/appearance/barrier only), Safety Assessor sign-off, PIF completeness, pre-launch copy review & distributor training.

Watch: Any regulator or distributor edits to copy; complaint rate.

Evidence base / Perception

Risk: Observational cases ≠ RCTs; clinician skepticism.

Mitigate: Standardized case capture (consent, timelines), consumer-use data, irritation-model replication, publish non-promotional summaries; KOL pilots.

Watch: HCP conversion from pilot→paid; media/peer feedback.

Quality & Safety (cosmetovigilance)

Risk: Batch variability, adverse skin reactions.

Mitigate: ISO 22716 GMP alignment, HRIPT extensions, lot traceability, CAPA process; stable supplier specs.

Watch: Adverse event rate >0.5%/month, return/defect rate >1.5%.

Manufacturing & Supply

Risk: CMO capacity, MOQs, lead-time shocks, raw cost swings.

Mitigate: Secondary suppliers for actives/packaging, safety stock (6–8 weeks), S&OP cadence, change-control in QAA.

Watch: OTIF <96%, lead times slipping >20%.

IP / Brand protection

Risk: Narrow patent scope; fast followers; trademark conflicts.

Mitigate: FTO checks, trademark coverage in target regions, protect process know-how as trade secrets, watermark clinical imagery.

Watch: Marketplace look-alikes; opposition filings.

Market adoption / Commercial

Risk: Slow pharmacy sell-in; D2C CAC volatility; clinic protocol inertia.

Mitigate: KOL-led pilots, clinic kits with protocols, focused door activation, balanced paid/owned media; pricing/pack tests.

Watch: CAC > €12 (D2C) for 4 weeks; units/door/month < 12 after 60 days; pilot→paid < 60%.

Pricing & Margin pressure

Risk: Discounting in retail; BOM inflation.

Mitigate: BOM optimization, tiered packs/kits, promo guardrails, mix shift to subscriptions/D2C.

Watch: Gross margin dip >3 pts QoQ.

Channel conduct / Compliance

Risk: Distributor mis-marketing; HCP inducement issues.

Mitigate: Contractual claim rules, compliance playbook, audits, templated materials.

Watch: Off-label claims in market.

Data privacy & imagery ethics (GDPR)

Risk: Consent gaps for patient photos; personal data misuse.

Mitigate: Written, revocable consent; anonymization/blur; DPA with vendors; takedown SOP.

Watch: Takedown requests; DPIA findings.

Jurisdiction expansion

Risk: US and some markets treat similar claims as drug claims.

Mitigate: Region-specific labeling/claims; local counsel; stage market entry.

Watch: Regulatory inquiries during localization.

Financial / Runway

Risk: Under-raise; slip between PO and cash conversion.

Mitigate: Seed €1.0–2.0M gated to POs/pilots; rolling 13-week cash forecast; contingency cut list.

Watch: Cash < 6 months; PO delays >30 days.

Product liability / Reputation

Risk: Consumer complaints, social backlash.

Mitigate: Product liability insurance, clear IFUs/warnings, rapid response team, recall protocol.

Watch: Negative sentiment spikes; severity of complaints.