San Diego, CAMarch 2026$3-5MCONFIDENTIAL

Table of Contents

Section 01

The Market Opportunity

The peptide wellness market is massive and accelerating across every segment.

US Compounding Pharmacy

By 2034 (from $6.7B in 2025); 503B growing at 7.63% CAGR — fastest segment

Global Peptide Therapeutics

By 2035 (from $52.6B); US alone projected at $160.3B by 2030 at 16.2% CAGR

US Medical Spa Market

By 2035 (from $8.4B); 14% CAGR; 24% uptick in membership sales in 2024

Cosmetic Peptide Skincare

By 2033 (from $2.62B); 12.3% CAGR; GHK-Cu alone projected at $594M–$1.6B by 2032

Section 02

The Regulatory Landscape — A Critical Shift

The FDA enforcement environment has fundamentally changed. The grey-market model is collapsing — but for licensed, compliant pharmacies, this is a once-in-a-decade opportunity. Competitors are leaving while demand grows.

Enforcement Actions (2024–2026)

  • 50+ FDA warning letters to peptide companies (Sept 2025 alone)
  • 30 warning letters to telehealth companies (Dec 2024)
  • 40+ state AGs coordinating enforcement nationally
  • Tailor Made Compounding: $1.79M forfeiture, owner 3yr probation
  • All American Peptide: $3M+ forfeiture, guilty plea
  • Peptide Sciences ($7.4M/month) voluntarily shut down March 6, 2026
  • Courts rejected "research use only" disclaimers as a "ruse"

19 Peptides Moved to Category 2 (BANNED)

BPC-157, TB-500, CJC-1295, Ipamorelin, Thymosin Alpha-1, KPV, Epitalon, Selank, Semax, MOTS-C, and others.

GLP-1 Compounding BANNED

Semaglutide and tirzepatide off shortage list. Novo Nordisk and Eli Lilly actively suing compounders. ITC General Exclusion Order blocking tirzepatide imports.

RFK Reclassification Catalyst

HHS Secretary Kennedy announced ~14 peptides will return to Category 1 — NOT YET IMPLEMENTED. Cannot build a plan around it, but must be positioned to capitalize within 24–48 hours of announcement.

Section 03

What Can and Cannot Be Compounded Today

✅ Legally Compoundable (503A)

🚫 BANNED from Compounding (Cat 2)

Section 04

Our Competitive Advantages

Direct API Sourcing

Existing relationship with premier Chinese manufacturer provides 50–80% cost advantage over US distributors. Logistics already established.

Deep Marketing Expertise

15+ years of digital marketing, SEO, CRM, workflow automation, and B2B sales. Existing clinic relationships from prior client work.

$3–5M Committed Capital

Sufficient for full 503A launch and early 503B development. PIC candidates already sourced.

San Diego Biotech Ecosystem

2,000+ life science companies, 76,000 workers, $56B economic output, UCSD talent pipeline.

Market Timing

Competitors shutting down (Peptide Sciences, Amino Asylum), creating a supply vacuum while demand accelerates.

Dual Brand Architecture

ROVN (men's) and VYXN (women's) for targeted, gender-specific market positioning.

Section 05

Brand Architecture — ROVN + VYXN

Section 06

Cosmetic Product Line Deep Dive

Launch Products — 4 SKUs per brand (8 total), all at 87%+ gross margins:

COGS Advantage

GHK-Cu from US suppliers: $25–75/gram. Our China direct cost: $8–15/gram. Savings of $10–36 per unit. Most DTC brands buy pre-formulated at 3–5x raw material cost.

Why Cosmetics First

  • Zero regulatory barrier — cosmetic, not drug
  • Revenue within 60–90 days
  • Sell on Shopify, Amazon, retail channels
  • Builds customer base that converts to pharmacy patients
Section 07

Business Model — Three-Phase Vertical Integration

Phase 1: Cosmetics

Launch and establish the initial e-commerce cosmetics line.

Phase 2: Compounding

Expand into specialized pharmacy compounding services.

Phase 3: 503B Facility

Develop a full-scale manufacturing facility for production.

Each phase builds on the last — cosmetics fund pharmacy build-out, pharmacy revenue funds the 503B facility. Revenue channels span D2C cosmetic, D2C prescription, B2B wholesale, affiliate marketing (10–20% commission), and private label white-labeling for clinics.

Section 08

Four Strategic Approaches Analyzed

The original plan — generating early cash flow through research compound e-commerce — faces extreme legal risk. Multiple companies executing this exact model have been raided, shut down, or criminally prosecuted. The core tension: Phase 1 enforcement permanently kills Phases 2 and 3.

Approach A

Compliance-First Accelerator
Skip research compounds. Fast-track pharmacy. Zero risk, longest runway to revenue.

Approach B

Cosmetic Bridge + Pharmacy
Launch cosmetic brand immediately. Build pharmacy in parallel. Early revenue, zero risk.

Approach C

Research Compounds + Max Armor
Original plan with $500K+ legal defense reserves. Fastest revenue but EXTREME risk.

Approach D ⭐

Hybrid (RECOMMENDED)
Cosmetic bridge + accelerated pharmacy + reclassification-ready infrastructure.

Approach A

Approach A -

Compliance-First Accelerator

Skip research compounds entirely. Redirect all capital toward building a licensed 503A pharmacy as fast as possible. Zero regulatory risk.

Timeline

Months 1–2

Legal foundation, entity formation, PIC recruitment

Months 2–7

Facility lease, cleanroom build-out, equipment installation

Months 7–12

Qualification, validation, CA BOP inspection and license

Months 12–36

Scale D2C, expand catalog, 503B planning

Financials

1

Year 1

$60K–$180K

2

Year 2

$960K–$3M

3

Year 3

$3M–$7.8M

Pros

Zero criminal exposure, clean licensing record, capital preservation, standard payment processing, positioned for reclassification.

Cons

No revenue for 9–15 months, $500K–$700K upfront burn, limited initial catalog, requires partner patience.

Approach B

Approach B -

Cosmetic Bridge + Pharmacy

Launch ROVN and VYXN cosmetic peptide brands immediately (60–90 days) as a revenue bridge while building the 503A pharmacy in parallel. Under the FD&C Act, cosmetics require no FDA pre-market approval, prescriptions, or pharmacy licenses.

How Cosmetics Feed the Pharmacy Pipeline

2–4%

Website visitor → cosmetic customer

60–80%

Cosmetic customer → email subscriber

5–15%

Email subscriber → telehealth inquiry

40–60%

Telehealth inquiry → active patient

Financials

  • Year 1: $250K–$700K
  • Year 2: $1.7M–$4.4M
  • Year 3: $3.4M–$7.8M

Key Milestones

  • Month 3: First cosmetic revenue ($5K–$16K/month)
  • Months 4–12: Scale cosmetics to $30K–$80K/month
  • Months 9–15: Pharmacy goes live
  • Months 15–36: Full dual-channel operations
Approach C

Approach C -

Research Compounds with Maximum Armor

"Maximum Armor" Costs

  • Complete entity insulation between research and pharmacy
  • Sell ONLY to verified research institutions
  • $500K+ liquid legal defense reserves locked away
  • Criminal defense counsel retained on standby before launch
  • Pre-launch legal opinion: $25K–$50K
  • Full-time compliance officer: $50K–$100K/year
  • Total armor cost: $620K–$765K before selling a single product

Precedent Cases

Peptide Sciences

$7.4M/month — voluntarily shut down; model no longer viable

Tailor Made Compounding

$1.79M forfeiture, 3yr probation + 4mo house arrest

All American Peptide

$3M+ forfeiture, guilty plea

Amino Asylum

FDA warehouse raid, site went offline

Recommended

Approach D — Hybrid (RECOMMENDED)

Cosmetic Bridge + Accelerated Pharmacy + Reclassification-Ready Infrastructure. Three simultaneous workstreams delivering zero legal risk, revenue in 60–90 days, and the highest risk-adjusted return of all four approaches.

Workstream 1

Launch ROVN + VYXN cosmetic e-commerce immediately — revenue in 60–90 days

Workstream 2

Fast-track 503A pharmacy — license applications and construction begin Day 1

Workstream 3

Build reclassification-ready infrastructure (dormant) — SOPs, API inventory, prescriber education for all 14 target peptides

Recommended

Approach D — Financial Projections

WITHOUT Reclassification (Conservative)

  • Year 1: $360K–$1.2M
  • Year 2: $1.7M–$3.6M
  • Year 3: $3.4M–$6.2M

WITH Reclassification (Bull Case)

  • Year 1: $360K–$1.2M
  • Year 2: $3.1M–$6M
  • Year 3: $8.2M–$15.6M

Why Approach D Wins

Zero Legal Risk

Partners' personal freedom is never at risk. Insurance fully obtainable at standard rates.

Revenue in 60 Days

Cosmetics generate cash flow immediately. No capital wasted on legal defense reserves.

Highest Risk-Adjusted Return

Wins in both conservative and bull scenarios. Builds maximum long-term enterprise value.

Side-by-Side Comparison Matrix

Risk-Adjusted Return Analysis

Section 9

Product Line Strategy — Risk-Tiered Catalog

Tier 1 — Safe Bets

Launch Immediately

  • GHK-Cu Topical (cosmetic)
  • Argireline + Matrixyl Serums
  • NAD+ (all forms)
  • Sermorelin, Gonadorelin
  • Bacteriostatic Water

Tier 2 — High Upside

Ready Upon Reclassification

  • BPC-157 (highest demand)
  • TB-500, Thymosin Alpha-1
  • Epitalon, Semax, Selank, KPV
  • AOD-9604, MOTS-c
  • GHK-Cu Injectable

Tier 3 — Calculated Gambles

Evaluate Carefully

  • CJC-1295/Ipamorelin (regulatory limbo)
  • PT-141 (must justify vs Vyleesi)
  • Tesamorelin (BLA complications)
  • VIP (Category 1 but threatened)

Tier 4 — Do Not Touch

Too Risky Under Any Circumstance

  • Semaglutide, Tirzepatide
  • Melanotan II (melanoma risk)
  • MK-677 (CHF signal)
  • GHRP-2/GHRP-6 (death reports)
  • Dihexa, PEG-MGF, Tesofensine

Pre-Built Protocol Bundles (Pharmacy Phase 2): "Wolverine" Injury Recovery ($500–$800/mo) | Anti-Aging Core ($400–$600/mo) | Metabolic Reset ($400–$700/mo) | Cognitive Performance ($300–$500/mo) | Immune Optimization ($600–$1,000/mo) | Sexual Wellness Men ($200–$350/mo) | Sleep and Recovery ($500–$800/mo)

Section 10

Revenue Channels and Margin Analysis

Cosmetic E-Commerce (Phase 1)

COGS: $7–$18/unit | Retail: $49–$89 | Gross margin: 70–88%
Shopify + Amazon + affiliate. Subscription revenue with strong retention.

503A Pharmacy D2C (Phase 2)

Total COGS: $16–$41/vial | D2C retail: $120–$350/vial | Gross margin: 87%
Net contribution after shipping + CAC: 54–61%

503B Wholesale B2B (Phase 3)

COGS at scale: $10–$22/vial | Wholesale: $45–$100 | Gross margin: 78%
Monthly recurring revenue from clinic accounts. Medspas expect 2–3x markup to patients.

Affiliate + Private Label

Affiliate: 10–20% commission; 15–25% of e-commerce revenue. Private label: $50K–$400K/month at scale. Research peptide customers spend $15K–$50K annually with 85%+ retention.

Section 11

3-Year Financial Projections — Approach D

3-Year Revenue Summary

EBITDA Trajectory

  • Year 1: -$402,500 (investment phase)
  • Year 2: +$480,000 (15% margin)
  • Year 3: +$1,727,000 (22% margin)

Break-Even

  • Cosmetics only: Month 5–6 (~$35K–$47K/mo)
  • Full operations: Month 22–26
  • Self-sustaining: Month 18–24
Section 12

Capital Allocation — $4M Budget

Capital Call Schedule

1

Call 1 — Month 0

$500K | Phase 0 legal foundation + cosmetic brand launch

2

Call 2 — Month 4

$500K | Cosmetic scaling + Phase 2 pharmacy planning

3

Call 3 — Month 8

$750K | 503A facility build-out and equipment

4

Call 4 — Month 12

$750K | 503A operations launch + full staffing

5

Call 5 — Month 18

$750K | 503B facility initiation

6

Call 6 — Month 24

$750K | 503B facility completion

Capital calls are staged to preserve partner liquidity. Phase 1–2 revenue should offset later capital needs. If cosmetic brand exceeds projections, Calls 5 and 6 may be reduced. Total reserves held: $750K (general contingency $400K + regulatory $200K + market pivot $150K).

Section 13

Entity Structure and Legal Insulation

Multi-Entity Holding Structure (Wyoming + California)

Why Wyoming for Holding Entities

  • No state income tax
  • Strongest charging order protection
  • Strong privacy protections
  • $60/year annual report fee

Critical Insulation Rules

  • Separate bank accounts, EINs, and insurance per entity
  • No shared employees between segments
  • Arm's-length inter-company transactions with written agreements
  • Each entity adequately capitalized

Formation: $20K–$35K initial | $17K–$27K annual maintenance (including $4,800 CA franchise tax for 6 entities)

Section 14

Facility and Location Strategy — San Diego

San Diego ecosystem: 2,000 life science companies | 76,000 workers | $56B economic output | $3.6B VC deployed in 2024. UCSD produces more STEM graduates annually than Stanford and UC Berkeley combined.

Miramar / Mira Mesa ⭐ Recommended

$10–$14/sq ft annually. Strong industrial base. FedEx facility nearby. Best for Phase 1–2 transitional facility.

Kearny Mesa

$14–$18/sq ft. Central location, excellent highway access. Best for smaller Phase 2 operations.

Sorrento Valley

$16–$24/sq ft. Premier life science corridor near UCSD. Existing cleanroom spaces may reduce build-out costs.

Section 15

Telehealth Prescriber Network

Primary Platform: DrCare247

  • Purpose-built for D2C telehealth-to-pharmacy workflow
  • Direct compounding pharmacy integration via DoseSpot e-prescribing
  • Full white-label capability for branded ROVN/VYXN patient portals
  • Dual-mode: synchronous video + asynchronous evaluation
  • Nationwide physician network for rapid launch
  • Cost: $200–$500/provider/month

Secondary: WellSync (Scale Phase)

End-to-end white-labeled virtual care. LegitScript certified. Powered The Vitamin Shoppe's telehealth service.

Patient Flow Design

01

Visit

Customer visits ROVN or VYXN website

02

Questionnaire

Completes health questionnaire via white-label DrCare247 portal

03

Consult

Asynchronous physician review or synchronous video consultation

04

Rx

Prescription sent directly to in-house pharmacy

05

Ship

Pharmacy compounds and ships directly to patient (cold chain)

Section 16

Supply Chain and API Quality

Primary Supplier

Chinese API manufacturer (existing relationship) — 50–80% cost advantage over US distributors. Logistics already established.

Supply Chain Risk Mitigation

  • Qualify 2–3 backup US-based FDA-registered suppliers
  • Maintain 3-month safety stock inventory
  • Cold chain logistics required (2–8°C)
  • Third-party COA testing for every batch through accredited US lab

API Quality Requirements for Pharmacy Compounding

Section 17

Risk Register

Critical Risks

High Risks — Key Mitigations

CA BOP Licensing Delays (4–12 months)

Submit applications immediately; engage pharmacy consultant; have all documentation prepared in advance.

FTC Enforcement Against Marketing Claims

Attorney review of all marketing copy; no unsubstantiated health claims; cosmetic claims only.

Anti-Kickback Violations in Telehealth

Fixed-fee MSA; arm's-length structure; specialist healthcare attorney.

PIC Departure Disrupts Pharmacy Operations

Competitive compensation ($143K–$165K + $25K retention bonus); backup PIC candidate identified.

Section 18

36-Month Roadmap

Months 1–2: Triple Launch

Form all 7 entities. Retain pharmaceutical regulatory attorney. Verify Chinese API supplier FDA registration. Begin ROVN/VYXN cosmetic brand development with CA Botana. Begin PIC recruitment. File CA BOP pre-consultation request. File trademark applications.

Months 2–6: Revenue + Build

First cosmetic revenue: $15K–$40K/month. Email list: 2,000–5,000 subscribers. Facility lease signed. Cleanroom construction begins. Reclassification-ready SOPs drafted for 14 target peptides. 3–5 physicians contracted.

Months 6–12: Construction + Pharmacy Go-Live

Cosmetic revenue: $30K–$60K/month. Cleanroom qualification and validation. CA BOP pharmacy license obtained. Pharmacy soft launch: Sermorelin, NAD+ (4 formats), GHK-Cu Rx, PT-141. Combined revenue: $60K–$120K/month.

Months 12–18: Dual Revenue Scale

Cosmetics: $60K–$100K/month. Pharmacy D2C: $60K–$200K/month. IF reclassification occurs: immediately add BPC-157, TB-500, Thymosin Alpha-1. Revenue with reclassification: $200K–$400K/month.

Months 18–36: Full Vertical Integration

Operations self-funded from revenue. 503B construction and validation complete. Multi-state licensing (20–40 states). B2B wholesale launches with pre-committed clinic customers. Year 3 annualized revenue: $5M–$10M+. EBITDA margin: 20–25%.

Section 19

Immediate Next Steps — Next 30 Days

Week 1: Legal and Strategic

  1. Retain pharmaceutical regulatory attorney (Frier Levitt, Holt Law, or Cohen Healthcare Law Group)
  1. Verify Chinese API manufacturer FDA registration — check FDA Drug Establishment Registration database
  1. All partners reach consensus on Approach D

Week 2: Entity Formation

  1. Engage business formation attorney — draft and file all 7 entities
  1. Apply for EINs for all formed entities
  1. Open separate business bank accounts per entity
  1. File trademark applications for ROVN and VYXN

Week 3: Operations Launch

  1. Begin PIC recruitment via pharmacy-specific job boards
  1. Engage commercial real estate broker — Miramar, Kearny Mesa, Sorrento Valley
  1. Begin cosmetic brand development — select CA Botana, set up Shopify, place formulation orders
  1. File CA Board of Pharmacy pre-consultation request

Week 4: Strategic Positioning

  1. Begin prescriber network outreach — identify 5–10 physicians
  1. Engage specialty insurance broker — GL, product liability, D&O, cyber
  1. Set up daily regulatory monitoring: FDA Federal Register, PCAC, RFK updates, AB 2442, OFA v. FDA
  1. Schedule 30-day partner check-in meeting
Section 20

The Exit Opportunity

What We Are Building Is Highly Acquirable

  • Licensed, multi-channel peptide wellness company
  • Dual premium DTC brands (ROVN + VYXN) with proven cosmetic revenue
  • Operational 503A pharmacy with established telehealth network
  • 503B outsourcing facility (operational or in construction)
  • Reclassification-ready infrastructure — first-mover advantage
  • Direct API sourcing providing structural cost advantage
  • Valuable IP portfolio (trademarks, domains, formulations, SOPs)

Potential Acquirers

  • Hims and Hers ($2.35B revenue, 2.5M subscribers)
  • Empower Pharmacy (largest US compounding pharmacy)
  • Telehealth platforms seeking pharmacy vertical integration
  • PE-backed pharmacy rollup groups
  • Life science companies seeking D2C peptide channel
5–8x

EBITDA Multiple

Potential exit valuation range

$28M

Max Exit Value

At Year 3 with reclassification upside