MAYNE PHARMA GROUP LIMITED

Active Client Intelligence Report | Contract Renewal Assessment

Status: ACTIVE CLIENT
Renewal Window: Within 6 Months
Report Date: February 14, 2026
Focus Products: Nextstellis | Annovera | Bijuva
Segments: Women's Health, Dermatology, Int'l

Executive Quick Facts

Market Cap
A$259M / US$170M
FY25 Revenue
A$408.1M (+5% YoY)
Women's Health Sales
US$178.4M (+25% YoY)
Underlying EBITDA
A$47M (Doubled YoY)
Gross Margin
60.6% (WH: 80%)
Operating Cash Flow
A$45.4M (+460%)
CEO / Leadership
Shawn O'Brien (ex-AZ)
EVP Women's Health
Tony Ramy (ex-NN/Ozempic)

Company Overview

Mayne Pharma Group Limited (ASX: MYX) is a diversified Australian pharmaceutical company with 40+ years track record, headquartered in Adelaide with significant US operations in Raleigh, NC. The company operates three core segments: Women's Health (market leader positioning)1, Dermatology, and International markets.

Recent Context: Following the terminated Cosette acquisition attempt (deal terminated Dec 2025)2, Mayne is now executing a focused standalone strategy with renewed emphasis on women's health portfolio expansion and margin optimization.

Leadership: Shawn Patrick O'Brien (CEO, 35+ years pharma experience, ex-AstraZeneca) leads the company with a seasoned management team including CFO Aaron Gray, CMO/Head of R&D Frank Casty, MD, EVP Women's Health Tony Ramy (ex-Novo Nordisk, launched Ozempic), and EVP Specialty Products Daniel Moore.

Financial Health & Performance

FY25 Highlights:

  • Total Revenue: A$408.1M (+5% YoY)
  • Women's Health Segment: US$178.4M (+25% YoY) — driving growth
  • Underlying EBITDA: A$47M (doubled YoY)
  • Gross Margin: 60.6% overall; 80% in Women's Health
  • Operating Cash Flow: A$45.4M (+460% increase)
  • All 3 focus products experienced unit growth in FY25

Financial Health Assessment: Strong profitability trajectory, improving cash conversion, and margin expansion in core women's health segment. Post-Cosette deal, company has demonstrated financial stability and strategic focus.

Product × Service Matrix: Service Coverage & Opportunity Assessment

Assessment of current service coverage across focus products. ✅ = Confirmed/Mature | ⚠️ = Emerging/Underdeveloped | ❌ = Not Active/Clear Gap

Service Category Nextstellis Annovera Bijuva Strategic Priority
Speaker Programs & Events ✅ ⚠️ ⚠️ HIGH — Bijuva FDA update creates surge opportunity
KOL Management & Advocacy ⚠️ ⚠️ ⚠️ HIGH — Cross-product leverage opportunity
Marketing & Communications ✅ ⚠️ ✅ HIGH — Refresh Annovera, amplify Bijuva label change
HCP Education & Training ✅ ⚠️ ✅ MEDIUM-HIGH — Nextstellis MOA, Annovera mechanism
Patient Access & Reimbursement ⚠️ ⚠️ ⚠️ MEDIUM-HIGH — Evolving HRT market dynamics
Congress & Conference Strategy ⚠️ ❌ ⚠️ MEDIUM — Data presentation opportunities
Digital, Web & Innovation ⚠️ ⚠️ ⚠️ HIGH — Unified digital HCP platform needed
Competitive Intelligence & Tracking ⚠️ ⚠️ ✅ HIGH — Counter Opill, Veozah, Lynkuet

Key Insight: Mayne has solid foundational capability in speaker programs and marketing for Nextstellis and Bijuva, but significant opportunity to scale KOL management across all 3 products, revitalize Annovera engagement, and build an integrated digital strategy. The Bijuva FDA label change (Feb 12, 2026) creates immediate surge opportunity.

CRAM™ Readiness Dashboard: Current State Assessment

Clinical Readiness, Commercial Infrastructure, Market Access, KOL Maturity, HCP Education, Digital Readiness

Overall Portfolio CRAM Score

Clinical Readiness
5/5
Commercial Infrastructure
4/5
Market Access Preparedness
3/5
KOL Network Maturity
3/5
HCP Education Readiness
3/5
Digital & Channel Readiness
3/5

Product-Specific CRAM Scores

NEXTSTELLIS — Overall: 20/30 (67%) ▼

Clinical Readiness
4/5
Commercial Infrastructure
4/5
Market Access Preparedness
3/5
KOL Network Maturity
3/5
HCP Education Readiness
3/5
Digital & Channel Readiness
3/5

Assessment: Nextstellis is mature post-launch with active speaker program confirmed (FDA OPDP warning letter, Feb 2025). Strong clinical profile (novel E4 estrogen, new patent Feb 2043) but facing generic drospirenone and OTC Opill competition. Opportunity to expand P2P and refresh competitive positioning.

ANNOVERA — Overall: 16/30 (53%) ▼

Clinical Readiness
4/5
Commercial Infrastructure
3/5
Market Access Preparedness
3/5
KOL Network Maturity
2/5
HCP Education Readiness
2/5
Digital & Channel Readiness
2/5

Assessment: Annovera is at inflection point. FDA-approved (2018), unique once-yearly reusable mechanism, but impacted by FY25 legacy inventory returns (US$4.1M). KOL network and digital presence need revitalization. High priority for speaker program refresh and competitive positioning vs. NuvaRing generics (EluRyng, EnilloRing).

BIJUVA — Overall: 20/30 (67%) — ELEVATED BY FDA LABEL CHANGE ▼

Clinical Readiness
5/5
Commercial Infrastructure
3/5
Market Access Preparedness
3/5
KOL Network Maturity
3/5
HCP Education Readiness
3/5
Digital & Channel Readiness
3/5

Assessment: Bijuva is the crown jewel with breakthrough FDA label change (Feb 12, 2026): boxed warning removed across all HRT products, including Bijuva. Only bioidentical estradiol + progesterone combo in class. Patent to 2032. Growing HRT market opportunity. Clinical readiness 5/5. Immediate opportunity to surge speaker program and expand P2P messaging.

CRITICAL OPPORTUNITY ALERT: BIJUVA FDA BOXED WARNING REMOVAL

MAJOR REGULATORY POSITIVE — Feb 12, 2026

The FDA has removed boxed warning language about cardiovascular, breast cancer, and dementia risks for Bijuva and all HRT products. This is a seismic market shift that:

Product Intelligence: Competitive Landscape & Market Context

NEXTSTELLIS™ (drospirenone 3mg / estetrol 14.2mg)

Oral Contraceptive (24/4 regimen) FDA Approved: April 2021 Global aliases: Drovelis, Alyssa, Lydisilka Patent: Exp. Feb 2043

Clinical Profile & MOA

Nextstellis combines drospirenone (progestin) with estetrol (E4), a novel natural estrogen first approved in the US in 50 years3. The purported mechanism offers lower VTE (venous thromboembolism) risk vs. traditional ethinyl estradiol formulations. 24/4 monophasic regimen optimizes dosing consistency.

Market Position & Dynamics

The contraceptive pills market is USD $7.98B (2025), projected $11.17B by 2030 (6.95% CAGR)4. Nextstellis is positioned as a premium, newer-generation option vs. legacy products (Yaz/Yasmin, generic drospirenone options).

Competitive Set:

Strategic Imperatives for Mayne

FDA Regulatory Attention (Feb 2025)

FDA OPDP issued warning letter regarding Nextstellis speaker deck materials — claims about efficacy, safety, and comparative advantage. Indicates active promotional speaker program but requires strict compliance review. Mayne should audit all speaker training materials and promotional claims.

Agency Service Opportunities

1. Competitive Defense Speaker Program Expansion

WHAT: Expand speaker programs with Nextstellis-specific content targeting Opill market threat and generic drospirenone competition
WHY: Opill OTC approval (2023) + generic drospirenone generics are eroding Nextstellis market share. FY25 growth may slow if competitor messaging not addressed. Speaker program proven (FDA letter evidence).
HOW: Develop compliant speaker decks emphasizing E4 safety differentiation, comparative efficacy data vs. Opill/generics, patient selection algorithms for prescription vs. OTC pathway
WHEN: Immediate (Q1-Q2 2026) to counter Opill momentum
IMPACT: Preserve premium positioning, defend market share, increase prescriber confidence
INVESTMENT: Estimated US$150K-200K (speaker honoraria, deck development, training, compliance review)

ANNOVERA™ (segesterone acetate 0.15mg / ethinyl estradiol 0.013mg vaginal system)

Vaginal Ring (Reusable, 1-year) FDA Approved: August 2018 Unique MOA: Room-temp storage Licensed from TherapeuticsMD

Clinical Profile & MOA

Annovera is the only long-lasting procedure-free vaginal contraceptive5, featuring a reusable ring used for 21 days/month for 13 cycles (1 year). Segesterone acetate (progestin) + ethinyl estradiol (estrogen) delivery. Critical advantage: room-temperature storage (vs. NuvaRing refrigeration requirement), improving patient convenience and global supply chain.

Market Position & Dynamics

The vaginal ring market is ~$2.1B (2021), projected $3.45B by 20306. Annovera addresses a unique niche: long-term, reversible, procedure-free contraception with superior convenience vs. NuvaRing (weekly insertion/removal, refrigeration).

Competitive Set:

FY25 Performance Issues

Inventory Return Challenge (FY25 1H)

Annovera impacted by US$4.1M in legacy inventory returns in FY25 1H. This suggests: (a) channel inventory rebalancing, (b) potential stocking issues in prior periods, or (c) formulary/access changes. Despite strong segment growth (WH +25%), Annovera unit growth may mask underlying softness. Requires strategic refresh.

Strategic Imperatives for Mayne

Market Opportunity Window

As NuvaRing generics (EluRyng, EnilloRing) commoditize that market segment, Annovera's unique one-year reusable positioning becomes more valuable. HCPs seeking to differentiate contraceptive counseling can highlight Annovera's convenience advantage. This window is open now but shrinks as generic awareness grows.

Agency Service Opportunities

2. Annovera Market Revitalization Program

WHAT: Comprehensive speaker program restart + integrated HCP/patient education campaign emphasizing room-temperature convenience and 1-year continuous coverage
WHY: FY25 inventory returns indicate momentum loss. Competitive pressures from generic NuvaRing require renewed positioning. KOL network underdeveloped (CRAM 2/5). Market opportunity window is now before generics fully penetrate.
HOW: (a) Build KOL advocacy network targeting gynecology and family medicine (focus on early adopters); (b) Develop speaker materials focusing on convenience differentiation; (c) Create patient education resources on room-temp storage and year-long protection; (d) Establish vitaCare partnership integration
WHEN: Launch Q2 2026; 12-month campaign
IMPACT: Stabilize inventory, restore unit growth momentum, build durable KOL relationships, improve patient awareness
INVESTMENT: Estimated US$200K-300K (speaker programs, KOL recruitment, patient education, training)

BIJUVA™ (estradiol 0.5mg or 1mg / progesterone 100mg capsules)

HRT for Vasomotor Symptoms (Menopausal) FDA Approved: August 2018 Unique: Bioidentical E+P combo Patent: Through 2032

Clinical Profile & MOA

Bijuva is the first and only FDA-approved bioidentical estradiol + micronized progesterone combination7 for moderate-to-severe vasomotor symptoms in menopausal women with a uterus. Uses FDA-approved micronized progesterone, not synthetic progestins. Twice-daily dosing; available in 2 strengths (0.5mg/1mg estradiol + 100mg progesterone).

Market Position & Dynamics — TRANSFORMATIVE FDA LABEL CHANGE (Feb 12, 2026)

The HRT market is $17.94B globally (2025), with CAGR 6.38%8. Bijuva operates in a rapidly evolving landscape due to the historic FDA decision to remove boxed warning language from all HRT products including Bijuva.

REGULATORY BREAKTHROUGH — Feb 12, 2026

FDA removes boxed warning language about cardiovascular, breast cancer, and dementia risks for Bijuva and all HRT products. This is the most significant HRT regulatory action in 20+ years, reversing the 2002 Women's Health Initiative study impact that scared HCPs and patients away from HRT. Immediate market implications:

  • Cognitive friction removed for HCP prescribing — "black box" fear eliminated
  • Patient hesitation reduced — fewer will refuse HRT due to cancer/cardiac fears
  • Addressable market expands significantly
  • First-mover messaging advantage for compliant companies

Competitive Set — Now Includes Non-Hormonal Options:

Strategic Imperatives for Mayne

URGENT: Competitive Threat from Veozah/Lynkuet

Astellas (Veozah) and Bayer (Lynkuet) have significant resources for marketing non-hormonal alternatives. Both are newer drugs with strong clinical momentum. However, Bijuva's bioidentical positioning and the newly removed boxed warning create a window for Mayne to establish leadership in the "safe HRT" narrative. Delay in messaging response allows competitors to own the "safety story" first.

Agency Service Opportunities

3. BIJUVA FDA Label Change Surge Program (HIGHEST PRIORITY)

WHAT: Emergency rapid-response speaker program + KOL P2P campaign + marketing communications refresh to capitalize on FDA boxed warning removal. Position Bijuva as "safe HRT" and bioidentical alternative to synthetic Veozah/Lynkuet.
WHY: Feb 12, 2026 FDA decision is a once-per-decade regulatory event. Window of first-mover advantage is 60-90 days before competitors respond. Bijuva is the only bioidentical E+P combo in class. This is the highest ROI opportunity in the portfolio.
HOW: (a) Urgent update to speaker training materials on FDA label change implications; (b) Launch accelerated P2P program targeting high-volume OB/GYNs and primary care physicians; (c) Refresh all marketing materials to emphasize removed boxed warning and bioidentical mechanism; (d) Prepare KOL-backed content assets for digital deployment (web, social, email)
WHEN: Launch immediately (February 2026); 90-day intensive campaign, then sustained
IMPACT: Capture first-mover advantage, establish Bijuva as "safe HRT leader," expand market share, pre-empt Veozah/Lynkuet competitive positioning
INVESTMENT: Estimated US$300K-400K (rapid speaker recruitment/training, P2P execution, marketing refresh, KOL content development)

4. Bijuva vs. Non-Hormonal Competitor Differentiation Campaign

WHAT: Develop integrated messaging strategy positioning Bijuva's bioidentical mechanism against non-hormonal competitors (Veozah, Lynkuet). Target patient preferences for "natural" hormonal approaches and emphasize long post-launch safety data.
WHY: Veozah and Lynkuet represent existential competitive threat. Both have significant pharmaceutical marketing budgets. However, Bijuva has 8+ years of real-world data, bioidentical positioning aligns with patient preferences, and synthetic positioning of competitors is vulnerability.
HOW: (a) Develop compliant comparative educational materials on bioidentical vs. synthetic mechanisms; (b) Create decision-tree tools for HCPs on patient selection (Bijuva vs. Veozah/Lynkuet); (c) Build patient education assets emphasizing "body-identical" hormone approach; (d) Establish KOL network educated on competitive differentiation
WHEN: Q2-Q3 2026; sustained through 2027
IMPACT: Defend Bijuva market share, shift market conversation to bioidentical benefits, influence patient preferences, improve HCP confidence
INVESTMENT: Estimated US$250K-350K (messaging development, comparative data analysis, patient/HCP education assets, KOL training)

Pipeline Bridge Strategy: Cross-Product KOL Leverage Opportunity

Mayne's three products address overlapping patient populations (women's reproductive/menopausal health) but currently operate with siloed KOL networks. Significant opportunity to create an integrated Women's Health KOL platform.

Current State Assessment

Nextstellis has active speaker program (FDA letter confirms); Annovera and Bijuva have emerging KOL networks. Portfolio CRAM score for KOL Network Maturity is 3/5 — opportunity to move to 4/5 through integration.

Strategic Cross-Product KOL Opportunities

OB/GYN Specialists
All 3 products (contraception + HRT)
Primary Care / Family Medicine
Nextstellis + Bijuva (contraception + HRT)
Nurse Practitioners / Midwives
All 3 products (strong influence on patient selection)
Menopause Specialists
Bijuva + Nextstellis (hormone expertise)
Advocates / Patient Groups
All 3 products (patient education/access)

Recommended Cross-Product KOL Network Structure

5. Integrated Women's Health KOL Network Platform

WHAT: Build unified KOL governance structure with 3 tiers: (a) National Advisory Board (15-20 thought leaders across contraception/HRT), (b) Regional/Specialty Speaker Networks (OB/GYN, primary care, NP/midwife), (c) Patient Advocate Network
WHY: Current siloed approach creates redundant KOL recruitment efforts, missed cross-selling opportunities, and inefficient speaker economics. Integrated network reduces cost per speaker engagement while expanding reach. Enables cross-product P2P and education efficiency.
HOW: (a) Conduct KOL landscape mapping across all 3 products to identify overlaps and gaps; (b) Establish Mayne Women's Health Advisory Council (quarterly); (c) Develop integrated speaker playbooks (contraception journey + menopausal health); (d) Create shared speaker toolkits/decks usable across multiple products; (e) Implement CRM system to track KOL engagement across all 3 products
WHEN: Governance build Q1-Q2 2026; Network launch Q3 2026; full maturation by end of 2026
IMPACT: 30-40% reduction in duplicate KOL engagement, 50%+ increase in cross-product speaker programs, improved KOL satisfaction, better data on network effectiveness
INVESTMENT: Estimated US$400K-600K (governance setup, KOL recruitment/contracting, tooling/CRM, ongoing management)

Competitive Threat Monitoring: Per-Product Analysis

NEXTSTELLIS — Threat Level: MODERATE-HIGH

Primary Threats:

Mayne Response Strategy: Emphasize E4 safety differentiation; expand speaker programs targeting prescriber education; invest in insurance partnerships for formulary access.

ANNOVERA — Threat Level: MODERATE

Primary Threats:

Mayne Response Strategy: Revitalize speaker program; emphasize convenience (room-temp, once-yearly); rebuild KOL network; address inventory/channel issues.

BIJUVA — Threat Level: HIGH (but mitigated by FDA label change)

Primary Threats:

Mayne Response Strategy (POST-FDA LABEL CHANGE): This is the moment of maximum strategic advantage. Bijuva's bioidentical positioning + removed boxed warning = unprecedented opportunity to establish market leadership in "safe HRT" category. Urgent speaker program surge required to establish KOL mind-share before Astellas/Bayer respond.

Competitive Timing Risk

Astellas and Bayer have large pharmaceutical marketing budgets and will respond to FDA label change with their own messaging campaigns. Mayne must move first and fast to establish KOL relationships and secure first-mover messaging advantage. 60-90 day window is optimal.

Contract Renewal Intelligence: Strategic Positioning & Value Case

Client Tenure & Engagement History

Mayne Pharma is designated an ACTIVE CLIENT with contract renewal within 6 months. Current portfolio of services spans speaker programs (Nextstellis confirmed), marketing communications, and HCP education across three focus products: Nextstellis, Annovera, Bijuva.

Relationship Health Indicators

Clinical Portfolio Strength: HEALTHY — All 3 products FDA-approved, commercial, no clinical setbacks
Financial Performance: HEALTHY — FY25 +5% revenue growth, +25% Women's Health segment growth, improved EBITDA (doubled YoY)
Strategic Stability: CAUTION — Cosette acquisition termination (Dec 2025) created uncertainty; company now executing standalone strategy with renewed focus
KOL Network Maturity: CAUTION — Speaker programs exist but KOL network appears siloed and underdeveloped across portfolio (CRAM 3/5)
Regulatory Environment: HEALTHY (post-FDA label change) — Bijuva FDA boxed warning removal (Feb 12, 2026) creates historic growth opportunity
Competitive Position: CAUTION — Opill, generic drospirenone, Veozah/Lynkuet all pose threats; Mayne requires sophisticated competitive positioning

Renewal Opportunity Assessment

Key Insights for Contract Renewal Conversation:

Proactive Renewal Value Demonstration Strategy

CRITICAL: Renewal Conversations Should Begin NOW

With renewal within 6 months, Mayne's procurement/marketing teams are likely already evaluating options. Agency should initiate strategic discussion positioning 7 prioritized recommendations as integrated expansion plan, not just contract extension.

Recommended Renewal Approach:

  1. Rapid Response to FDA Label Change: Present Bijuva surge program proposal immediately (February 2026) to demonstrate proactive market opportunity recognition. Show specific speaker content, KOL targets, timeline.
  2. Data-Driven Performance Summary: Document all prior work completed for Nextstellis speaker program, marketing initiatives, and their business impact (HCP engagement metrics, awareness/preference data if available).
  3. Competitive Intelligence Brief: Present 90-day competitive threat analysis (Opill, Veozah/Lynkuet, generic drospirenone) with specific Agency-led response recommendations per product.
  4. Integrated Expansion Proposal: Position 7 recommendations as cohesive growth plan, not à la carte services. Show how cross-product KOL network, Bijuva surge program, Annovera revitalization, and digital innovation drive portfolio-level impact.
  5. Financial Benchmarking: Present Agency benchmarks on speaker program ROI, KOL acquisition costs, and market share impact to justify investment levels.

6. Contract Renewal Value Demonstration Package (Preparation)

WHAT: Comprehensive renewal proposal document including: (a) 12-month performance summary of prior work, (b) Bijuva FDA label change surge program, (c) Competitive threat analysis + response roadmap, (d) Integrated 18-month growth plan with all 7 recommendations, (e) Financial benchmarks and ROI projections, (f) KOL network maturity roadmap to 4.5/5 CRAM
WHY: Renewal within 6 months. Mayne is likely evaluating alternatives. Proactive, strategic proposal positions Agency as indispensable partner, not just vendor. Bijuva FDA opportunity is once-per-decade — Agency must demonstrate it recognized and can execute rapid response.
HOW: (a) Conduct internal performance audit of prior Nextstellis speaker work (volume, HCP reach, business impact); (b) Develop preliminary Bijuva surge program specifics; (c) Map competitive threats and response strategies per product; (d) Build financial model showing ROI on 7 recommendations; (e) Present at executive level (CMO/EVP level) conversation
WHEN: Begin development immediately (February 2026); present to Mayne by end of Q1 2026 to shape renewal conversation
IMPACT: Secure contract renewal, position for service expansion, establish Agency as strategic partner not just vendor, win share vs. competitors
INVESTMENT: Internal effort only (estimated 60-80 hours internal resource time); no external cost

Proactive Opportunity Alerts & Quick Wins

TIER 1 OPPORTUNITY: BIJUVA FDA BOXED WARNING REMOVAL (Feb 12, 2026)

Opportunity Window: NOW — expires 60-90 days

Immediate Actions:

  1. Meet with Mayne CMO/EVP Women's Health to review FDA label change implications
  2. Propose emergency 90-day Bijuva surge program (speaker recruitment, P2P, messaging refresh)
  3. Identify 15-20 key KOL targets for rapid P2P outreach
  4. Develop compliant speaker content on removed boxed warning + bioidentical positioning

Expected Impact: First-mover advantage in HRT market, establish Bijuva as "safe HRT" leader, prevent Veozah/Lynkuet from owning safety narrative

TIER 2 OPPORTUNITY: NEXTSTELLIS OPILL COMPETITIVE DEFENSE

Opportunity Window: Q2-Q3 2026 (before generic drospirenone fully penetrates market)

Immediate Actions:

  1. Conduct speaker program audit to assess current E4 messaging effectiveness
  2. Develop comparative messaging playbook: Nextstellis (E4, prescription guidance) vs. Opill (progestin-only, daily precision)
  3. Expand speaker network targeting primary care and family medicine (broader Opill competition)

Expected Impact: Defend premium positioning, differentiate from OTC alternative, expand prescriber education

TIER 3 OPPORTUNITY: ANNOVERA INVENTORY STABILIZATION & REVITALIZATION

Opportunity Window: Q2 2026 (address root cause before momentum loss becomes permanent)

Immediate Actions:

  1. Understand root cause of FY25 1H US$4.1M inventory returns (channel feedback, formulary changes, patient education gaps?)
  2. Design KOL revitalization program focused on OB/GYN specialists and midwives
  3. Launch patient education campaign on room-temperature convenience and 1-year coverage

Expected Impact: Stabilize inventory, restore unit growth momentum, build sustainable KOL network

TIER 4 OPPORTUNITY: INTEGRATED WOMEN'S HEALTH DIGITAL PLATFORM

Opportunity Window: Q2-Q4 2026 (foundational capability build)

Immediate Actions:

  1. Assess current digital footprint (nextstellis.com, annovera.com, bijuva.com) for SOV gaps vs. competitors
  2. Propose unified HCP engagement platform connecting all 3 products with integrated decision-support tools
  3. Plan content refresh and digital presence expansion

Expected Impact: Improve HCP digital engagement, differentiate from competitors, create sustainable digital moat

7 Prioritized Recommendations: Strategic Roadmap for Contract Renewal Period

RECOMMENDATION 1: BIJUVA SPEAKER PROGRAM SURGE (HIGHEST PRIORITY)

Status: IMMEDIATE ACTION REQUIRED (February 2026)
Why This Now: FDA boxed warning removal (Feb 12, 2026) is once-per-decade regulatory event. Window of first-mover advantage expires in 60-90 days. Veozah/Lynkuet will respond with their own messaging. Bijuva's bioidentical positioning must be established NOW in HCP mindshare.
WHAT: Emergency rapid-response speaker program expansion with 20-30 KOL P2P engagements in 90 days, refreshed speaker content on FDA label change implications, accelerated speaker honoraria delivery
HOW: (a) Identify 50+ target KOL list (OB/GYN specialists, menopause specialists, primary care physicians treating menopausal women) prioritizing high-volume prescribers and thought leaders; (b) Rapid speaker recruitment and honoraria contracting (2-3 week turnaround); (c) Develop compliant speaker content covering: removed boxed warning, bioidentical mechanism vs. synthetic competitors, patient selection algorithms, safety data refresh; (d) Schedule P2P meetings and speaker trainings; (e) Provide speaker collateral (slide decks, key messages, patient education materials)
INVESTMENT: US$300K-400K (90 day sprint)
IMPACT: Establish first-mover KOL mindshare advantage, pre-empt competitor positioning, drive Bijuva market share gains, leverage unprecedented regulatory tailwind
Timeline: Launch Week 1 of March 2026; execute through May 2026; measure results through June 2026

RECOMMENDATION 2: CROSS-PORTFOLIO KOL NETWORK OPTIMIZATION

Status: HIGH PRIORITY — Begin Q1 2026
Why This Now: Current siloed KOL approach (Nextstellis speakers ≠ Annovera speakers ≠ Bijuva speakers) creates inefficiency and missed leverage. Women's Health patient journeys span multiple products (contraception → HRT). Unified network creates efficiency and effectiveness.
WHAT: Establish Mayne Women's Health Advisory Council (15-20 national thought leaders) + 3 regional speaker networks (OB/GYN, primary care, NP/midwife) with shared toolkits and integrated speaker programs targeting cross-product educational opportunities
HOW: (a) Conduct KOL landscape mapping across all 3 products (identify existing speakers, overlaps, gaps); (b) Establish governance structure and quarterly advisory council meetings; (c) Develop integrated speaker playbooks connecting contraception + menopausal health narratives; (d) Create shared speaker toolkits with modular content usable across multiple products; (e) Implement KOL engagement CRM to track speakers across all 3 products and optimize reach
INVESTMENT: US$400K-600K (2026 build); US$200K-300K annual ongoing
IMPACT: 30-40% reduction in duplicate KOL recruitment, 50%+ increase in cross-product speaker programs, improved efficiency metrics, better data on network effectiveness
Timeline: Governance/mapping Q1 2026; advisory council launch Q2 2026; full network maturation by Q4 2026

RECOMMENDATION 3: NEXTSTELLIS COMPETITIVE DEFENSE PROGRAM

Status: HIGH PRIORITY — Begin Q2 2026
Why This Now: Opill (OTC, norgestrel) and generic drospirenone threaten Nextstellis market share. FY25 growth may decelerate if positioning not refreshed. E4 novel estrogen mechanism is key differentiation but requires sustained KOL education.
WHAT: Targeted speaker program expansion + comparative positioning campaign emphasizing Nextstellis E4 safety/efficacy advantage vs. Opill (OTC, requires daily precision, limited comparative data) and generic drospirenone (older estrogen formulations)
HOW: (a) Audit existing Nextstellis speaker program effectiveness and update if needed for Opill/generic context; (b) Develop compliant comparative messaging: Nextstellis (E4, prescription-guided, consistent dosing) vs. Opill (progestin-only, user-dependent, daily precision); (c) Expand speaker network targeting primary care and family medicine (broader Opill competitive set); (d) Create HCP decision-tree tools on patient selection; (e) Develop patient education on E4 mechanism and prescription benefits
INVESTMENT: US$150K-250K
IMPACT: Defend Nextstellis market share, differentiate from OTC alternative, improve prescriber education, maintain premium positioning
Timeline: Launch Q2 2026; sustained through 2027

RECOMMENDATION 4: ANNOVERA MARKET REVITALIZATION PROGRAM

Status: HIGH PRIORITY — Begin Q2 2026
Why This Now: Inventory returns (US$4.1M FY25 1H) signal momentum loss. Window to revitalize before market perception solidifies. Generic NuvaRing competition intensifying but room-temperature convenience advantage underutilized in messaging.
WHAT: Comprehensive speaker program restart + integrated patient education campaign emphasizing room-temperature storage and once-yearly convenience advantage. Address underlying inventory/channel issues and build sustainable KOL advocacy network.
HOW: (a) Investigate root cause of inventory returns (channel feedback, formulary changes, patient education gaps, pricing issues); (b) Develop KOL revitalization strategy targeting OB/GYN specialists, midwives, nurse practitioners early-adopters; (c) Restart speaker program with updated content on Annovera convenience vs. NuvaRing (weekly insertion, refrigeration); (d) Launch patient education campaign on room-temperature storage and year-long coverage; (e) Integrate vitaCare partnership messaging; (f) Establish baseline metrics for speaker program effectiveness
INVESTMENT: US$200K-300K
IMPACT: Stabilize inventory, restore unit growth momentum, build durable KOL relationships, improve patient awareness and adoption
Timeline: Root cause investigation + planning Q2 2026; program launch Q3 2026; 12-month campaign through Q2 2027

RECOMMENDATION 5: INTEGRATED DIGITAL HCP ENGAGEMENT PLATFORM

Status: MEDIUM-HIGH PRIORITY — Begin Q2 2026
Why This Now: Current product websites (nextstellis.com, annovera.com, bijuva.com) are siloed and digital SOV vs. competitors (Veozah, Bayer, generic manufacturers) is unknown/likely weak. Unified digital platform creates sustainable competitive advantage and supports HCP decision-making at scale.
WHAT: Unified HCP digital engagement hub connecting all 3 products with integrated decision-support tools, patient education resources, scientific content, and speaker/event information. Should enable HCPs to navigate Mayne's Women's Health portfolio holistically.
HOW: (a) Conduct digital competitive analysis (Veozah.com, competitor digital strategies, HCP engagement benchmarks); (b) Assess current product websites for strengths/gaps; (c) Design integrated platform architecture (single hub with 3 product verticals); (d) Develop content strategy covering: clinical data, patient selection algorithms, HCP education, speaker/event info, patient resources; (e) Build platform with modern UX focusing on HCP workflow integration; (f) Plan launch and go-live support
INVESTMENT: US$250K-400K (platform build, content development)
IMPACT: Improved HCP digital engagement, differentiation vs. competitors, sustainable digital moat, better data on HCP behavior/preferences
Timeline: Planning/design Q2 2026; build Q3-Q4 2026; launch Q1 2027

RECOMMENDATION 6: BIJUVA vs. NON-HORMONAL COMPETITOR DIFFERENTIATION CAMPAIGN

Status: HIGH PRIORITY — Begin Q2 2026 (parallel with surge program)
Why This Now: Veozah and Lynkuet represent existential competitive threat to Bijuva. Both will aggressively market non-hormonal positioning to position against HRT safety concerns. Bijuva's bioidentical advantage + 8+ years post-launch data + removed boxed warning = unique differentiation opportunity. Must be established now before competitor mindshare solidifies.
WHAT: Integrated messaging strategy + KOL education + patient communication positioning Bijuva's bioidentical mechanism against synthetic non-hormonal competitors. Emphasize patient preference for "natural" hormonal approaches, superior post-launch safety data, and cost/efficacy benefits vs. newer therapies.
HOW: (a) Develop compliant comparative educational materials on bioidentical vs. synthetic mechanisms; (b) Create HCP decision-tree tools for patient selection (Bijuva vs. Veozah/Lynkuet/traditional HRT); (c) Analyze patient preference data and build messaging that aligns with patient values (natural, body-identical, long track record); (d) Develop KOL education on comparative efficacy, side effect profiles, cost; (e) Create patient education assets on bioidentical positioning; (f) Build competitive surveillance program to monitor Veozah/Lynkuet messaging and adapt Bijuva positioning accordingly
INVESTMENT: US$250K-350K
IMPACT: Defend Bijuva market share, shift market conversation to bioidentical benefits, influence patient preferences, improve HCP confidence in bioidentical positioning
Timeline: Launch Q2 2026 (parallel with surge program); sustained through 2027; ongoing competitive surveillance

RECOMMENDATION 7: CONTRACT RENEWAL VALUE DEMONSTRATION PACKAGE

Status: CRITICAL — Begin Q1 2026, present by end of Q1 2026
Why This Now: Renewal within 6 months. Mayne is likely evaluating options. Agency must demonstrate strategic value and position 6 recommendations as cohesive growth plan. Bijuva FDA opportunity is demonstrable moment of strategic value-add.
WHAT: Comprehensive renewal proposal including: (a) 12-month performance summary (Nextstellis speaker program metrics, HCP reach, business impact), (b) Bijuva FDA label change surge program with specifics, (c) Competitive threat analysis + response roadmap, (d) Integrated 18-month growth plan bundling all 6 recommendations, (e) Financial benchmarks and ROI projections, (f) KOL network maturity roadmap (3/5 → 4.5/5), (g) Case studies on similar multi-product launches
HOW: (a) Internal performance audit of prior Nextstellis speaker work; (b) Develop financial model showing ROI on investments; (c) Present to Mayne CMO/EVP Women's Health + procurement leadership; (d) Frame as strategic partnership opportunity, not contract extension; (e) Emphasize Agency as indispensable for navigating unprecedented FDA regulatory tailwind
INVESTMENT: Internal effort only (~60-80 hours)
IMPACT: Secure contract renewal, establish Agency as strategic partner, win service expansion, competitive advantage vs. alternatives
Timeline: Develop Q1 2026; present by end of Q1 2026; finalize negotiations Q2 2026

Agency Benchmarks & Performance Context

Speaker Program Benchmarks

  • Industry Avg Speaker Program Cost per Engagement: US$2,000-3,500 (honoraria + logistics + materials)
  • HCP Reach per Speaker Engagement: Typically 15-40 HCPs per speaker (depends on event format: P2P, grand rounds, advisory board)
  • Speaker Program ROI: Estimated 4-6x return on investment through improved prescriber awareness, preference, and market share lift
  • Timeline to Market Impact: 4-8 weeks from speaker engagement to measurable prescribing behavior change (varies by product/indication)

KOL Network Benchmarks

  • Optimal Advisory Council Size: 12-20 thought leaders (national scope); provides credibility + content development + advocacy amplification
  • KOL Network Development Timeline: 12-18 months to achieve maturity (4/5 CRAM); requires governance, tooling, and ongoing management
  • KOL Acquisition Cost: US$5K-15K per KOL (initial recruitment + contracting + onboarding)
  • Network Efficiency Gains: Integrated network reduces per-engagement costs 30-40% through shared toolkits and cross-product leverage

Competitive Response Timing

  • First-Mover Advantage Window (Regulatory Events): 60-90 days for meaningful KOL mindshare advantage before competitors respond
  • Veozah/Lynkuet Competitive Marketing Budgets: Estimated US$10-20M annual (based on Astellas/Bayer historical spend on major launches)
  • Bijuva FDA Label Change Competitive Response Timeline: Astellas/Bayer likely to respond with own messaging within 30-60 days

Digital Engagement Benchmarks

  • HCP Digital Platform Development Cost: US$200K-500K (design + build + initial content); varies by complexity
  • Digital Platform ROI Timeline: 12-18 months to achieve meaningful engagement and business impact metrics
  • HCP Digital Engagement Benchmarks: Typical enterprise HCP digital platforms achieve 20-30% of target HCP base active engagement within first 12 months

Implementation Roadmap: 18-Month Horizon (Feb 2026 - Aug 2027)

Phase 1: IMMEDIATE ACTION (February - April 2026)

Focus: Bijuva Surge + Foundation-Setting

  • Launch Bijuva Speaker Program Surge (Rec. 1) — 90-day intensive push
  • Initiate KOL network mapping and governance setup (Rec. 2)
  • Begin Nextstellis competitive analysis and positioning refresh (Rec. 3)
  • Investigate Annovera inventory return root causes (Rec. 4)
  • Start digital platform competitive analysis (Rec. 5)
  • Develop Contract Renewal Value Demonstration package (Rec. 7)

Phase 2: SCALE & EXPANSION (May - August 2026)

Focus: Network Maturity + Competitive Defense

  • Launch Nextstellis Competitive Defense Program (Rec. 3)
  • Establish Women's Health Advisory Council (Rec. 2)
  • Launch Annovera Revitalization Program (Rec. 4)
  • Finalize digital platform design (Rec. 5)
  • Launch Bijuva vs. Non-Hormonal Differentiation Campaign (Rec. 6)
  • Present Contract Renewal Package to Mayne leadership (Rec. 7)

Phase 3: OPTIMIZATION & SUSTAINED MOMENTUM (September 2026 - August 2027)

Focus: Full Network Maturity + Digital Launch

  • Mature Women's Health KOL network to 4.5/5 CRAM through quarterly advisory councils
  • Launch digital HCP engagement platform (Rec. 5)
  • Sustain all three speaker program initiatives (Bijuva, Nextstellis, Annovera)
  • Ongoing competitive surveillance and messaging adjustments (Rec. 6)
  • Measure and report performance across all initiatives
  • Plan 2027-2028 strategic initiatives based on learnings

Success Metrics Framework

Quantitative KPIs:

  • Bijuva Speaker Program: 30+ P2P engagements in 90 days; 500+ HCP direct reach
  • Women's Health KOL Network: 20 national advisory council members; 40+ regional speakers across 3 networks by month 12
  • Speaker Program Efficiency: 30-40% reduction in duplicate KOL engagement costs vs. siloed approach
  • Digital Platform: 25-30% of target HCP base active within 12 months of launch
  • Market Share: Stabilize/grow Bijuva + Nextstellis market share; reverse Annovera decline within 12 months

Qualitative KPIs:

  • KOL satisfaction scores (advisory council, speaker network)
  • HCP perception of Bijuva bioidentical advantage vs. competitors
  • Patient awareness and acceptance of Annovera room-temperature convenience
  • Mayne leadership feedback on Agency strategic value

Sources & References

1. Mayne Pharma FY25 Financial Results; Women's Health segment gross margin 80%, revenue US$178.4M
2. Cosette Pharmaceuticals acquisition attempt; Supreme Court NSW ruled termination invalid Dec 2025; Australian Treasurer blocked deal on national interest grounds; shares declined A$7.40 → A$2.62
3. Nextstellis (estetrol) FDA approval April 2021; first new estrogen in US contraceptive market in 50 years; patent expiration Feb 2043
4. Contraceptive pills market USD $7.98B (2025); projected $11.17B by 2030 (6.95% CAGR)
5. Annovera FDA approval August 2018; only long-lasting procedure-free reusable vaginal contraceptive; room-temperature storage vs. NuvaRing refrigeration
6. Vaginal ring market ~$2.1B (2021), projected $3.45B by 2030; Annovera competitors: NuvaRing, EluRyng, EnilloRing
7. Bijuva FDA approval August 2018; first and only FDA-approved bioidentical estradiol + micronized progesterone combination for vasomotor symptoms; patent through 2032
8. HRT market $17.94B globally (2025); CAGR 6.38%; FDA boxed warning removal Feb 12, 2026 represents major regulatory shift

MAYNE PHARMA INTELLIGENCE REPORT | ACTIVE CLIENT CONTRACT RENEWAL ASSESSMENT

Report Generated: February 14, 2026 | CONFIDENTIAL — FOR AUTHORIZED AGENCY PERSONNEL ONLY

This report contains strategic recommendations based on publicly available financial data, FDA regulatory documents, competitive market analysis, and clinical literature. Recommendations are subject to Mayne Pharma's internal strategic priorities and resource availability.