LTR Pharma Ltd Secures U.S. ROXUS Deal for 150,000 Units in First Year

By Josua Ferreira -
  • LTR Pharma has executed a definitive Telehealth Distribution Agreement with Shed Holdings LLC on 17 July 2026, converting the June 2026 binding Term Sheet into a full long-form commercial contract governing U.S. distribution of ROXUS®.
  • Shed has committed to support delivery of not less than 150,000 ROXUS units in the first 12 months following Commercial Launch, with this threshold underpinning Shed's two-year DTC exclusivity.
  • ROXUS® is already live on Shed's Mavrox men's health platform with a patient waitlist building, signalling pre-launch commercial activity is underway ahead of a formal launch date.
  • The full U.S. commercial supply chain is now in place, with Strive Specialties Inc. secured as the exclusive pharmacy fulfilment partner holding compounding and shipping licences across all 50 states.
  • No specific Commercial Launch date has been disclosed — LTR Pharma has stated it will update the market as the remaining launch conditions are satisfied.

U.S. commercial agreement secured: LTR Pharma converts Shed Term Sheet into definitive deal

LTR Pharma (ASX:LTP) has executed a definitive Telehealth Distribution Agreement with Shed Holdings LLC, a leading U.S. direct-to-consumer (DTC) telehealth platform. The agreement, dated 17 July 2026, converts the previously announced binding Term Sheet into a comprehensive long-form commercial agreement governing the planned U.S. commercialisation of ROXUS®.

The definitive agreement converts the binding Term Sheet with Shed that was announced in June 2026, under which the two-year DTC telehealth exclusivity granted to Shed was structured as performance-dependent, with LTR Pharma retaining the right to revert to non-exclusive status if minimum volume thresholds were not met.

Under the deal, Shed has committed to support delivery of not less than 150,000 ROXUS units during the first 12 months following Commercial Launch. This marks another milestone in the company’s U.S. commercialisation strategy.

Deal at a glance

The following table summarises the key structural elements of the agreement.

Deal Element Detail
Partner Shed Holdings LLC (U.S. DTC telehealth)
Product ROXUS® (rapid-onset intranasal ED treatment)
Commercialisation platforms Mavrox™ (men’s health) and tryshed.com
Volume commitment Not less than 150,000 units, first 12 months post Commercial Launch
Agreement type Definitive Telehealth Distribution Agreement (converts binding Term Sheet)

Why this partnership matters for LTR Pharma

The agreement establishes a clear division of responsibilities between the two companies. Shed brings an established patient acquisition engine, licensed telehealth infrastructure, a clinician network and digital marketing capability developed over many years. LTR Pharma contributes a clinically differentiated, rapid-onset intranasal treatment platform.

Through the arrangement, LTR Pharma gains access to an established U.S. direct-to-consumer commercial platform without the time and capital required to build its own patient acquisition and telehealth infrastructure.

Each party brings distinct capabilities to the collaboration:

LTR Pharma & Shed: Division of Capabilities

  • Shed: patient acquisition engine, licensed telehealth infrastructure, clinician network, digital marketing capability

  • LTR Pharma: differentiated rapid-onset intranasal ED treatment (ROXUS®)

Shed’s commitment to support delivery of not less than 150,000 units in the first 12 months following Commercial Launch forms part of the agreed performance framework underpinning Shed’s ongoing exclusivity. According to the company, the definitive agreement further reduces execution risk as LTR Pharma advances toward U.S. commercialisation.

LTR Pharma Executive Chairman, Lee Rodne

“We’ve now moved from signing a binding Term Sheet to executing a definitive long-form commercial agreement with a partner that has built a highly capable direct-to-consumer telehealth platform. We believe this provides LTR Pharma with a credible, scalable pathway into the U.S. market.”

Understanding the DTC telehealth model

A direct-to-consumer telehealth model uses a digital platform to connect patients with clinician consultation and prescription fulfilment online. Patients complete a consultation through the platform and, where clinically appropriate, receive treatment delivered directly to them.

This model suits erectile dysfunction (ED) treatment for several reasons. It offers a discreet and convenient pathway for patients, and it supports subscription-based, recurring prescription programmes, which is the format Shed specialises in across multiple therapeutic areas.

For LTR Pharma, the investor angle is capital-light market entry. The arrangement allows the company to reach U.S. patients at scale by using Shed’s existing infrastructure rather than building its own. ROXUS® is positioned as a point of differentiation, with the company reporting an onset of action of 10 minutes or less.

Morley Baker, Chief Executive Officer of Shed and Mavrox, noted that Mavrox will launch with ROXUS as its hero product, describing the rapid-onset intranasal option as “primed for customer success.”

The road to Commercial Launch

With the definitive agreement executed, both parties are now focused on completing the remaining implementation activities required to support Commercial Launch. Preparatory work is already underway, with ROXUS now featured on the Mavrox platform and a patient waitlist established ahead of launch.

Completing the commercial supply chain alongside the Shed telehealth arrangement, LTR Pharma has also secured an exclusive US pharmacy fulfilment partner in Strive Specialties Inc., which holds compounding and shipping licences across all 50 states and provides the national distribution infrastructure required to fill prescriptions generated through the Mavrox platform.

The pathway to Commercial Launch can be summarised as follows:

  1. Definitive agreement executed (done, 17 July 2026)

  2. Implementation activities underway

  3. ROXUS live on Mavrox platform, patient waitlist building

  4. Commercial Launch (pending, conditions to be satisfied)

The company has stated it will update the market as Commercial Launch conditions are satisfied. No specific launch date has been disclosed.

LTR Pharma’s broader commercialisation strategy

LTR Pharma is a commercial-stage pharmaceutical company that delivers therapies through its proprietary intranasal drug-delivery platform. The company has already commercialised its rapid-acting treatment technology in Australia while advancing regulatory pathways in the U.S. and other key markets.

Its lead products, SPONTAN® and ROXUS®, are fast-acting intranasal sprays for the treatment of erectile dysfunction, enabling onset of action in 10 minutes or less. Building on this technology, the company is also advancing OROFLOW®, a novel intranasal spray under development for the treatment of Oesophageal Motility Disorders (OMD).

The Shed agreement reflects the company’s broader strategy of expanding its global footprint through established healthcare partners, aiming to deliver differentiated, patient-centric treatments across key markets.

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Frequently Asked Questions

What is the LTR Pharma ROXUS US commercial agreement with Shed Holdings?

LTR Pharma has executed a definitive Telehealth Distribution Agreement with Shed Holdings LLC, a U.S. direct-to-consumer telehealth platform, governing the commercialisation of ROXUS® — its rapid-onset intranasal erectile dysfunction treatment — through Shed's Mavrox men's health platform and tryshed.com.

How many ROXUS units has Shed committed to in the first year?

Shed has committed to support delivery of not less than 150,000 ROXUS units during the first 12 months following Commercial Launch, with this volume threshold forming part of the performance framework underpinning Shed's two-year DTC exclusivity.

When will ROXUS launch commercially in the United States?

LTR Pharma has not disclosed a specific Commercial Launch date, but has confirmed that implementation activities are underway, ROXUS is already live on the Mavrox platform with a patient waitlist building, and the company will update the market as launch conditions are satisfied.

Who is handling pharmacy fulfilment for ROXUS in the US?

Strive Specialties Inc. has been secured as LTR Pharma's exclusive U.S. pharmacy fulfilment partner, holding compounding and shipping licences across all 50 states to fill prescriptions generated through the Mavrox telehealth platform.

What happens if Shed does not meet its volume commitment under the agreement?

The agreement is structured so that Shed's two-year DTC exclusivity is performance-dependent — if minimum volume thresholds are not met, LTR Pharma retains the right to revert the arrangement to non-exclusive status.

Josua Ferreira
By Josua Ferreira
Partnership Director
Josua Ferreira holds a Bachelor of Commerce in Marketing and Advertising and brings a background in publication, business development, and ASX market storytelling. He has worked with listed companies across the resource sector and broader market, combining sharp commercial instincts with a genuine commitment to keeping investors informed.
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