
Chief Executive
Officer’s Statement
Product Development and Regulatory Affairs (PDRA)
Pipeline Progress
We have delivered another year of consistent progress on the pipeline.
We have generated positive dose range finding data in both the dog
and cat for the diabetes drugs being developed in partnership with
Akston Biosciences. Using its recently commissioned GMP biologics
production facility, Akston Biosciences is currently on track to deliver
active ingredient for our planned pivotal efficacy studies. Lifecycle
innovation of our key brands, such as Vetoryl and Osurnia, are ongoing
and showing good progress. New opportunities are constantly being
identified and new candidates have been added to the pipeline. With
the addition of the Piedmont projects (outlined later in this report), our
pipeline is stronger than ever and positioned to deliver material products
to support future growth.
Product Approvals
Numerous marketing authorisations have been achieved throughout the
year. Although only Zenalpha
®
is material in its own right, they all add
depth and breadth to the current product range and strengthen our
international portfolio. Major approvals in Dechra territories are:
• in Europe, Metomotyl 10mg chewable tablet for dogs
(Metoclopramide hydrochloride), Bupredine
®
Multidose 0.3mg/ml
solution for injection for dogs, cats and horses (Buprenorphine),
Canergy 100mg coated tablets for dogs (Propentofylline),
Cefabam 1000mg, 250mg and 50mg tablets for dogs (Cephalexin
monohydrate), Clindacutin 10mg ointment for dogs (Clindamycin
hydrochloride), Lodisure
®
1mg tablets for cats (Amlodipine besilate),
Octacillin
®
800mg/g powder for use in water for pigs (Amoxicillin
trihydrate), Sedadex 0.1mg/ml solution for injection for dogs
and cats (Dexmedetomidine hydrochloride), Vomend
®
vet 10mg
chewable tablets for dogs (Metoclopramide hydrochloride);
• in Great Britain and Northern Ireland, Tri-Solfen
®
Solution for
Pigs (Adrenaline tartrate, Lidocaine hydrochloride, Bupivacaine
hydrochloride, Cetrimide) was approved. An exemption from the
need for a maximum residue limit (MRL) for an equine product at an
advanced stage of development was also approved;
• a novel canine sedative injection Zenalpha (Medetomidine
hydrochloride, Vatinoxan hydrochloride), a generic antibiotic
Amoxicillin Trihydrate and Clavulanate Potassium Drops and
generic Carprofen Caplets have been approved in the USA;
• two sedative products, Dexmedesed 0.5mg/ml (Dexmedetomidine
hydrochloride) and Dormazolam
®
(Midazolam) as well as the
antimicrobial Rexxolide
®
(Tulathromycin) were registered in Canada;
• in Mexico, five new products were registered;
• in Australia, four new products and in New Zealand three new
products were registered;
• in Brazil, three new products were registered including two
vaccines; and
• additionally, in other international territories, we have received 52
approvals in countries including Egypt, Iran, Korea, Pakistan, Peru,
Puerto Rico, Serbia, Sri Lanka, Switzerland, Thailand, West Africa
(UEMOA), Ukraine, United Arab Emirates, Uruguay and Vietnam.
Acquisitions
We have successfully completed several product acquisitions and two
material company acquisitions.
In July 2022, post the year end, we acquired Piedmont Animal Health,
Inc for $210 million (£175 million), a product development company
with a long, successful track record of developing major international
products for multi-national animal health companies. Piedmont has
eight novel products in various stages of development, all in the CAP
market for cats and dogs and all within Dechra’s key therapeutic areas
of competence. The business significantly strengthens Dechra’s pipeline
of novel products with two near term opportunities, both expected to
be top ten products for Dechra. The development team of 19 people
who have joined Dechra, located in Greensboro, North Carolina, have
added additional strength and expertise to the Company’s existing
product development capabilities.
Also, post the year end in August 2022 we completed the acquisition of
Med-Pharmex Holdings, Inc for $260.0 million (£221.5 million).
Med-Pharmex, with sales of $43.0 million and adjusted EBITDA of
$15.3 million, is an established platform business located in Pomona,
California with manufacturing, product development and regulatory
capabilities. It has several products already approved and established
in the US market. As they have no sales and marketing capabilities,
these products are currently sold through third party partners. We are
planning to sell many of these products under a Dechra brand through
our existing sales and marketing channels, providing material margin
synergies and operational leverage. In the longer term, synergies
will also be realised from integration and improved utilisation of the
manufacturing facilities. The facility has the capability to produce
Cephalosporins, a type of antibiotic that is required to be manufactured
in a dedicated suite. They currently have one product registered and
one product in the development pipeline that fall into this category,
which is expected to be first entrant generic in product markets of
material scale in the USA.
We executed numerous bolt on product acquisitions, which
complement our equine and CAP portfolios. The equine products
acquired are all for the US market and are:
• Rompun
®
(xylazine injection) and Butorphanol Tartrate Injection from
Elanco™ Animal Health, which complement our anaesthesia and
analgesia portfolio;
• Sucromate™ Equine (deslorelin acetate) sterile suspension from
Thorn Bioscience LLC, which expands our US Equine portfolio into
reproduction; and
• ProVet APC™ (Autologous Platelet Concentrate) and ProVet BMC™
(Bone Marrow Concentrate) systems from Hassinger Biomedical.
These two patented medical devices harness growth factors from the
horse’s whole blood, which when injected back into the horse positively
enhance healing results in soft tissue injuries. The ProVet APC™
system is a revolutionary device and is arguably the fastest and most
transportable platelet concentrator available to the veterinary industry.
The CAP products acquired are:
• LAVERDIA
®
-CA1, a novel oral SINE (selective inhibitor of nuclear
export) drug and the first oral tablet for canine lymphoma acquired
from Anivive Lifesciences Inc. It is currently sold under a conditional
approval by the FDA Center for Veterinary Medicine in the USA
with full dossier submissions planned for the USA, UK, EU, Brazil,
Australia, Japan and Canada;
• Isoflurane
®
, USP and Sevoflurane
®
, USP from Halocarbon, both
inhalant anaesthetics, which expand our US veterinary surgical suite;
• Atopivet
®
range of products for cats and dogs in collaboration
with Bioiberica, which offer unique alternatives to multi-modal
dermatology therapy; and
Dechra Pharmaceuticals PLC Annual Report and Accounts for the year ended 30 June 2022 www.dechra.com
16