Hyloris Pharmaceuticals SA engages in the develop, manufacture, and deliver pharmaceutical products to address unmet medical needs in cardiovascular health, oncology, women's health, and other major therapeutic areas. The company offers cardiovascular products for atrial fibrillation, acute coronary syndrome, advanced heart failure, congestive heart failure, acute coronary syndrome, and coronary heart disease. It also provides other products, such as post operation pain, dental indications, severe and recurring vulvovaginal candidiasis, acute myeloid leukemia and small cell lung cancer, IC/PBS, attention deficit hyperactivity disorder, and viral infection. Hyloris Pharmaceuticals SA was incorporated in 2012 and is headquartered in Liège, Belgium.

Hyloris Pharmaceuticals SA

We are a specialty biopharma company focused on innovating, reinventing, and optimising existing medications to address important healthcare needs and deliver relevant improvements for patients, healthcare professionals and payors.

We have built a broad proprietary pipeline of complex value-added reformulated and repurposed products that have the potential to offer significant advantages over currently available medications. Today, we have two, partnered commercial-stage products, Sotalol IV for the treatment of atrial fibrillation, and Maxigesic® IV, a novel, dual mode-of-action non-opioid analgesic for the treatment of post-operative pain. 

Our development strategy of reformulating and repurposing approved pharmaceuticals primarily utilises the 505(b)(2) regulatory pathway in the U.S. and similar pathways in other countries, which are specifically designed for pharmaceutical agents for which the safety and efficacy have already been established. This focused strategy can dramatically reduce the clinical burden required to bring a product to market, and significantly shortens the development timelines while also reducing costs and risks.

Hyloris is based in Liège, Belgium. 
For more information, visit www.hyloris.com.

Meusinvest (Noshaq)

Saffelberg Investments

Scorpiaux

Hyloris Pharmaceuticals

Hyloris Pharmaceuticals announces FDA Approval for Podofilox Gel targeting genital and perianal warts. 

This is the second U.S. market approval of the year for Hyloris Pharmaceuticals after Maxigesic® IV.

https://lnkd.in/en93-vJ2

#505B2
#Repurposing
#fdaapproval

Discover the interview between stijn van rompay, CEO de Hyloris Pharmaceuticals and the journalist Juliette Badina✏️in the magazine Pharmaceutiques published in November 2023.

https://lnkd.in/eBP2h-e

Excited to be attending the Jefferies Healthcare Conference in London. stijn van rompay  , founder and CEO and Jean Luc Vandebroek, CFO will be there, looking forward seeing you all and have fruitful discussions!

#jefferieslondon

🤝 Join us in welcoming Monica C. to the team, who visited our headquarters in #Belgium for the first time this week! She takes on the role of #licensing manager, focusing on global out-licensing of our range of #repurposed and #reformulated product candidates. 
 
Monica has 2️⃣ 0️⃣  years of experience in commercial roles in the pharmaceutical industry - most recently as a commercial director in her home country #Spain.

Leer alles over #Hyloris in #Gent volgende week dinsdag 14 november 👉 om 19u presenteert onze CEO op het #Biotech XL-event van de Vlaamse Federatie van Beleggers - VFB.

U kan erbij zijn in de Campus #Kantienberg van de Arteveldehogeschool - of de presentatie volgen via de #livestream bij u thuis. Aansluitend volgt een vraag- en antwoordsessie en - voor alle aanwezigen in de aula - een gratis consumptie.

Inschrijven kan via deze link!

https://lnkd.in/e3xqruUm

📢 Hyloris Announces Out-Licensing of Atomoxetine Oral Liquid (targeting #ADHD) in #Canada

🔴 Territorial #expansion for a product candidate previously exclusively targeting the U.S.

🔴 KYE Pharmaceuticals to register and #commercialize the product candidate in Canada, regulatory submission targeted in 2024

stijn van rompay, chief executive officer of Hyloris: “𝘞𝘦 𝘢𝘳𝘦 𝘱𝘳𝘰𝘶𝘥𝘭𝘺 𝘱𝘢𝘳𝘵𝘯𝘦𝘳𝘪𝘯𝘨 𝘸𝘪𝘵𝘩 𝘵𝘩𝘪𝘴 𝘭𝘰𝘤𝘢𝘭 𝘤𝘩𝘢𝘮𝘱𝘪𝘰𝘯 𝘧𝘰𝘤𝘶𝘴𝘦𝘥 𝘰𝘯 𝘤𝘰𝘮𝘮𝘦𝘳𝘤𝘪𝘢𝘭𝘪𝘻𝘪𝘯𝘨 𝘵𝘩𝘦𝘳𝘢𝘱𝘪𝘦𝘴 𝘸𝘪𝘵𝘩𝘪𝘯 𝘱𝘦𝘥𝘪𝘢𝘵𝘳𝘪𝘤𝘴 𝘢𝘯𝘥 𝘯𝘦𝘶𝘳𝘰𝘴𝘤𝘪𝘦𝘯𝘤𝘦𝘴. 𝘗𝘢𝘳𝘵𝘯𝘦𝘳𝘪𝘯𝘨 𝘢𝘵𝘰𝘮𝘰𝘹𝘦𝘵𝘪𝘯𝘦 𝘰𝘳𝘢𝘭 𝘭𝘪𝘲𝘶𝘪𝘥 𝘰𝘶𝘵𝘴𝘪𝘥𝘦 𝘰𝘧 𝘵𝘩𝘦 𝘜.𝘚. 𝘶𝘯𝘥𝘦𝘳𝘭𝘪𝘯𝘦𝘴 𝘰𝘶𝘳 𝘤𝘢𝘱𝘢𝘣𝘪𝘭𝘪𝘵𝘺 𝘵𝘰 𝘣𝘳𝘪𝘯𝘨 𝘪𝘯𝘯𝘰𝘷𝘢𝘵𝘪𝘷𝘦 𝘵𝘳𝘦𝘢𝘵𝘮𝘦𝘯𝘵𝘴 𝘵𝘰 𝘱𝘢𝘵𝘪𝘦𝘯𝘵𝘴 𝘰𝘯 𝘢 𝘨𝘭𝘰𝘣𝘢𝘭 𝘴𝘤𝘢𝘭𝘦, 𝘢𝘯𝘥 𝘶𝘯𝘭𝘰𝘤𝘬 𝘵𝘩𝘦 𝘩𝘪𝘥𝘥𝘦𝘯 𝘷𝘢𝘭𝘶𝘦 𝘪𝘯 𝘰𝘶𝘳 𝘦𝘹𝘪𝘴𝘵𝘪𝘯𝘨 𝘱𝘪𝘱𝘦𝘭𝘪𝘯𝘦 𝘰𝘧 𝘳𝘦𝘧𝘰𝘳𝘮𝘶𝘭𝘢𝘵𝘦𝘥 𝘢𝘯𝘥 𝘳𝘦𝘱𝘶𝘳𝘱𝘰𝘴𝘦𝘥 𝘱𝘳𝘰𝘥𝘶𝘤𝘵 𝘤𝘢𝘯𝘥𝘪𝘥𝘢𝘵𝘦𝘴.”

John McKendry, president of Kye: “𝘔𝘢𝘯𝘺 𝘊𝘢𝘯𝘢𝘥𝘪𝘢𝘯𝘴 𝘸𝘪𝘵𝘩 𝘈𝘋𝘏𝘋 𝘢𝘳𝘦 𝘶𝘯𝘢𝘣𝘭𝘦 𝘵𝘰 𝘵𝘢𝘬𝘦 𝘴𝘰𝘭𝘪𝘥 𝘵𝘢𝘣𝘭𝘦𝘵𝘴 𝘢𝘴 𝘱𝘳𝘦𝘴𝘤𝘳𝘪𝘣𝘦𝘥, 𝘢𝘯𝘥 𝘢𝘭𝘵𝘦𝘳𝘯𝘢𝘵𝘪𝘷𝘦 𝘧𝘰𝘳𝘮𝘶𝘭𝘢𝘵𝘪𝘰𝘯𝘴 𝘸𝘩𝘪𝘤𝘩 𝘩𝘢𝘷𝘦 𝘣𝘦𝘦𝘯 𝘢𝘷𝘢𝘪𝘭𝘢𝘣𝘭𝘦 𝘪𝘯𝘵𝘦𝘳𝘯𝘢𝘵𝘪𝘰𝘯𝘢𝘭𝘭𝘺 𝘢𝘳𝘦 𝘯𝘰𝘵 𝘳𝘦𝘢𝘥𝘪𝘭𝘺 𝘢𝘷𝘢𝘪𝘭𝘢𝘣𝘭𝘦 𝘪𝘯 𝘵𝘩𝘦 𝘊𝘢𝘯𝘢𝘥𝘪𝘢𝘯 𝘮𝘢𝘳𝘬𝘦𝘵. 𝘛𝘩𝘪𝘴 𝘱𝘢𝘳𝘵𝘯𝘦𝘳𝘴𝘩𝘪𝘱 𝘦𝘹𝘱𝘢𝘯𝘥𝘴 𝘰𝘶𝘳 𝘨𝘳𝘰𝘸𝘪𝘯𝘨 𝘱𝘰𝘳𝘵𝘧𝘰𝘭𝘪𝘰 𝘰𝘧 𝘪𝘯𝘯𝘰𝘷𝘢𝘵𝘪𝘷𝘦 𝘈𝘋𝘏𝘋 𝘵𝘳𝘦𝘢𝘵𝘮𝘦𝘯𝘵𝘴 𝘢𝘯𝘥 𝘸𝘪𝘭𝘭 𝘦𝘯𝘴𝘶𝘳𝘦 𝘊𝘢𝘯𝘢𝘥𝘪𝘢𝘯 𝘱𝘢𝘵𝘪𝘦𝘯𝘵𝘴 𝘩𝘢𝘷𝘦 𝘢𝘤𝘤𝘦𝘴𝘴 𝘵𝘰 𝘢 𝘭𝘪𝘲𝘶𝘪𝘥 𝘧𝘰𝘳𝘮𝘶𝘭𝘢𝘵𝘪𝘰𝘯 𝘰𝘧 𝘢𝘵𝘰𝘮𝘰𝘹𝘦𝘵𝘪𝘯𝘦, 𝘢 𝘸𝘦𝘭𝘭-𝘦𝘴𝘵𝘢𝘣𝘭𝘪𝘴𝘩𝘦𝘥 𝘯𝘰𝘯-𝘴𝘵𝘪𝘮𝘶𝘭𝘢𝘯𝘵 𝘮𝘦𝘥𝘪𝘤𝘢𝘵𝘪𝘰𝘯.”

Read the full announcement: https://lnkd.in/ek9ean2u

#reformulation #505B2 #unmetmedicalneeds

👋 Welcome to our R&D lab in Liège 👇

We were featured on Belgian business TV Trends Kanaal Z after our non-opioid pain treatment, Maxigesic IV, was approved for the U.S. market earlier this week.

💉  We're hoping to help reduce the use of addictive opioid #painkillers in post-operative patients by offering this new synergistic, highly potent combination of #Paracetamol IV and #Ibuprofen IV.

In the meantime, our colleagues in the lab are working on the next innovative medicines where we focus on improving patient outcomes by #reformulating and #repurposing existing, known molecules.

#hyloris Kris Vera #pharmaceuticals #505b2

📢 U.S. #FDA approval for #Maxigesic IV, a potent non-opioid #painkiller 📢 

“𝘉𝘳𝘪𝘯𝘨𝘪𝘯𝘨 𝘪𝘯𝘯𝘰𝘷𝘢𝘵𝘪𝘰𝘯 𝘣𝘺 #𝘳𝘦𝘧𝘰𝘳𝘮𝘶𝘭𝘢𝘵𝘪𝘯𝘨 𝘦𝘹𝘪𝘴𝘵𝘪𝘯𝘨 #𝘮𝘦𝘥𝘪𝘤𝘪𝘯𝘦𝘴 𝘩𝘪𝘨𝘩𝘭𝘪𝘨𝘩𝘵𝘴 𝘩𝘰𝘸 𝘏𝘺𝘭𝘰𝘳𝘪𝘴 𝘤𝘢𝘯 𝘪𝘮𝘱𝘳𝘰𝘷𝘦 #𝘱𝘢𝘵𝘪𝘦𝘯𝘵 𝘰𝘶𝘵𝘤𝘰𝘮𝘦𝘴, 𝘴𝘱𝘦𝘤𝘪𝘧𝘪𝘤𝘢𝘭𝘭𝘺 𝘣𝘺 𝘢𝘥𝘥𝘳𝘦𝘴𝘴𝘪𝘯𝘨 𝘵𝘩𝘦 𝘥𝘦𝘷𝘢𝘴𝘵𝘢𝘵𝘪𝘯𝘨 #𝘰𝘱𝘪𝘰𝘪𝘥 𝘤𝘳𝘪𝘴𝘪𝘴 𝘪𝘯 𝘵𝘩𝘦 𝘣𝘪𝘨𝘨𝘦𝘴𝘵 𝘩𝘦𝘢𝘭𝘵𝘩 𝘤𝘢𝘳𝘦 𝘮𝘢𝘳𝘬𝘦𝘵 𝘪𝘯 𝘵𝘩𝘦 𝘸𝘰𝘳𝘭𝘥,” said our CEO, co-founder and biggest shareholder, stijn van rompay.

“𝘔𝘢𝘹𝘪𝘨𝘦𝘴𝘪𝘤® 𝘐𝘝 𝘥𝘦𝘮𝘰𝘯𝘴𝘵𝘳𝘢𝘵𝘦𝘴 𝘵𝘩𝘦 𝘱𝘰𝘵𝘦𝘯𝘵𝘪𝘢𝘭 𝘰𝘧 𝘰𝘶𝘳 𝘴𝘵𝘳𝘢𝘵𝘦𝘨𝘺 𝘰𝘧 𝘣𝘳𝘪𝘯𝘨𝘪𝘯𝘨 𝘱𝘳𝘰𝘥𝘶𝘤𝘵 𝘤𝘢𝘯𝘥𝘪𝘥𝘢𝘵𝘦𝘴 𝘵𝘰 𝘮𝘢𝘳𝘬𝘦𝘵 𝘸𝘪𝘵𝘩𝘪𝘯 𝘰𝘶𝘳 𝘴𝘵𝘳𝘪𝘤𝘵 𝘤𝘳𝘪𝘵𝘦𝘳𝘪𝘢: 𝘢 𝘥𝘦𝘷𝘦𝘭𝘰𝘱𝘮𝘦𝘯𝘵 𝘰𝘧 7 𝘺𝘦𝘢𝘳𝘴 𝘰𝘳 𝘭𝘦𝘴𝘴, 𝘢𝘯𝘥 𝘙&𝘋 𝘤𝘰𝘴𝘵𝘴 𝘢𝘷𝘦𝘳𝘢𝘨𝘪𝘯𝘨 𝘭𝘦𝘴𝘴 𝘵𝘩𝘢𝘯 𝘌𝘜𝘙 7 𝘮𝘪𝘭𝘭𝘪𝘰𝘯.”

📰 Read the full announcement here: https://lnkd.in/exMiFHd5 

#pharmaceuticals #505b2 #fda #approval

We’re #hiring. Know anyone who might be interested?

👩⚕️ Enthusiastic about #patent protection and #science? We would like to hear from you!

Check out our latest #job opening below, and find even more opportunities on our #career website.

Contact details are included at the bottom of the PDF, so please reach out!

#ip #intellectualproperty #pharmaceuticaljobs

🙌 We are proud and happy to welcome Mohini Jadhav to the team, as she takes on the role of Business Development Coordinator! Ms. Mohini has degrees in #pharmacy and #management studies with a specialization in #marketing, and brings almost 5 years of experience in out-licensing of #pharmaceutical products.

#outlicensing #hyloris
#repurposing #reformulating #505b2

	Dec '17	Dec '18	Dec '19	Dec '20	Dec '21	Dec '22	Dec '23
revenue	213K -	91K 57.28%	91K 0%	175K 92.31%	3.10M 1,669.14%	2.95M 4.68%	2.81M 4.64%
cost of revenue	95K -	65K 31.58%	66K 1.54%	145K 119.70%	107K 26.21%	94K 12.15%	442K 370.21%
gross profit	118K -	26K 77.97%	25K 3.85%	30K 20%	2.99M 9,863.33%	2.86M 4.42%	2.37M 16.98%
selling and marketing expenses
general and administrative expenses	1.66M -	622K 62.46%	808K 29.90%	2.19M 171.53%	2.90M 32.18%	3.52M 21.28%
selling general and administrative expenses	1.66M -	622K 62.46%	808K 29.90%	2.19M 171.53%	2.90M 32.18%	3.52M 21.28%	5.30M 50.81%
research and development expenses	2.31M -	4.87M 110.55%	4.58M 6.02%	3.41M 25.43%	5.06M 48.14%	10.15M 100.77%	14.75M 45.30%
other expenses	13K -	3K 76.92%	-86K 2,966.67%	-1.47M 1,606.98%	5.38M 466.55%	-303K 105.63%
cost and expenses	4.08M -	5.56M 36.34%	5.37M 3.51%	5.75M 7.21%	13.44M 133.73%	13.46M 0.11%	20.50M 52.28%
operating expenses	3.98M -	5.50M 37.96%	5.30M 3.57%	5.61M 5.81%	13.34M 137.86%	13.37M 0.21%	20.05M 50.04%
interest expense	146K -	340K 132.88%	411K 20.88%	992K 141.36%	556K 43.95%	219K 60.61%	393K 79.45%
ebitda	-3.57M -	-5.63M 57.64%	-2.06M 63.33%	-5.67M 174.77%	-10.59M 86.62%	-10.22M 3.44%	-17.33M 69.51%
operating income	-3.87M -	-5.47M 41.46%	-5.27M 3.57%	-5.58M 5.75%	-10.35M 85.55%	-10.51M 1.55%	-17.68M 68.26%
depreciation and amortization	65K -	88K 35.38%	3.21M 3,546.59%	-97K 103.02%	-241K 148.45%	283K 217.43%	349K 23.32%
total other income expenses net	82K -	-590K 819.51%	-508K 13.90%	-1.57M 208.66%	-934K 40.43%	-258K 72.38%	2.07M 900.78%
income before tax	-3.78M -	-6.06M 60.16%	-5.78M 4.57%	-7.14M 23.57%	-11.28M 57.90%	-10.77M 4.57%	-15.62M 45.04%
income tax expense	-66K -	-20K 69.70%	-14K 30%	1K 107.14%	297K 29,600%	4K 98.65%	147K 3,575%
net income	-3.72M -	-5.79M 55.80%	-5.77M 0.40%	-7.15M 23.89%	-11.58M 62.03%	-10.77M 6.99%	-15.76M 46.35%
weighted average shs out	23.55M -	23.55M 0%	5M 78.77%	25.83M 416.65%	25.83M 0%	27.20M 5.29%	28.15M 3.48%
weighted average shs out dil	23.55M -	23.55M 0%	5M 78.77%	25.83M 416.65%	25.83M 0%	27.20M 5.29%	28.15M 3.48%
eps	-0.16 -	-0.25 56.25%	-1.15 360.00%	-0.28 75.65%	-0.45 60.71%	-0.40 11.11%	-0.56 40.00%
epsdiluted	-0.16 -	-0.25 56.25%	-1.15 360.00%	-0.28 75.65%	-0.45 60.71%	-0.40 11.11%	-0.56 40.00%

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Hyloris Pharmaceuticals

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