Adelis Equity Partners Fund I (“Adelis”) divests its majority stake in Nordentic, the largest dental labs Group in the Nordics, to Corus. Corus is a leading dental labs Group in Europe, with operations in France, Spain, the Netherlands, Belgium and Portugal.

Adelis invested in Nordentic in 2017, in partnership with the founders and key management of Nordentic, including the CEO, Johnny Tekin. During Adelis’ ownership, over 20 dental labs have come together as one Group, and as a pioneer in the technical development of the industry. By combining management’s deep industrial knowledge with strategic acquisitions and investments in lab technology, Nordentic has evolved as one of Europe’s leading dental labs Group, solely focusing on onshore/local production.

“Johnny, the rest of Nordentic’s management, and the lab managers have done a fantastic job transforming Nordentic as well as managing the company through the challenging times of Covid-19. We are proud of what we have achieved together and look forward to following Nordentic in its journey together with Corus”, say Hampus Nestius and Joel Russ at Adelis.

Thomas Berglund, Chairman of Nordentic says: “It has been an honor to work with the team of Nordentic. Through joint efforts, we have created a strong company for our customers, employees, and owners.”

“Adelis and our board of directors have been great partners to Nordentic, and I am very grateful for their contribution over the past years. They have been material in helping us set and deliver on the vision of Nordentic and have been a good speaking partner on both strategic and operational matters. I am very excited to join forces with Corus. We are both pioneers in the industry. I look forward to shaping the future of our industry together with them,” says Johnny Tekin, CEO of Nordentic.

The parties have agreed not to disclose the purchase price. The transaction is expected to close during Q3 2022.

Adelis was advised by Clearwater International, White & Case and Svalner on the transaction.

For further information:

Johnny Tekin, Nordentic, johnny.tekin@nordentic.com

Joel Russ, Adelis Equity Partners, joel.russ@adelisequity.com

Hampus Nestius, Adelis Equity Partners, hampus.nestius@adelisequity.com

About Nordentic

Nordentic is the leading dental lab company in Scandinavia with over 20 labs that have come together as one group since 2016. Nordentic has been a pioneer in the technical development of the industry. By combining management’s deep industrial knowledge with strategic acquisitions and investments in lab technology, Nordentic has evolved as one of Europe’s leading dental labs Group, solely focusing on onshore/local production.

About Adelis Equity Partners

Adelis is a growth partner for well-positioned, Nordic companies. Adelis partners with management and/or owners to build businesses in growth segments and with strong market positions. Since raising its first fund in 2013, Adelis has been one of the most active investors in the Nordic middle-market, making 35 platform investments and more than 150 add-on acquisitions. Adelis today manages approximately €2.5 billion in capital. For more information, please visit www.adelisequity.com.

FundamentalVR receives Series B growth investments to disrupt the medical simulation market – expected to be worth USD 4.2 billion by 2025.

FundamentalVR has raised USD 20 million to significantly accelerate medical skill-transfer and to increase surgical proficiency through its world-leading medical simulation platform, Fundamental Surgery.

The transaction was led by EQT Life Sciences, investing from the LSP Health Economics Fund 2, and joined by prior investors Downing Ventures. The new investments follows a Series A round from October 2019, and brings the company’s total funding to over USD 30 million.

FundamentalVR is the world’s first scalable medical simulation platform to combine virtual reality and haptics through data, artificial intelligence, and multimodal learning. FundamentalVR’s patented HapticVR™ technology mimics the physical touch of surgical actions which allows users to experience the sights, sounds, and physical sensations of real-life surgery. Scalable and hardware agnostic, the platform immerses users in a controlled training environment that lowers the surgical risk to patients.

Deployed in over 30 countries, FundamentalVR’s high-fidelity simulations helps life sciences, pharmaceutical and med-device companies deploy medical innovations in disciplines from ophthalmology, to robotics, gene therapy, and more. The growth investment will enable further development of HapticVR™, the machine learning data insights product, and geographic expansion throughout the US. FundamentalVR’s multiuser platform enables medical institutions, hospitals, and surgical educators, to scale professionally accredited surgical training throughout their organisations. Partnerships with hospital groups, including flagship clients and investors Mayo Clinic and Sana Kliniken, will drive further growth.

Richard Vincent, co-Founder and Chief Executive of FundamentalVR, said, “Our platform can conduct a walkthrough of a procedure through to a full operation, facilitating surgical skills transfer – which is why we have been enthusiastically embraced throughout the medical industry, from med-device manufacturers to pharmaceuticals. Our immersive environments transform surgical skills acquisition in a scalable, low-cost, multiuser way. We are excited to scale our vision of creating a medical education environment unhindered by borders.”

Drew Burdon, Partner at EQT Life Sciences, said, “With increasingly complex surgical procedures, it is important to provide medical professionals with new methods for surgical skills transfer and continued training and education, whilst managing both the cost and time burden associated with these activities. HapticVR™, is a differentiated approach which has already been adopted by a number of high-quality customers, in a short period of time, demonstrating the value that this system can add today”.

As part of the transaction, Drew Burdon will join the Board of Directors.

• First and only topical PDE4 inhibitor approved for the treatment of plaque psoriasis, including intertriginous psoriasis
• Approved for once-daily treatment in mild, moderate, and severe plaque psoriasis with no limitations on duration of use
• Established efficacy – provides rapid clearance of plaques and reduction of itch in all affected areas of the body
• Safe and very well-tolerated, steroid-free cream with minimal application site reactions
• Commercial product expected to be available by mid-August
• Management will host conference call on Monday, August 1 at 8:30 a.m. EDT
• Arcutis expects to draw an additional $125 million from the Company’s debt facility with SLR Capital Partners

WESTLAKE VILLAGE, Calif., July 29, 2022 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for ZORYVE (roflumilast) cream 0.3% for the treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age or older. The first and only topical phosphodiesterase-4 (PDE4) inhibitor approved for the treatment of plaque psoriasis, ZORYVE provides rapid clearance of psoriasis plaques and reduces itch in all affected areas of the body. ZORYVE — a once-daily, steroid-free cream in a safe and well tolerated, patient-friendly formulation — is uniquely formulated to simplify disease management for people living with plaque psoriasis.

“Today Arcutis has reached a major milestone, with our ability to offer this next generation topical PDE4 inhibitor to both adults and adolescents with plaque psoriasis. ZORYVE’s combination of efficacy, safety, and tolerability, coupled with our proprietary HydroARQ Technology formulation, is designed to fit into patients’ everyday lives with no restrictions on duration of use,” said Frank Watanabe, President and CEO of Arcutis. “Additionally, ZORYVE has been shown to rapidly clear plaques and reduce itch across all areas of the body. ZORYVE is the only topical for which data focused on the treatment of intertriginous plaques — a common area affected by plaque psoriasis — have been specifically generated. This FDA approval is the fruition of our efforts, and we are excited to launch ZORYVE, with expected product availability by mid-August.”

Topical therapies remain the primary treatment option for the vast majority of individuals with plaque psoriasis, a common immune-mediated skin disease that affects approximately nine million people in the U.S. and is the most frequent type of psoriasis occurring in both adults and adolescents. Severity can range between mild, moderate, and severe, with itch being the most burdensome and frequently reported symptom.

While the disease may affect any area of the body, plaques in certain areas, like the face, elbows and knees, genitalia, and intertriginous areas (areas of skin-to-skin contact), present unique treatment challenges. As a result, individuals with psoriasis are often prescribed multiple topical medications for different areas, which makes for a complicated treatment regimen.

“In multiple clinical trials, ZORYVE was proven to be safe and effective, with improvements in disease clearance in hard-to-treat areas like knees and elbows, as well as in sensitive areas such as the face, genitalia, and intertriginous areas. ZORYVE is very well tolerated, which is an important consideration for treating a chronic skin disease such as plaque psoriasis,” said Mark Lebwohl M.D., FAAD, principal investigator and Dean for Clinical Therapeutics and Chairman Emeritus of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai. “With this FDA approval, adults and adolescents with psoriasis and their dermatologists have a new steroid-free treatment option for use on all affected areas of the body.”

ZORYVE features HydroARQ Technology™, a proprietary drug delivery formulation that creates a non-greasy moisturizing cream that spreads easily and absorbs quickly.

“Plaque psoriasis is a challenging disease and finding the right treatment option can be complicated, especially if individuals have to use multiple treatments for different parts of their body. We welcome a new treatment option that can make a meaningful difference for adults and adolescents with plaque psoriasis,” says Leah M. Howard, President and CEO of the National Psoriasis Foundation. “Our hope is that new treatments translate into improved outcomes and help alleviate the burdens of chronic disease for people impacted by psoriasis.”

Arcutis intends to make ZORYVE widely available via key wholesaler and national dermatology pharmacy channels as a new treatment option by mid-August, and the Company is dedicated to affordable access to therapy. The ZORYVE Direct patient support program will help commercially insured individuals with plaque psoriasis get access and start ZORYVE treatment as prescribed by their healthcare provider quickly and easily by helping them navigate the payer process, lowering the out-of-pocket cost for eligible patients, and offering programs that support staying on therapy.^† Arcutis will also offer the Arcutis Cares patient assistance program (PAP) – the first of its kind for a topical psoriasis treatment – that will provide ZORYVE at no cost for financially eligible patients who are uninsured or underinsured.^‡

With this approval, Arcutis has access to, and plans to draw, an additional $125 million tranche as part of the Company’s non-dilutive financing agreement with SLR Capital Partners. Combined with the Company’s cash, cash equivalents, restricted cash, and marketable securities as of June 30, 2022, this additional $125 million will provide for capital resources of over $400 million to support the launch and commercialization efforts for ZORYVE, as well as continue to advance the Company’s pipeline development initiatives.

Management will host a conference call on Monday, August 1 at 8:30 a.m. EDT. Dial-in information for conference participants may be obtained by registering for the event here. A live webcast of the call and presentation material will be available on the “Events” section of the Company’s Investor website. An archived version of the webcast will be available on the Arcutis website after the call.

A Media Snippet accompanying this announcement is available by clicking on the image or link below:

ZORYVE Clinical Data

The approval is based on comprehensive results from the pivotal DERMIS-1 and DERMIS-2 (trials of PDE4 inhibition with Roflumilast for the Management of plaque psoriasIS One and Two) Phase 3 studies. In these trials, significantly more patients treated with ZORYVE achieved Investigator Global Assessment (IGA) success at Week 8 compared to vehicle (42% in DERMIS-1 and 37% in DERMIS-2 with ZORYVE compared to 6% in DERMIS-1 and 7% in DERMIS-2 with vehicle (P<0.0001 in both studies)). IGA success is defined as an IGA score of clear (0) or almost clear (1), plus a ≥2-grade IGA score improvement from baseline.

ZORYVE improved the severity and impact of itch, as early as Week 2. Two-thirds of patients with a Worst Itch-Numerical Rating Score (WI-NRS) of 4 or higher at baseline achieved a > 4-point reduction in itch at Week 8 with ZORYVE (67% vs. 26% in DERMIS-1 and 69% vs. 33% in DERMIS-2 at Week 8 (P<0.0001)).

ZORYVE is the only topical for which efficacy has been specifically demonstrated in the treatment of intertriginous psoriasis, as measured by Intertriginous IGA (I-IGA) Success (72% vs. 14% in DERMIS-1 and 68% vs. 17% in DERMIS-2 at Week 8 (P<0.0001)).

In both trials, ZORYVE was very well-tolerated with a favorable safety and tolerability profile. The most common adverse reactions reported in DERMIS-1 and -2 (≥1% of subjects treated with ZORYVE for 8 weeks), and for which the rate exceeded the rate for vehicle-treated patients, included diarrhea (3%), headache (2%), insomnia (1%), nausea (1%), application site pain (1%), upper respiratory tract infection (1%), and urinary tract infection (1%).

Of 239 individuals who continued treatment with ZORYVE for at least 52 weeks in an open-label long-term safety trial, 45% were evaluated as an IGA of “Clear” or “Almost Clear” at Week 52.

ZORYVE also demonstrated statistically significant improvements over vehicle on key secondary endpoints, including Psoriasis Area Severity Index-75 (PASI-75), and patient perceptions of signs and symptoms, such as itching, pain, and scaling, as measured by the Psoriasis Symptoms Diary (PSD). In both studies, ZORYVE improved overall signs and symptoms of psoriasis at Weeks 4 and 8 compared to vehicle.

Dr. Lebwohl reports receiving grant support and consulting fees from Arcutis Biotherapeutics.

About Psoriasis
Psoriasis is a common, non-contagious, immune-mediated skin disease that affects approximately nine million people in the United States. The majority of individuals with psoriasis develop “plaques,” or raised, red areas of skin covered with a silver or white layer of dead skin cells. The plaques’ clinical presentation may have more grayish, purplish, or brownish tones in people with darker skin tones. Psoriatic plaques are often itchy and sometimes painful and can appear on any area of the body. Plaques in certain anatomical areas present unique treatment challenges, including the face, elbows and knees, scalp, and intertriginous areas (where two skin areas may touch or rub together).

INDICATION

ZORYVE is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.

IMPORTANT SAFETY INFORMATION

The use of ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

The most common adverse reactions (≥1%) include diarrhea (3%), headache (2%), insomnia (1%), nausea (1%), application site pain (1%), upper respiratory tract infection (1%), and urinary tract infection (1%).

Please see full Prescribing Information.

About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis harnesses our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis’ dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions including plaque psoriasis, atopic dermatitis, and seborrheic dermatitis. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, and Twitter.

Forward-Looking Statements
Arcutis cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential for ZORYVE to simplify disease management for care of plaque psoriasis; the Company’s expected timing and plan to commercially launch ZORYVE by mid-August; and the Company’s plan to draw down on its loan agreement. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, conditions limiting our ability to access additional capital under our debt financing agreement, the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on February 22, 2022, as amended, as well as any subsequent filings with the SEC. You should not place undue reliance on any forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Contacts:

Media
Amanda Sheldon, Head of Corporate Communications
asheldon@arcutis.com

Investors
Eric McIntyre, Head of Investor Relations
emcintyre@arcutis.com

^{† *Uninsured patients and patients with government insurance are not eligible for the ZORYVE Direct savings program; Other terms and restrictions apply}

^{‡ Subject to financial eligibility requirements. Other terms and restrictions apply}