On April 12, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported financial results and corporate updates for the fiscal year ended 31 December 2021 (Press release, Evotec, APR 12, 2022, View Source [SID1234612024]).

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FINANCIALS REFLECT GREAT PERFORMANCE
Group revenues significantly exceeded the revenue target, up 23% to € 618.0 m (+27% like for like, excluding portfolio and fx effects (2020: € 500.9 m))
Base business up 18% (20% adjusted for Sanofi payment in Q1 2020)
Adjusted Group EBITDA in line with guidance at € 107.3 m, up 1% (2020: € 106.7 m); like-for-like growth up 18%
Unpartnered R&D expenses of € 58.1 m (2020: € 46.4 m up 25%)
Very strong liquidity position with € 858.2 m in cash

GREAT PROGRESS ACROSS ALL "BUILDING BLOCKS" OF ACTION PLAN 2025
Multiple new and extended integrated drug discovery, development, and manufacturing alliances
Important clinical trial initiations and significant progress in co-owned pipeline
Excellent progress in iPSC and protein degradation collaborations with Bristol Myers Squibb; Opt-in for EVT8683 and start of clinical development
New EVT Innovate partnerships e.g. in heart failure, kidney disease, RNA-based drug discovery, oncology, etc.
Acceleration & initiation of innovative platforms, tools & technologies – EVOcells, EVOpanOmics, EVOpanHunter, E.INVENT.AI, E.SOLVE, E.RNA, etc.
Launch of three new BRIDGEs, the pandemic preparedness initiative PRROTECT as well as E.MPD, the largest and highest quality molecular patient database (after period-end)
Excellent progress within operational venturing strategy, including Exscientia IPO on NASDAQ
CORPORATE HIGHLIGHTS
Secondary listing on NASDAQ with public offering raising gross proceeds of $ 500 m
Opening of J.POD Redmond, WA (US); initiation of J.POD Toulouse, France (EU)
Expansion of footprint with the acquisition of land and buildings of Verona (Italy) site from GlaxoSmithKline SpA, now "Campus Levi-Montalcini"; Sustainable expansion of "Dorothy Crowfoot Hodgkin Campus" in Abingdon (UK); Relocation of Munich site to Campus Neuried (after period-end)
Dr Matthias Evers joins Evotec as Chief Business Officer (effective 1st May 2022)
FINANCIAL GUIDANCE 2022 – CONTINUED STRONG GROWTH
Group revenues expected to be in a range of € 700 – 720 m (€ 690 – 710 m at constant exchange rates) (2021: € 618.0 m)
Unpartnered research and development expenses expected to be in a range of € 70 – 80 m (2021: € 58.1 m)
Adjusted Group EBITDA expected to be in the range of € 105 – 120 m (€ 95 – 110 m at constant exchange rates) (2021: € 107.3 m)
 

FINANCIALS REFLECT STRONG GROWTH
In 2021, Evotec’s group revenues increased by 23% to € 618.0 m (+27% like for like, excluding portfolio and fx effects) (2020: € 500.9 m), in a market that saw disruptions caused by the COVID-19 pandemic. Like-for-like growth is adjusted for the end of the Sanofi payment after Q1 2020 (€ (8.6) m) and negative foreign exchange effects (€ (9.2) m) in 2021. The positive development was mainly due to the continued robust performance of the base business in all areas as well as higher milestone payments. Due to great progress within both existing and new partnerships (e.g. with Bristol Myers Squibb ("BMS") in neuroscience and with Takeda in RNA-targeting small molecules), revenues from upfront, milestone and licence payments were significantly higher than in the previous year (2020: € 30.1 m) at € 61.3 m. Additionally, fiscal year 2021 benefited from an increased revenue contribution by Just – Evotec Biologics of € 53.6 m (2020: € 41.1 m).

In 2021, Evotec substantially increased its unpartnered R&D expenses of € 58.1 m (2020: € 46.4 m) in order to further accelerate the development of its efficiency and precision medicine platforms as well as the development of new first-in-class drug candidates. Its partnered R&D expenses declined to € 14.1 m (2020: € 17.5 m). "Partnered" are funded projects and are mainly run at the ID Lyon site, which was acquired in 2018.

In 2021, the group’s selling, general and administrative ("SG&A") expenses increased by 37% to € 105.4 m (2020: € 77.2 m), mainly as a result of an increase of the headcount in preparation for future growth as well as NASDAQ listing-related expenses for consulting and legal services as well as higher insurance premiums. One-off expenses for the US listing and other strategic activities amounted to approximately € 1.7 m.

Adjusted Group EBITDA increased to € 107.3 m in 2021 (+1% and + 18% like for like) (2020: € 106.6 m), despite significant expenditures into R&D as well as higher COGS and SG&A expenses ahead of the manufacturing start at J.POD Redmond, WA (US). The increase was mainly due to higher base business, increasing revenues from milestone payments, and favourable R&D tax credits in Italy and France.

Evotec recorded an operating result for 2021 of € 41.0 m (2020: € 48.5 m), due to the reasons mentioned above as well as higher depreciations after completion of the J.POD facility in Redmond, WA (US). With € 215.5 m, the Company’s net income was significantly higher than in the previous year (2020: € 6.3 m). This increase was mainly due to an adjustment to the fair value of Evotec’s stake in Exscientia Ltd. following Exscientia’s IPO in the US.

With the liquidity increase following Evotec’s own public offering on NASDAQ, the net debt ratio at 31 December 2021 (excl. IFRS16) improved to a net cash position of (negative) 5.5x adjusted Group EBITDA (2020: (negative) 1.5x adjusted Group EBITDA) with a net cash position of € 494.3 m and a significantly increased equity ratio of 61.6% (2020: 49.4%).

STRONG PERFORMANCE ACROSS ALL BUSINESS SEGMENTS
EVT Innovate was characterised in 2021 by multiple important clinical trial initiations, an acceleration of the milestone income from its strategic partnerships (e.g. iPSC neuroscience and targeted protein degradation collaborations with BMS as well as the signing of multiple new partnerships e.g., with Takeda in RNA-based drug discovery, with Chinook Therapeutics in chronic kidney diseases, and with Medical Center Hamburg-Eppendorf in heart failure.

In the course of 2021, notable achievements were obtained within Evotec’s strategic partnerships with BMS. BMS exercised a licensing option for EVT8683 and moved the compound into a first clinical Phase I trial shortly thereafter. The opt-in decision by BMS led to a payment of $ 20 m to Evotec. Moreover, the inclusion of a new cell type and additional programme designations triggered payments of more than $ 50 m to Evotec.

In 2021 we also saw several other pipeline assets added to the list of drug candidates in clinical trials: In January 2021, the chikungunya virus antibody EVT894 entered Phase I of clinical development. The immuno-oncology project A2a receptor antagonist in cooperation with Exscientia reached Phase I. Also, Evotec’s oncology agent EVT801 developed in cooperation with Kazia Therapeutics entered clinical development.

In autumn 2021 Bayer’s drug candidate eliapixant (BAY1817080) showed positive Phase IIb results in refractory chronic cough. However, at the beginning of February of 2022 (after period-end), Bayer informed Evotec about its decision to discontinue the development of the investigational P2X3 receptor antagonist eliapixant (BAY1817080). As a consequence of Bayer’s decision, Evotec has the possibility to regain the rights to all P2X3 assets. The Company will evaluate the underlying data and all options.

In 2021, Evotec’s academic BRIDGE model was accelerated through the launch of three new BRIDGE partnerships. In April and May of 2021, beLAB2122, beLAB1407 were launched, each backed by Bristol Myers Squibb with a total funding volume of $ 20 m each. June 2021 saw the launch of Danube Labs, a BRIDGE partnership with CEBINA GmbH to identify and develop academic projects from Central and Eastern Europe into mature therapeutic product development opportunities. The Company made a new investment in the promising Biotech company OxVax that is based on research from Oxford University, and participated in several financing rounds and successful spin-offs, such as Topas Therapeutics, Celmatix and CureXsys. In October of 2021, Exscientia Ltd., in which Evotec has a significant stake, successfully completed an IPO on NASDAQ.

Evotec also made significant progress towards building the globally leading precision medicine platform by accelerating and initiating innovative platforms, tools, and technologies such as EVOcells, EVOpanOmics, EVOpanHunter, E.INVENT.AI, E.SOLVE, E.RNA, etc. At the start of 2022, to leverage the power of molecular data, Evotec launched its molecular patient database (E.MPD). E.MPD is one of the largest and highest quality molecular databases globally.

The EVT Execute segment continued to demonstrate strong progress in 2021 with new and extended alliances. In 2021, Evotec was involved in 842 alliances and recorded a repeat business of 91%. Evotec signed new and extended existing partnerships and alliances, e.g. with Abivax, Annexon, Awakn, 1st Biotherapeutics, Bicycle Therapeutics, EQRx, Evommune, Interline, Related Sciences, Takeda. Just – Evotec Biologics continued its strong growth by continuing the collaboration with the US Department of Defense, and introducing the humanoid antibody library J.HAL℠ to the market.

J.POD REDMOND, WA (US) OPEN FOR BUSINESS, J.POD TOULOUSE, FRANCE (EU) INITIATED
In August 2021, Evotec opened its late-stage clinical and commercial biologics current Good Manufacturing Practice ("cGMP") manufacturing facility, J.POD Redmond WA, (US). The innovative 130,000 square foot cGMP biomanufacturing facility was designed with improved environmental sustainability and a significant compressed construction time compared to traditional biologics manufacturing. Additionally, the design and planning of a second J.POD facility in Europe has been initiated. The build-up of J.POD Toulouse, France (EU) will be supported by the French government, the Occitanie Region, Bpifrance, the Haute-Garonne prefecture as well as the Toulouse Métropole. J.POD Toulouse, France (EU) is expected to be fully operational in 2024.

Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: "2021 was another very successful year for Evotec, making it the tenth consecutive year of double-digit growth. Our profitable base business gives us the opportunity to reinvest returns into our data-driven platforms, to enter a sustainable growth pattern. Based on our core principles of leveraging data, artificial intelligence and human disease models to improve probabilities of success, Evotec is in an ideal position to drive and thrive as the industry paradigm shifts to effective precision medicines of the future."

FINANCIAL GUIDANCE 2022 – ACCELERATING SUSTAINABLE GROWTH
In 2022, Evotec expects Group revenues to grow in a range of € 700 – 720 m. At unchanged exchange rates compared to 2021, this range is € 690 – 710 m. This assumption is based on current orders on hand, foreseeable new contracts and the extension of contracts as well as prospective milestone payments as well as the current status of the main foreign currency exchange rates (especially US$; GBP). Furthermore, the forecast takes into account – as far as possible – the current global uncertainties related to the COVID-19 pandemic.

Evotec expects to achieve a stable adjusted Group EBITDA in the range of € 105 – 120 m. This projection takes account of increasing expenses for promising R&D projects, continued expansion of capacity and adoption of organisation structures to ensure sustainable growth, the ramp-up of the Just – Evotec Biologics business via investments, the further expansion of the J.POD capacities in the US and the construction of a second J.POD in Toulouse, France.

Evotec’s activities are all related to research and development ("R&D"). Aside from the partnered and funded R&D, Evotec will continue to strongly invest in its own unpartnered R&D to further expand its long-term and sustainable pipeline of first-in-class projects and platforms. Evotec expects unpartnered R&D investments in this area between € 70 and 80 m in 2022. Revenues, Unpartnered R&D expenses, and adjusted EBITDA remain the financial key performance indicators of the Evotec Group.

Download
The full annual report 2021 as well as the sustainability report 2021 will be available for download on April 26.

Webcast/Conference Call
The Company is holding a conference call to discuss the results as well as to provide an update on its performance. The conference call will be held in English.

A simultaneous slide presentation for participants dialling in via phone is available at View Source

Webcast details

To join the audio webcast and to access the presentation slides you will find a link on our homepage shortly before the event.

The on-demand version of the webcast will be available on our website: View Source

On April 12, 2022 Chimeric Therapeutics (ASX:CHM, "Chimeric") a clinical-stage cell therapy company and an Australian leader in cell therapy, reported that it has entered into a strategic manufacturing partnership with WuXi ATU, a global contract testing and manufacturing organization (CTDMO) (Press release, Chimeric Therapeutics, APR 12, 2022, View Source [SID1234611978]).

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The partnership initially focusses on Chimeric’s two autologous CAR T-cell therapies for solid tumours: CHM 2101 (CDH17 CAR T), currently in late preclinical development for gastrointestinal (GI) cancers and CHM 1101 (CLTX CAR T), currently being evaluated in a single-site phase 1 clinical trial for patients with recurrent or progressive glioblastoma.

CHM 2101 will leverage WuXi ATU’s end-to-end closed loop CAR T process development, Good Manufacturing Practice (GMP) manufacturing and testing platform, aiming to accelerate development towards its planned first-in-human study.

CHM 1101 will leverage WuXi ATU’s scalable manufacturing and analytical testing capacity to enable potential future expansion of the program to multiple additional clinical trial sites and additional solid tumour indications, including metastatic melanoma.

"We are very excited to enter into this partnership with WuXi ATU," said Jennifer Chow, CEO of Chimeric Therapeutics. "With its extensive experience in cGMP manufacturing and analytical testing, as well as its seamless platform process for CAR T-cell production, WuXi ATU is uniquely positioned to support the acceleration and expansion of the CHM 1101 and CHM 2101 development programs."

Dr David Chang, CEO of WuXi Advanced Therapies, added, "We’re delighted to partner with Chimeric Therapeutics to accelerate the development of two of their autologous CAR T cell programs. These treatments offer much needed hope to patients with gastrointestinal cancers or glioblastoma, and we are honoured to support Chimeric Therapeutics as they prepare these treatments for further clinical testing."

This partnership will enable Chimeric to accelerate clinical manufacturing readiness for new CAR T assets and to scale CAR T manufacturing to support multiple, simultaneous, multi-center CAR T clinical trials in the future.

On April 12, 2022 Engitix Ltd (‘Engitix’), a biotechnology company developing a portfolio of programmes in fibrosis and solid tumours using its proprietary human extracellular matrix (ECM) platform, reported that entered into an agreement with Takeda to expand an existing collaboration to now include the discovery and development of novel therapeutics for fibrostenotic inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis (Press release, Engitix, APR 12, 2022, View Source [SID1234611971]).

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Under the terms of this agreement, Engitix and Takeda will collaborate in the confirmation and validation of targets and the preclinical development of therapeutics in IBD using Engitix’s unique extracellular matrix (ECM) discovery platform.

Takeda will have exclusive rights to develop and commercialise certain clinical candidates generated against validated targets arising from the collaboration. Engitix will receive an upfront payment, with additional near-term payments based on the confirmation and functional validation of selected targets. Engitix will be eligible to receive a total of up to approximately $300 million for the achievement of preclinical, development, regulatory and commercial milestones over the course of the partnership, as well as further royalty payments based on sales of commercialised products. This agreement builds on the collaboration between the companies announced in mid-2020 for the discovery and development of novel therapeutics for advanced fibrotic liver diseases, including non-alcoholic steatohepatitis (NASH).

Dr Giuseppe Mazza, Co-Founder and CEO of Engitix, commented: "We are delighted that based on positive progress in our existing R&D partnership in liver diseases, Takeda has extended the scope of the drug discovery collaboration to now include fibrostenotic IBD. It underlines the value they see in using our ECM platform and the successful co-operation we have established. ECM remodelling plays a key role in driving IBD pathogenesis forward and targeting this process in a specific and fine-tuned manner may contribute to the treatment of IBD by preventing both propagated inflammation, fibrosis and stricturing disease."

By incorporating tissue- and disease-specific human ECM from our extensive biobank of human tissues into in vitro models Engitix’s platform preserves the natural cell microenvironment offering the unique capability of understanding the bioactive role of human ECM in modulating disease progression in fibrosis and solid tumours. By more accurately predicting disease drivers in human samples including our proprietary bioinformatic tools, the platform has the potential to accelerate discovery and reduce late-stage clinical failures.

Dr Gareth Hicks, Head of the GI Drug Discovery Unit at Takeda, added: "Partnerships are central to our R&D strategy, forming collaborations anchored around novel scientific approaches in disease areas where patients’ needs are greatest. Engitix’s ECM platform will help accelerate the identification and validation of novel targets that will be valuable in our search for better therapies for all those affected by GI and liver diseases."

Fibrostenosis is intestinal inflammation-driven fibrotic obstruction, most commonly seen in the Crohn’s disease (CD) category of IBD. Some 0.8% of the population of Western advanced countries are estimated to have IBD, with this forecast to rise to over 1% by 2030. There is no cure for IBD and the rates of primary and secondary treatment failure among current therapies is high. Fibrostenotic CD patients in particular have high disease burden; stricture-induced intestinal obstruction is the most common indication for surgery within CD, with up to 70% of fibrostenotic CD patients requiring multiple surgical procedures. There is currently no clinical treatment for intestinal fibrosis pathology in IBDs. Thus, a significant unmet need remains for this population of patients to have therapies which alter their disease course.

On April 11, 2022 Recursion (NASDAQ: RXRX), the clinical-stage biotechnology company industrializing drug discovery by decoding biology, reported that the U.S. Food and Drug Administration (FDA) has granted the company Fast Track designation for REC-4881 for the potential treatment of familial adenomatous polyposis (FAP) in patients who have previously undergone a colectomy/proctocolectomy (Press release, Recursion Pharmaceuticals, APR 11, 2022, View Source [SID1234617988]). REC-4881 is an orally bioavailable, non-ATP-competitive allosteric small molecule inhibitor of MEK1 and MEK2 being developed to reduce polyp burden and progression to adenocarcinoma in FAP patients.

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"The Fast Track designation for REC-4881 is an important addition to our work to rapidly develop this potential medicine to treat patients with FAP, for which there is significant unmet need," said Recursion Chief Medical Officer Ramona Doyle, M.D. "I am pleased that the team continues to advance this drug candidate towards a Phase 2 study to evaluate safety, pharmacokinetics and efficacy in FAP patients, for which we expect to begin enrolling patients in the third quarter of this year."

The FDA’s Fast Track designation was established to expedite the review of investigational drugs to treat serious conditions and address unmet medical needs by enabling important drugs to get to patients earlier if approved. Fast Track designation can lead to more frequent interactions with the FDA, as well as Accelerated Approval and/or Priority Review eligibility if certain criteria are met.

Learn more about Recursion and view its pipeline at Recursion.com/pipeline.

About REC-4881
REC-4881 is an orally bioavailable, non-ATP-competitive allosteric small molecule inhibitor of MEK1 and MEK2 being developed to reduce polyp burden and progression to adenocarcinoma in FAP patients. REC-4881 has been well tolerated in prior clinical studies, consistent with the intended use, and has a gut-localized PK-profile that may be advantageous for FAP, and potentially other APC-driven gastrointestinal tumors. REC-4881 has been granted Orphan Drug designation for FAP by the FDA. We expect to enroll the first patient in a Phase 2, double-blind, randomized, placebo-controlled basket trial in the third quarter of 2022.

About Familial Adenomatous Polyposis
FAP is a rare tumor syndrome with no approved therapies. In the US, France, Germany, Italy, Spain and the UK alone the disease affects approximately 50,000 patients. FAP is caused by autosomal dominant inactivating mutations in the tumor suppressor gene APC. FAP patients develop polyps in the gastrointestinal tract throughout their lives. These growths have a high risk of malignant transformation and can give rise to invasive cancers of the colon, stomach, duodenum, rectum, and other tissues. Standard of care for patients with FAP is colectomy, and without surgical intervention, affected patients will progress to colorectal cancer in adulthood. Even after colectomy, patients receive endoscopic surveillance every 6-12 months to monitor disease progression. While surgical management and surveillance have improved the prognosis for FAP patients, duodenal and desmoid tumors remain major causes of death following colectomy in patients with FAP.

On April 11, 2022 Circle Pharma, a pre-clinical stage company focused on developing macrocycle therapeutics against targets previously considered to be undruggable, reported that it will present a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held April 8-13, in New Orleans, Louisiana (Press release, Circle Pharma, APR 11, 2022, View Source [SID1234613861]).

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The Company’s presentation will provide details of its progress towards structure-guided macrocycles that inhibit the protein-protein interaction between the cyclin A:CDK2 complex and key substrates that are phosphorylated by this complex. Inhibition of Cyclin A substrate binding has been postulated to be synthetic lethal in Rb mutated cancers. The data presented include evidence that macrocycle inhibitors of cyclin A induce G2/M arrest and apoptosis in small cell lung cancer (SCLC) cell lines and have anti-tumor efficacy in SCLC xenograft animal models. Circle plans to advance its cyclin A inhibitor program to the clinic for testing in a range of cancer types, including SCLC where Rb mutations are highly prevalent.

The presentation will be made as part of the Mechanisms of Drug Action / Experimental and Molecular Therapeutics session at the AACR (Free AACR Whitepaper) meeting, Abstract No. 5379.