The demand for non-corona-induced medical and therapeutic measures has been increasing since mid-2021

In the first months of 2021 – due to the 3rd wave of the corona pandemic – there was still a low number of referrals from acute clinics and a reluctance to make use of rehabilitation services. This led only to a hesitant increase in occupancy in the first half of 2021. The occupancy has increased somewhat more clearly since the middle of the year.

Operating Group sales in the 1st half of 2021 above the previous year’s value, but still below the pre-Corona level

In the first half of 2021, MEDICLIN achieved Group sales of EUR 323.1 mill., which is EUR 0.4 mill. or 0.1% less than in the first half of 2020. At operating level, without benefits under the protective shield, Group sales increased by EUR 15.9 mill. or 5.4 % compared to the previous year’s period. Compared to 2019 before the coronavirus pandemic, sales without benefits under the protective shield are still EUR 25.3 mill. or 7.6 % below the sales generated in the first half of 2019.

As far as the Group operating result is concerned, at EUR -13.4 mill., it is EUR 4.6 mill. below the value of the first half of 2020 of EUR -8.8 mill. The result was impacted by an increase in raw materials and consumables used, mainly driven by higher demand and due to higher expenditure for hygiene and protective measures. Despite a decline in headcount, staff costs rose moderately.

As of June 30, 2021, cash and cash equivalents amounted to EUR 95.6 mill. (December 31, 2020: EUR 100.4 million). The cash and cash equivalents as of the balance sheet date include subsidies and expected reimbursements under the corona protective shield and other measures in the amount of around EUR 66.5 mill.

Outlook

Although the number of people infected with Corona has fallen continuously since the end of the 3rd wave respective the end of April 2021 – they are currently increasing again slightly – nevertheless, the sales and earnings development for the year as a whole depends on the further development of the number of infections and protective shield benefits. The protective shield benefits will be significantly lower for the year 2021″, comments Tino Fritz, CFO of MEDICLIN, on the expected further business development. MEDICLIN is currently assuming that capacity utilization at the level before Corona might not be achievable in the second half of 2021.

Reporting of the segments

In the post-acute segment, sales increased by EUR 4.2 mill. or 2.3%. Without taking protective shields benefits into account, sales increased by EUR 12.7 mill. or 7.4% in a half-year comparison.

The acute segment shows a decline in segment sales of EUR 5.1 million or 4.0%. Without protective shield services, sales rose by EUR 3.6 million or 3.1%. In the other activities segment, sales in the nursing care business area amounted to EUR 8.2 mill., EUR 0.4 mill. above the previous year’s figure.

Competence in post-COVID and long-COVID treatments

The interdisciplinary expertise that MEDICLIN has in the treatment of post-COVID and long-COVID patients is reflected in a significantly increasing demand. Pneumology experts work closely with experts in neurology, cardiology, psychiatry and psychosomatics.

Innovative concepts in rehabilitation

In addition to an offer for post-COVID and long-COVID patients, MEDICLIN is also increasingly taking care of other innovative concepts in rehabilitation. “It will be a particular challenge to adapt rehabilitation to changing demographic and social requirements with innovative performance-based concepts,” said Dr. York Dhein, Member of the Management Board of MEDICLIN and responsible for this business segment, and added: “MEDICLIN has shown that we can quickly build up and implement knowledge in our company in the treatment of post- and long-COVID patients.”

/

Über die MEDICLIN Aktiengesellschaft (Ticker: MED; WKN: 659 510)

Zu MEDICLIN gehören 35 Kliniken, sieben Pflegeeinrichtungen und zehn Medizinische Versorgungszentren. Die Gruppe verfügt über rund 8.350 Betten/Pflegeplätze und beschäftigt rund 10.200 Mitarbeiter. In einem starken Netzwerk bietet MEDICLIN dem Patienten die integrative Versorgung vom ersten Arztbesuch über die Operation und die anschließende Rehabilitation bis hin zur ambulanten Nachsorge. Ärzte, Therapeuten und Pflegekräfte arbeiten dabei sorgfältig abgestimmt zusammen. Die Pflege und Betreuung pflegebedürftiger Menschen gestaltet MEDICLIN nach deren individuellen Bedürfnissen und persönlichem Bedarf.

MEDICLIN ─ ein Unternehmen der Asklepios-Gruppe.

Allschwil, Switzerland, July 30, 2021

Polyphor to extend period for its strategic evaluation by up to four weeks

Polyphor AG (SIX: POLN) today provided an update regarding the recently announced evaluation of strategic options. This review has become necessary following the negative results of the FORTRESS study for balixafortide. The board of directors has resolved to extend the period for strategic evaluation of all options for the future of the Company by up to four weeks.

The planned restructuring to reduce costs and create operational efficiencies is being completed with the reduction of around 20 employees following the finalization of the consultation process.

For further information please contact:

About Polyphor
Polyphor is a research driven clinical-stage, Swiss biopharmaceutical company committed to discovering and developing best-in-class molecules in oncology and antimicrobial resistance leveraging the company’s leading macrocyclic peptide technology platform. Polyphor has finished patient enrollment of a Phase III trial of balixafortide (POL6326) in combination with eribulin in patients with advanced breast cancer. In addition, it has discovered and is developing the Outer Membrane Protein Targeting Antibiotics (OMPTA). OMPTA are potentially the first new class of antibiotics in clinical development in the last 50 years against Gram-negative bacteria. The company’s lead OMPTA program is an inhaled formulation of murepavadin for the treatment of Pseudomonas aeruginosa infections in patients with cystic fibrosis. Polyphor is based in Allschwil near Basel and is listed on the SIX Swiss Exchange (SIX: POLN). For more information, please visit www.polyphor.com.

Disclaimer
This press release contains forward-looking statements which are based on current assumptions and forecasts of the Polyphor management. Known and unknown risks, uncertainties, and other factors could lead to material differences between the forward-looking statements made here and the actual development, in particular Polyphor’s results, financial situation, and performance. Readers are cautioned not to put undue reliance on forward-looking statements, which speak only of the date of this communication. Polyphor disclaims any intention or obligation to update and revise any forward-looking statements, whether as a result of new information, future events or otherwise.

• As assumed, COVID-19 pandemic continued to impact organic growth in dialysis and downstream businesses
• Patient excess mortality rates significantly reduced
• Negative exchange rate effects continue
• Earnings development impacted by phasing and strong prior-year base, as indicated
• Financial targets for FY 2021 confirmed
• FME25 program on track

Rice Powell, Chief Executive Officer of Fresenius Medical Care, said: “The fact that we saw further easing in COVID-19-related excess mortality among our patients – both on a monthly basis and when looking at a rolling 12-month period – is for sure the good news we hoped for and expected to share today. We are cautious and continue to watch the Delta variant and the increasing macro-economic inflationary impacts.

COVID-19 continues to impact the number of treatments in our dialysis business, the development in our downstream businesses and the speed of closing acquisitions. As indicated in May, we saw the expected significant earnings decline in the second quarter. In addition to the current effects of the pandemic, this was due to the strong prior-year base and the reversal of the favorable phasing of costs we saw in the first quarter. Based on our defined assumptions and the business performance in the first half of the year, we confirm our outlook for the full year 2021.”

Key figures (IFRS)
 

cc = at constant currency, EPS = earnings per share

COVID-19-related excess mortality declined, but continued to adversely affect the business

As expected, COVID-19 related incremental excess mortality among Fresenius Medical Care’s patients has further declined – from 3,100 patients in the first to approximately 1,500 in the second quarter. Thus, it amounted to approximately 11,200 patients in the past 12 months (as of June 30, 2021) and approximately 15,000 since the start of the pandemic. The decrease on a quarterly basis is also a result of continued progress made in patient vaccination, which has led to a further decline in global infection rates. At the end of the second quarter, approximately 71% of Fresenius Medical Care’s patients in the U.S. have received at least one dose, with a high proportion of them already fully vaccinated. On a global basis, also approximately 71% of Fresenius Medical Care’s patients have received at least one vaccination.

Fresenius Medical Care continues to monitor closely the recent COVID-19-related developments, in particular regarding the global spread of the Delta variant and any potential new waves.

As expected, COVID-19-related excess mortality of dialysis patients not only led to an underutilization of Fresenius Medical Care’s dialysis clinics, but also impacted downstream businesses in the first half of the year. Here, the U.S. Healthcare Products as well as the pharmacy business were affected by significantly lower than expected volumes.

The anticipated decline in incremental excess mortality has led to a smaller impact in Q2 than in Q1. The overall adverse COVID-19 impact from accumulated excess mortality on organic growth in the Health Care Services business amounted to around 240 basis points in the second quarter and 290 basis points in the first half of 2021.

Outlook

Based on the results for the second quarter and first half, Fresenius Medical Care confirms its outlook for FY 2021 as outlined in February. The Company expects revenue to grow at a low- to mid-single digit percentage rate and net income to decline at a high-teens to mid-twenties percentage rate against the 2020 base.³ This outlook is based on the assumption of a return to normalized mortality rates in the second half of 2021.

To support its 2025 strategy, further strengthen profitability and compensate for the negative earnings effects of the COVID-19 pandemic, Fresenius Medical Care has initiated the FME25 program. The Company reconfirms its targets and is on track with its work regarding the operating model transformation and efficiency measures. Fresenius Medical Care will provide an update in the fall.

Driving sustainability efforts

Sustainability is an integral part of Fresenius Medical Care’s mission and vision and is reflected in the corporate strategy. The Company is committed to implementing global sustainability standards in its operations around the world. To this end, Fresenius Medical Care is further driving forward its Global Sustainability Program and ESG initiatives:

Fresenius Medical Care has recently joined econsense, a network of companies united in the goal of shaping the transformation to a sustainable economy and society. The dialogue and cross-industry exchange of practical expertise within econsense, which now counts 40 major companies as members, will further support Fresenius Medical Care’s sustainability management.

In July, Fresenius Medical Care has further underlined its commitment to create value in ecological, social and economic terms by signing its first sustainability-linked financing instrument. The Company’s new EUR 2 billion syndicated revolving credit facility includes a component that links its margin development to sustainability performance.

Earnings impacted by COVID-19, negative exchange rate effects and a high prior-year base

Revenue in the second quarter decreased by 5% to EUR 4,320 million (+2% at constant currency, +1% organic).

Health Care Services revenue in the second quarter declined by 6% to EUR 3,400 million (+2% at constant currency, +1% organic). The increase in organic growth in the international regions was more than offset by negative exchange rate effects in all regions as well as by the adverse COVID-19 impact and a lower reimbursement for Calcimimetics in North America.

Health Care Products revenue decreased by 2% to EUR 920 million (+2% at constant currency, +1% organic). The positive organic growth development was mainly driven by higher sales of in-center disposables in EMEA and Asia-Pacific, machines for chronic treatment and renal pharmaceuticals. This positive development was offset mainly by negative exchange rate effects and lower sales of acute care products compared to a strong prior-year base.

In the first half, revenue declined by 6% to EUR 8,530 million (+2% at constant currency, +1% organic). Health Care Services revenue decreased by 7% to EUR 6,726 million (+1% at constant currency, +1% organic); Health Care products revenue declined by 2% to EUR 1,804 million (+3% at constant currency, +3% organic).

Operating income decreased by 35% to EUR 424 million in the second quarter (-30% at constant currency), resulting in a margin of 9.8% (Q2 2020: 14.4%). Operating income excluding special items declined by 34% to EUR 430 million (-29% at constant currency), resulting in a margin of 10.0%. The decrease was mainly due to the adverse impact of the COVID-19 pandemic, including a high prior-year base as a result of government relief funding, the expected phasing and increase in Sales, General and Administrative expense, negative exchange rate effects and higher direct costs. These effects were partially offset in particular by an improved Medicare Advantage payor mix in the U.S.

In the first half, operating income decreased by 26% to EUR 898 million (-20% at constant currency), resulting in a margin of 10.5% (H1 2020: 13.4%). Operating income excluding special items declined by 25% to EUR 907 million (-19% at constant currency), resulting in a margin of 10.6%.

Net income² decreased by 38% to EUR 219 million in the second quarter (-33% at constant currency). Net income excluding special items declined by 37% to EUR 223 million (-31% at constant currency).

In the first half, net income decreased by 26% to EUR 468 million (-21% at constant currency). Net income excluding special items declined by 25% to EUR 474 million (-20% at constant currency).

Basic earnings per share (EPS) decreased by 38% to EUR 0.75 (-33% at constant currency) in the second quarter. EPS excluding special items declined by 37% to EUR 0.76 (-31% at constant currency).

In the first half, EPS decreased by 26% to EUR 1.60 (-20% at constant currency). EPS excluding special items declined by 25% to EUR 1.62 (-19% at constant currency).

Cash flow development

In the second quarter, Fresenius Medical Care generated EUR 921 million of operating cash flow (Q2 2020: EUR 2,319 million), resulting in a margin of 21.3% (Q2 2020: 50.9%). The decline was mainly due to the U.S. federal government’s payments in the second quarter of 2020 under the CARES Act, the start of recoupment of these advanced payments in the second quarter of 2021 as well as the timing of certain other expense payments in 2021. In the first half, operating cash flow amounted to EUR 1,129 million (H1 2020: EUR 2,903 million), resulting in a margin of 13.2% (H1 2020: 32.1%).

Fresenius Medical Care generated EUR 720 million of free cash flow⁴ (Q2 2020: EUR 2,103 million) in the second quarter, resulting in a margin of 16.7% (Q2 2020: 46.1%). In the first half, Free cash flow amounted to EUR 749 million (H1 2020: EUR 2,407 million), resulting in a margin of 8.8% (H1 2020: 26.6%).

Regional developments

In North America, revenue decreased by 9% to EUR 2,953 million in the second quarter (stable at constant currency, -1% organic). Besides a sizable negative exchange rate effect, this was mainly due to the adverse COVID-19 impact on both the Health Care Services and Health Care Products businesses along with associated downstream effects and a lower reimbursement for Calcimimetics. In the first half, revenue decreased by 9% to EUR 5,852 million (stable at constant currency, -1% organic).

Operating income in North America decreased by 35% to EUR 398 million in the second quarter (-29% at constant currency), resulting in a margin of 13.5% (Q2 2020: 18.8%). The decline was mainly due to the adverse impact of COVID-19, including a high prior-year base mainly driven by government relief funding, negative exchange rate effects, increased direct costs and an unfavorable impact from Calcimimetics. This was partially offset by an improved Medicare Advantage payor mix. In the first half, operating income declined by 26% to EUR 796 million (-19% at constant currency), resulting in a margin of 13.6% (H1 2020: 16.7%).

Revenue in EMEA increased by 1% and amounted to EUR 693 million in the second quarter (+2% at constant currency, +2% organic). This was mainly driven by an increase in Health Care Product revenue due to higher sales of acute cardiopulmonary products, renal pharmaceuticals and machines for chronic treatment, partially offset by lower sales of products for acute treatments and negative exchange rate effects. In the first half, revenue was stable and amounted to EUR 1,362 million (+2% at constant currency, +2% organic).

Operating income in the EMEA region decreased by 5% to EUR 73 million in the second quarter (-5% at constant currency), resulting in a margin of 10.6% (Q2 2020: 11.3%). The decline was mainly driven by negative foreign currency transaction effects, higher costs of revenue as well as higher Sales, General and Administrative expense. This was partially offset by the lower prior year base due to an impairment recorded in 2020 for a license held by the joint venture with Vifor Pharma. In the first half, operating income decreased by 14% to EUR 153 million (-14% at constant currency), resulting in a margin of 11.2% (H1 2020: 13.1%).

In Asia-Pacific, revenue increased by 8% to EUR 486 million in the second quarter (+11% at constant currency, +10% organic). This was mainly driven by an increase in Health Care Services revenue, primarily due to a recovery in elective procedures, which was partially offset by exchange rate effects. In the first half, revenue grew by 7% to EUR 957 million (+11% at constant currency, +11% organic).

Operating income increased by 33% to EUR 84 million in the second quarter (+38% at constant currency), resulting in a margin of 17.3% (Q2 2020: 14.1%). The increase was mainly driven by favorable business growth and the above-mentioned recovery in elective procedures, partially offset by unfavorable foreign currency transaction effects. In the first half, operating income grew by 21% to EUR 170 million (+25% at constant currency), resulting in a margin of 17.7% (H1 2020: 15.7%).

Despite a very significant headwind from exchange rates and the adverse impact of
COVID-19, Latin America revenue increased by 1% to EUR 171 million in the second quarter (+17% at constant currency, +14% organic). This was mainly driven by an increase in Health Care Services revenue. In the first half, revenue decreased by 2% to EUR 330 million (+17% at constant currency, +15% organic).

Operating income in Latin America decreased by 76% to EUR 3 million in the second quarter (-82% at constant currency), resulting in a margin of 1.5% (Q2: 2020: 6.4%). The decline was driven by increased bad debt expense in Colombia. In the first half, operating income declined by 48% to EUR 9 million (-49% at constant currency), resulting in a margin of 2.8% (H1 2020: 5.3%).

Patients, Clinics and Employees

As of June 30, 2021, Fresenius Medical Care treated 345,646 patients in 4,125 dialysis clinics worldwide. At the end of the second quarter, the Company had 123,538 employees (full-time equivalents) worldwide, compared to 124,736 employees as of June 30, 2020.

Conference call

Fresenius Medical Care will host a conference call to discuss the results of the second quarter and first half of 2021 on July 30, 2021 at 3:30 p.m. CEST / 9:30 a.m. EDT. Details will be available on the company’s website www.freseniusmedicalcare.com in the “Investors” section. A replay will be available shortly after the call.

Please refer to our statement of earnings included at the end of this news and to the attachments as separate PDF-files for a complete overview of the results of the second quarter and first half of 2021. Our 6-K disclosure provides more details.

Fresenius Medical Care is the world’s leading provider of products and services for individuals with renal diseases of which around 3.7 million patients worldwide regularly undergo dialysis treatment. Through its network of more than 4,100 dialysis clinics, Fresenius Medical Care provides dialysis treatments for approximately 346,000 patients around the globe. Fresenius Medical Care is also the leading provider of dialysis products such as dialysis machines or dialyzers. Along with its core business, the Renal Care Continuum, the company focuses on expanding in complementary areas and in the field of critical care. Fresenius Medical Care is listed on the Frankfurt Stock Exchange (FME) and on the New York Stock Exchange (FMS).

For more information visit the Company’s website at www.freseniusmedicalcare.com.

Disclaimer:
This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to various factors, including, but not limited to, changes in business, economic and competitive conditions, legal changes, regulatory approvals, impacts related to the COVID-19 pandemic results of clinical studies, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care AG & Co. KGaA’s reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care AG & Co. KGaA does not undertake any responsibility to update the forward-looking statements in this release.

^[1] Costs related to the FME25 program
^[2] Net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA
^[3] These targets are based on the 2020 results excluding the impairment of goodwill and trade names in the Latin America Segment of EUR 195 million. They are inclusive of anticipated COVID-19 effects, in constant currency and exclude special items. Special items include costs related to FME25 and other effects that are unusual in nature and have not been foreseeable or not foreseeable in size or impact at the time of giving guidance.
^[4] Net cash provided by / used in operating activities, after capital expenditures, before acquisitions, investments and dividends

Contact:
Dr. Dominik Heger
EVP I Head of Investor Relations, Strategic Development & Communications
dominik.heger@fmc-ag.com
P. +49 6172 609 2525

• SYNLAB supports AXA Partners in enabling customers and employees to resume travel safely
• SYNLAB and AXA Partners leverage SYNLAB’s broad international laboratory network and medical expertise to provide safe and easy COVID-19 testing, ensuring delivery of PCR test results within 24 to 48 hours

SYNLAB, Europe’s leading medical diagnostic services provider, and AXA Partners enter a partnership to facilitate safe and easy travelling for customers and employees. AXA Partners is part of the AXA Group, a global leader in insurance and asset management, with more than 9,000 employees serving customers worldwide.

Leveraging SYNLAB’s broad laboratory network, AXA Partners’ customers and employees are being offered comprehensive COVID-19 testing services in more than 10 European countries, including Spain, Portugal and France and covering around 900 testing centres. The partnership may be extended to include further countries.

PCR tests are considered gold standard for COVID-19 testing, providing the highest possible sensitivity and specificity. A negative PCR test result ensures that customers and employees are not infected with SARS-CoV-2, which helps to protect their environment. In addition, it can also facilitate their on-/homeward journey and border crossing. Besides PCR testing, the partnership also includes antigen tests and self-administrated test kits, if country regulation permits.

AXA Partners’ customers and employees can find SYNLAB laboratories and sample collection points through AXA Partners’ vetted medical network, whereby SYNLAB – as the preferred partner in testing for COVID-19 – is ranked first on search results.

Mathieu Floreani, CEO of SYNLAB, says: “At a time when people around the world want to resume travel and different variants of the SARS-CoV-2 virus are spreading, testing remains crucial. We are pleased that AXA Partners has chosen SYNLAB as the preferred provider for testing. Together, we will make travel as safe as possible for their customers and employees.”

Julia d’Astorg, Chief International Medical Services Officer, AXA Partners: “We at AXA Partners continually strive to provide a best-in-class health services to our customers. This means that when looking for a Partner, we always ensure that their standard of service, ethos and ability to promptly innovate are aligned with ours. We are very happy to have found that in SYNLAB.”

For more information:

About SYNLAB

• SYNLAB, (ISIN: DE000A2TSL71, SYMBOL: SYAB) is the largest European clinical laboratory and medical diagnostic services company and offers a full range of innovative and reliable medical diagnostics for patients, practising doctors, clinics and the pharmaceutical industry.
• Providing the leading level of service within the industry, SYNLAB is the partner of choice for diagnostics in human and veterinary medicine. The Group continuously innovates medical diagnostic services for the benefit of patients and customers.
• SYNLAB operates in 36 countries across four continents and holds leading positions in most markets. More than 20,000 employees, including over 1,200 medical experts, as well as a large number of other specialists such as biologists, chemists and laboratory technicians, contribute every day to the Group’s worldwide success. SYNLAB carries out ~500 million laboratory tests per year and achieved revenues of EUR 2.6 billion in 2020.
• More information can be found on www.synlab.com

Topas Therapeutics Extends Series B, Raising Total of €40 Million (~$ 48 Million) in this Round

• Funds to be used to obtain clinical proof of concept in two programs and to accelerate innovative pipeline focused on restoring immune tolerance to treat and potentially cure autoimmune diseases
• Initial clinical data for lead program, TPM203, in pemphigus vulgaris expected this year; second program, TPM502, planned to enter clinic by year end for celiac disease
• In strong support of Topas’ technology and programs, all existing investors – BioMedPartners, Boehringer Ingelheim Venture Fund, EMBL Ventures, Epidarex Capital, Evotec, Gimv and Vesalius Biocapital III – participated in the extension

Hamburg, 29 July 2021.
Topas Therapeutics GmbH (Topas), a private biotechnology company developing immune tolerance-inducing drugs to treat and potentially cure a variety of autoimmune diseases, today announced that the Company has successfully extended its Series B round with an additional €18 million (~$22 million) raised, bringing the total for this financing to €40 million. All of Topas’ existing investors participated in the extension.

The funding will be used to obtain clinical proof of concept in two programs and to accelerate the Company’s proprietary pipeline based on the Topas Particle Conjugates technology platform. In addition to lead program, TPM203, which is continuing in clinical development for the treatment of pemphigus vulgaris, a second product candidate, TPM502, is now slated to enter the clinic for the treatment of celiac disease by the end of this year.

Topas will also be advancing several of its pre-clinical-stage programs, including one for the treatment of rheumatoid arthritis and one for Type I diabetes. Topas’ novel technology induces antigen-specific immune tolerance by harnessing the liver’s natural tolerization capabilities. The Company is utilizing this platform to develop products for autoimmune diseases where better treatment options and cures are urgently needed.

Klaus Martin, Ph.D., Chief Executive Officer of Topas, said: “We are excited by the trust our investors are showing by participating in this extended financing round, recognizing our progress and underpinning their great belief in the potential of Topas’ innovative technology and programs. This strong support is enabling us to accelerate our product development work and to advance several programs in parallel. We look forward to seeing the first clinical results from our platform, expected later this year.”

Topas has raised a total of €58 million since its inception. The recent Series B extension is enabling the Company to accelerate the development of various autoimmune disease programs.

Erich F. Greiner, M.D., Chairman of the Supervisory Board, said: “I am very pleased and grateful that all of Topas’ investors decided to further strengthen the Company and its programs. We are delighted by the progress we have made to date with the Topas nanoparticle conjugate technology platform and eagerly await the first clinical results. Once clinical proof of concept is established, we see multiple opportunities for this unique and versatile platform to rapidly generate additional exciting programs in a variety of disease areas. The Topas technology has the potential to bring truly breakthrough products to patients with diseases of high unmet medical need for which there are currently no effective or curative treatment options.”

About Topas Therapeutics

Topas Therapeutics GmbH is a clinical-stage, private biotechnology company, which focuses on developing nanoparticle-based therapeutics to address areas of major unmet need, including autoimmune diseases, allergies, and anti-drug immune responses. The Topas Particle Conjugates technology platform induces antigen-specific immune tolerance by harnessing the liver’s natural tolerization capabilities. The Company has several proprietary programs; lead product candidate, TPM203, is in clinical testing for pemphigus vulgaris, an orphan disease. A second program, TPM 502, is being developed for the treatment of celiac disease and expected to enter the clinic by the end of the year. Topas has several other proprietary programs, including in rheumatoid arthritis and Type I diabetes, in pre-clinical development. Other programs are in the area of anti-drug immune responses, such as in gene therapy and with anti-drug antibodies and are available for partnering. Topas’ investors are: BioMedPartners, Boehringer Ingelheim Venture Fund, EMBL Ventures, Epidarex Capital, Evotec, Gimv and Vesalius Biocapital III.

For additional information, please visit www.topas-therapeutics.com.

Contacts:

Media Release

MorphoSys AG Reports Second Quarter and First Half 2021 Results

– Monjuvi U.S. net product sales of € 14.9 million (US$ 18.0 million), 16% growth Q-Q
– MorphoSys announced and subsequently completed its acquisition of Constellation Pharmaceuticals
– Announced and closed ~US$ 2.0 billion strategic funding partnership with Royalty Pharma
– Updated group financial guidance
– Conference call and webcast (in English) tomorrow, July 29, 2021, at 2:00pm CEST
(1:00pm BST/8:00am EDT)

MorphoSys AG (FSE: MOR; NASDAQ: MOR) reports financial results for the second quarter and the first half year of 2021.

“We regained the momentum in Monjuvi sales as we exited the second quarter and are encouraged to see that momentum continuing into Q3,” said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. “We are seeing the positive impact to our business from the vaccination rollout in the U.S., and remain focused on establishing tafasitamab as a standard of care in the treatment of patients with relapsed/refractory DLBCL.”

“With the addition of Constellation’s clinical programs to our pipeline, we are in a great position to build a significant presence in hematology-oncology with multiple commercial opportunities.”

Tafasitamab Highlights

– Monjuvi^(R) (tafasitamab-cxix) U.S. net product sales of € 14.9 million (US$ 18.0 million) for the second quarter of 2021 and € 27.8 million (US$ 33.5 million) for the first half of 2021.

– On April 19, 2021, MorphoSys and Incyte announced that the first patient has been dosed in the placebo-controlled Phase 3 inMIND study evaluating the efficacy and safety of tafasitamab or placebo in combination with lenalidomide and rituximab in patients with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL).

– On May 11, 2021, MorphoSys and Incyte announced that the first patient was dosed in the pivotal Phase 3 frontMIND study evaluating tafasitamab and lenalidomide in addition to rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) compared to R-CHOP alone as first-line treatment for high-intermediate and high-risk patients with untreated diffuse large B-cell lymphoma (DLBCL).

– From June 4-8, 2021, MorphoSys presented new data from the tafasitamab development program at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. Data from the three-year follow-up from the Phase 2 L-MIND study showed a long durability of responses and overall survival in patients with r/r DLBCL.

– On June 25, 2021, MorphoSys and Incyte announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the conditional marketing authorization for tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT). The Committee for Orphan Medicinal Products (COMP) has also confirmed the orphan drug designation status in mid-July.

– Together with MorphoSys, Incyte plans to start coreMIND, a pivotal Phase 2 study that will assess tafasitamab in combination with Incyte’s Pi3 kinase delta inhibitor in patients with chronic lymphocytic leukemia (CLL).

– MorphoSys will also initiate MINDway, a study that will look into finding the best treatment schedule for patients with Non-Hodgkin Lymphoma (NHL) who benefit from long-term disease-control from tafasitamab.

Acquisition of Constellation Pharmaceuticals and Strategic Funding Partnership

– On June 2, 2021, MorphoSys entered into a definitive agreement to acquire Constellation Pharmaceuticals (Constellation) for US$ 34.00 per share in cash, which represents a total equity value of US$ 1.7 billion. The transaction has been unanimously approved and subsequently was completed on July 15, 2021.

– MorphoSys gets access to mid- to late-stage product candidates: Pelabresib (CPI 0610) has the potential to be a first-in-class and best-in-class BET inhibitor that is currently being evaluated in a Phase 3 trial for the treatment of myelofibrosis. CPI-0209 is a mid-stage EZH2 inhibitor, which is currently in a Phase 2 clinical trial and has best-in-class potential for treating both hematologic and solid tumors.

– MorphoSys entered into a long-term strategic funding partnership with Royalty Pharma:

– US$ 1.425 billion upfront payment

– Up to US$ 350 million in Development Funding Bonds

– Up to US$ 150 million milestone payments

– Royalty Pharma Investments 2019 ICAV, a subsidiary of Royalty Pharma plc, purchased US$ 100 million in shares (1,337,552 shares) of MorphoSys at a price of € 63.35 per share on July 16, 2021

– MorphoSys also announced today that Jigar Raythatha, President and Chief Executive Officer of Constellation, will resign effective July 31, 2021. Barbara Krebs-Pohl, PhD, Senior Vice President, Global Head of Business Development, Licensing, and Alliance Management at MorphoSys, has been appointed as Site Head of Constellation and Chief Integration Officer.

Tremfya:

– MorphoSys to continue to record Tremfya royalties on its income statement. Royalty Pharma is entitled to receive 100 percent of Tremfya royalties starting with royalties for the second quarter of 2021.

– Tremfya royalties of € 13.7 million for the second quarter of 2021 and € 25.4 million for the first half of 2021.

Financial Results for the Second Quarter of 2021 (IFRS)
Total revenues for the second quarter of 2021 amounted to € 38.2 million (Q2 2020: € 18.4 million). The revenues include success-based payments of € 14.2 million, primarily from Janssen (Q2 2020 success-based payments: € 12.8 million).

Cost of Sales: In the second quarter of 2021, cost of sales increased to € 10.1 million (Q2 2020: income of € 7.2 million).

Research and Development (R&D) Expenses: In the second quarter of 2021, research and development expenses were € 40.5 million (Q2 2020: € 30.9 million). Growth over 2020 reflects the increased investment to support the advancement of proprietary programs and consisted primarily of expenses for external laboratory services and personnel expenses.

Selling, General and Administrative (SG&A) Expenses: Selling expenses decreased slightly in the second quarter of 2021 to € 28.5 million (Q2 2020: € 29.3 million) and general and administrative expenses amounted to € 30.5 million (Q2 2020: € 13.8 million). The increase of general and administrative expense in the second quarter was due to the transaction costs related to the Constellation and Royalty Pharma agreements.

Operating Loss: Operating loss amounted to € 71.4 million in the second quarter of 2021 (Q2 2020: operating loss of € 48.4 million).

Consolidated Net Profit / Loss: For the second quarter of 2021, consolidated net profit was € 20.9 million (Q2 2020: consolidated net loss of € 53.1 million).

Financial Results for the First 6 Months of 2021 (IFRS)

Total revenues for the first six months of 2021 amounted to € 85.4 million (H1 2020: € 269.7 million). The revenues include success-based payments of € 43.1 million, primarily from Janssen (H1 2020 success-based payments: € 23.1 million) The year-over-year decline was driven by the upfront payment of the collaboration and license agreement with Incyte in the first quarter 2020 for the out-licensing of tafasitamab outside the U.S.

*Differences due to rounding

Cost of Sales: In the first six months of 2021, cost of sales increased to € 15.2 million (H1 2020: income of € 4.0 million).

Research and Development (R&D) Expenses: In the first six months of 2021, research and development expenses were € 73.8 million (H1 2020: € 52.4 million). Growth over 2020 reflects the increased investment to support the advancement of proprietary programs and consisted primarily of expenses for external laboratory services and personnel expenses.

Selling, General and Administrative (SG&A) Expenses: Selling expenses increased in the first six months of 2021 to € 56.6 million (H1 2020: € 42.1 million) and general and administrative expenses amounted to € 40.8 million (H1 2020: € 23.9 million). The year-over-year increase in selling expenses was primarily driven by the full first half year 2021 impact of the expenses for services provided by Incyte as part of the joint U.S. marketing activities for Monjuvi. The year-over-year increase in general and administrative expenses was driven primarily by the transaction costs related to the Constellation and Royalty Pharma agreements.

Operating Loss: Operating loss amounted to € 101.0 million in the first six months of 2021 (H1 2020: operating profit of € 155.1 million).

Consolidated Net Profit / Loss: For the first six months of 2021, consolidated net loss was € 20.7 million (H1 2020: consolidated net profit of € 179.8 million).

Cash and Investments: As of June 30, 2021, the Company had cash and investments of € 1,129.2 million compared to € 1,244.0 million on December 31, 2020. Pro forma cash after the closing of the Constellation and Royalty Pharma transactions, including the sale of ordinary shares, was € 1,168.0 million.

Number of shares: The number of shares issued totaled 32,892,540 at the end of Q2 2021 (year-end 2020: 32,890,046). After the share capital increase on July 16, 2021, to implement the purchase of 1,337,552 new ordinary shares by Royalty Pharma, the number of shares issued totaled 34,227,598.

Adjusted Financial Guidance and Operational Outlook for 2021

*Group revenues include full year Tremfya royalties and exclude any royalties from potential tafasitamab sales outside of the U.S. as well as any significant milestones from development partners and/or licensing partnerships other than those that were already recorded in the half-year. This revenue guidance is subject to a number of uncertainties including the potential for variability from the first full year of the Monjuvi product launch, the limited visibility that MorphoSys has on the Tremfya royalty stream as well as the ongoing COVID-19 pandemic and the impact on our as well as our partner’s business operations.

**Operating expenses is comprised of R&D and SG&A, inclusive of Incyte’s share of Monjuvi selling costs in the U.S.

MorphoSys expects the following events and activities in 2021:

Tafasitamab:

– Continuation of the phase 1b trial with tafasitamab in previously untreated DLBCL (firstMIND);

– Continuation of the pivotal phase 3 frontMIND trial of tafasitamab in previously untreated DLBCL;

– Continuation of the pivotal phase 3 inMIND trial of tafasitamab in patients with relapsed or refractory follicular lymphoma (r/r FL) or marginal zone lymphoma (MZL);

– Investigation of tafasitamab, plamotamab and lenalidomide in patients with relapsed or refractory DLBCL, first-line DLBCL and relapsed or refractory follicular lymphoma (r/r FL) jointly with Incyte and Xencor (study start expected end of 2021/early 2022);

– Continuation of the L-MIND study of tafasitamab and evaluate the long-term efficacy and safety data;

– Continuation of the phase 3 B-MIND study of tafasitamab in combination with bendamustine for r/r DLBCL;

– Decision of the European Commission on the Marketing Authorization Application (MAA), seeking conditional marketing authorization of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with r/r DLBCL which is currently under review;

– Support of Incyte in submitting marketing authorization applications in other markets for tafasitamab.

Felzartamab:

– Continuation of the M-PLACE and the NewPLACE study in patients with membranous nephropathy;

– Presentation of data from the M-PLACE study at a scientific conference in Q4 2021;

– Start of clinical study in patients with IgA nephropathy (IGNAZ study).

Constellation programs:

– Continuation of the MANIFEST phase 2 study of pelabresib in patients with myelofibrosis;

– Continuation of the MANIFEST-2 phase 3 clinical study with pelabresib in combination with ruxolitinib in patients with primary myelofibrosis;

– Continuation of a Phase 1/2 clinical trial of CPI-0209 in patients with advanced solid and hematological tumors.

MorphoSys Group Key Figures (IFRS, June 30, 2021)

*Value as of December 31, 2020

MorphoSys will hold its conference call and webcast tomorrow, July 29, 2021, to present the results for the second quarter and first half year of 2021 and the further outlook for 2021.

Dial-in number for the conference call (in English) at 2:00pm CEST; 1:00pm BST; 8:00am EDT:
Germany: +49 69 201 744 220
For UK residents: +44 203 009 2470
For US residents: +1 877 423 0830
(All numbers reachable from any geography)
Participant PIN: 72989449#
Please dial in 10 minutes before the beginning of the conference.

A live webcast and slides will be made available at the Investors section under “Presentations and Conferences” on MorphoSys’ website at http://www.morphosys.com and after the call, a slide-synchronized audio replay of the conference will be available at the same location.

The statement for the second quarter/first 6 months of 2021 (IFRS) is available online:
http://www.morphosys.com/Reports

About Tafasitamab
Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb^(R) engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

Monjuvi^(R) (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi^(R) is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with lenalidomide in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, who are not candidates for ASCT.

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

Monjuvi^(R) is a registered trademark of MorphoSys AG.
XmAb^(R) is a registered trademark of Xencor, Inc.

About MorphoSys
MorphoSys (FSE & NASDAQ: MOR) is a biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for people living with cancer and autoimmune diseases. Based on its leading expertise in antibody and protein technologies, MorphoSys is advancing its own pipeline of new drug candidates and has created antibodies that are developed by partners in different areas of unmet medical need. In 2017, Tremfya^(R) (guselkumab) – developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc. for the treatment of plaque psoriasis – became the first drug based on MorphoSys’ antibody technology to receive regulatory approval. In July 2020, the U.S. Food and Drug Administration granted accelerated approval of the company’s proprietary product Monjuvi^(R) (tafasitamab-cxix) in combination with lenalidomide for patients with a certain type of lymphoma. Headquartered near Munich, Germany, the MorphoSys Group, including the fully owned U.S. subsidiaries MorphoSys US Inc. and Constellation Pharmaceuticals, Inc., has more than 750 employees. For more information visit www.morphosys.com or www.morphosys-us.com.

Monjuvi^(R) is a registered trademark of MorphoSys AG.
Tremfya^(R) is a registered trademark of Janssen Biotech, Inc.

MorphoSys Forward-Looking Statements
This communication contains certain forward-looking statements concerning the MorphoSys group of companies. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys’ results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are that MorphoSys’ expectations may be incorrect, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements, MorphoSys’ reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys’ Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

For more information, please contact:

Media release

Medacta Expands Hip Revision Portfolio, Unveiling Cutting-Edge Implants for Acetabulum and Femur

CASTEL SAN PIETRO, 28 July 2021 – Medacta is announcing the first surgeries utilizing its
AMIS^(R)-K Long, Iliac Screw Mpact^(R) 3D Metal, and 3D Metal^(R) B-Cage, after each of the items received CE marking. These new products, alongside the M-Vizion^(R) Modular Femoral Revision Stem, further broaden the Medacta Hip Revision Platform.

“Medacta is constantly striving to provide surgeons with the versatility required to meet their patients’ needs, whether it’s a complex primary case or a difficult revision,” said Francesco Siccardi, CEO of Medacta. “By further expanding our Hip Revision Platform, we are well-positioned to meet our goal of being a uniquely valuable partner for hip surgeons worldwide. The introduction of these new products and the next exciting ones that will be launched in the coming months are evidence of our commitment to supporting surgeons in providing personalized treatments for patients, so that they can return to a healthy and active lifestyle,” added Siccardi.

ACETABULUM
The 3D Metal B-Cage is the latest addition to Medacta Reinforcement Cages Portfolio allowing surgeons to cover even the most challenging acetabular revision cases with major bone defects. Featuring an anatomical, anterior-friendly design, that simplifies implant introduction and thanks to the innovative design of the dome and flanges, an enhanced range of sizes, and the unique compatibility with lag and compression polyaxial locking screws, the 3DMetal B-Cage enables surgeons to bridge acetabular areas of bone loss or acetabular fractures with a brilliant approach.

An enhancement to the Mpact System for primary and complex hip revision procedures, the Iliac Screw Mpact 3D Metal is a cementless acetabular ultra-porous titanium shell with a modular polyaxial iliac screw. It provides surgeons with a comprehensive and versatile range of options to address a variety of complex hip replacement cases. The Iliac Screw Mpact 3D Metal is particularly appropriate in settings with extensive acetabular bone loss or special anatomy as it makes use of the iliac isthmus for support and fixation.

Because stability and fixation are key elements of hip replacement surgery, the Iliac Screw Mpact 3D Metal and the 3D Metal B-Cage are manufactured with Medacta’s distinguishing in-house 3D Metal technology, based on the state-of-the-art of metal 3D printing. The result is that these products are uniquely engineered to maximize the intended use of each device. With a high coefficient of friction, high porosity and large pore sizes constructed via 3D additive manufacturing, this advanced structure allows for an enhanced initial stability and provides a favorable environment for long-term metal-bone biologic fixation.

Furthermore, the surgical technique and the instrumentation for both implants have been developed to allow for streamlined implantation, either via a traditional or a minimally invasive anterior approach.

FEMUR
Because Medacta knows that implant versatility is vital in supporting surgeons’ efforts to provide personalized patient care, AMIS-K Long has been added to the AMIS-K family of implants. The AMIS-K Long-a Charnley-Kerboull long cemented stem specifically designed for revision THA-features a variety of lengths, shapes, and sizes. As such, surgeons have maximum intraoperative flexibility for treating a range of pathologies and patients, coupled with straightforward, modular instrumentation.

The M-Vizion Femoral Modular Revision System, the core of the Medacta Hip Revision Platform, allows surgeons to feel more confident in the OR when undertaking femoral revision cases. Introduced to the market in 2017 on a restricted basis and expanded in late 2020 with a broader range of options, the M-Vizion was developed with the support of surgeon leaders in the global orthopaedic community. Known for delivering maximum stability and versatility, and for providing a simplified and streamlined procedure, the M-Vizion is now being fully released into the market with positive preliminary results.

“The M-Vizion modular implant design and easy to use instrumentation offer a highly versatile solution, allowing for a reliable and efficient treatment of various femoral bone defects, even in the most difficult revision scenarios,” says Prof. Philippe Laffargue, orthopaedic surgeon at the Clinique du Sport et de la Chirurgie Orthopédique (CSCO), in Marcq-en-Barœul, France. “The system provides me with great confidence going into surgery, knowing that I will have the right implant configuration with a secure fixation to meet the specific needs of my patients.“

The AMIS-K Long, Iliac Screw Mpact 3D Metal, 3D Metal B-Cage implants and their cutting-edge concepts will be introduced into the market in selected medical centers following the guidelines of the Medacta Orthopaedic Research and Education (M.O.R.E.) Excellence Clinical Program. Under this program, Medacta releases new products on a restricted basis to conduct voluntary clinical programs in order to further confirm and document their safety and efficacy ahead of their full release.

The Medacta Hip Revision Implant Portfolio, uniquely compatible with the AMIS technique, is supported and complemented by a complete range of dedicated instruments to facilitate both failed implant and cement removal.

The tailored educational offering on revision hip replacement is expanding in parallel with the product portfolio. With an international network of expert surgeons, the M.O.R.E. Institute is at the forefront of education on revision techniques and products with personalized high-level educational pathways supporting surgeons with focused activities as they master revision.

To learn more about Medacta’s hip portfolio, please visit hip.medacta.com

Contact
Medacta International SA
Gianluca Olgiati
Senior Director Global Marketing
Phone: +41 91 696 60 60
media@medacta.ch

About Medacta
Medacta is an international company specializing in the design, production, and distribution of innovative orthopaedic products, as well as in the development of accompanying surgical techniques. Established in 1999 in Switzerland, Medacta is active in joint replacement, spine surgery, and sports medicine. Medacta is committed to improving the care and well-being of patients and maintains a strong focus on healthcare sustainability. Medacta’s innovation, forged by close collaboration with surgeon leaders globally, began with minimally invasive surgical techniques and has evolved into personalized solutions for every patient. Through the M.O.R.E. Institute, Medacta supports surgeons with a comprehensive and tailored program dedicated to the advancement of medical education. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 40 countries.