Interim Report September 1, 2019 – May 31, 2020

Company announcement No. 16/2020

Growth momentum and EBIT margin improved in Q3; exploring strategic options for natural colors

Organic revenue growth of 7% in Q3, corresponding to 4% EUR growth, with an improved momentum compared to 1H as expected; Food Cultures & Enzymes 8%, Health & Nutrition 12% and Natural Colors 1%, increasing the Group organic revenue growth in the first nine months of 2019/20 to 5%. COVID-19 impacts on revenues in Q3 were a net positive. In Q3, EBIT before special items increased by 5% to EUR 97 million, and EBIT margin before special items increased by 0.4 %-point to 30.8%.
The full-year outlook on organic growth and EBIT margin b.s.i. is unchanged, while FCF b.a.s.i is increased to above EUR 200 million.

CEO Mauricio Graber says: “We are pleased with our Q3 performance, as our business demonstrated resilience during the first volatile months since the outbreak of COVID-19 thanks to our essential natural ingredient solutions for the food, nutritional and agricultural industries. Customers increased safety stocks of essential ingredients in March and early April, to carry them through potential supply chain disruptions and then inventories began to normalize late April and in May. Our innovative solutions have proved their value, and we were able to continue the strong momentum from recent product launches.

“Our Q3 EBIT margin before special items was up by 0.4%-point driven by scalability benefits in production and lower travel expenses due to COVID-19 travel restrictions – however, these positives were partly offset by higher freight costs that were also driven by COVID-19. Our strong business model and financial position allows us to sustain investments in growth opportunities and innovation. Free cash flow before acquisitions and special items grew by 117% in Q3 and is up 161% after nine months, primarily due to good management of working capital. The Q3 performance was in line with our expectations, and based on the business performance after nine months, we maintain our organic growth and EBIT margin guidance for the full year and increase the free cash flow before acquisitions and special items, although macroeconomic and end-market uncertainty persist due to COVID-19.

“We also completed an acquisition in Q3, and signed another early in Q4. HSO Health Care and UAS Laboratories represent important investments in our microbial platform, and we expect to continue to extend our platform through a disciplined acquisition strategy.

“As part of the strategic review, the Board of Directors and the Executive Board have considered the portfolio of Chr. Hansen, and given that Natural Colors does not share the microbial and fermentation technology platforms, strategic options for the future of Natural Colors will be explored, including a potential sale of the business. We also announce August 25 as the new date for our virtual Capital Markets Day, where we will present all the results of the on-going strategy review.”

Conference call
Chr. Hansen will host a conference call on July 2, 2020 at 10:00 am CET. The conference call can be accessed via the Company’s website, www.chr-hansen.com.

For further information, please contact:
Martin Riise, Head of IR
+45 53 39 22 50
Annika Stern, IR Officer
+45 23 99 23 82

 

About Chr. Hansen
Chr. Hansen is a leading global bioscience company that develops natural ingredient solutions for the food, nutritional, pharmaceutical and agricultural industries. We develop and produce cultures, enzymes, probiotics and natural colors for a rich variety of foods, confectionery, beverages, dietary supplements and even animal feed and plant protection. Our product innovation is based on around 40,000 microbial strains – we like to refer to them as “good bacteria.” Our solutions enable food manufacturers to produce more with less – while also reducing the use of chemicals and other synthetic additives – which makes our products highly relevant in today’s world. Sustainability is an integral part of Chr. Hansen’s vision to improve food and health. In 2019 Chr. Hansen was ranked as the world’s most sustainable company by Corporate Knights thanks to our strong sustainability efforts and our many collaborative partnerships with our customers. We have been delivering value to our partners – and, ultimately, end consumers worldwide – for over 145 years.  We are proud that more than 1 billion people consume products containing our natural ingredients every day.

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Kiadis to present at the Solebury Trout & Venrock EU Virtual Summer Event

Amsterdam, The Netherlands, July 2, 2020 – Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company, today announces that Kiadis will present at the Solebury Trout & Venrock EU Virtual Summer Event on Tuesday, July 7, 2020 at 12:00pm EDT.

Kiadis contacts

 

Kiadis:
Maryann Cimino, Sr. Manager, Corporate Affairs
Tel: +1 (617) 710-7305
m.cimino@kiadis.com

 

LifeSpring LifeSciences Communication:
Leon Melens (Amsterdam)
Tel: +31 538 16 427
lmelens@lifespring.nl

Optimum Strategic Communications:
Mary Clark, Supriya Mathur
Tel: +44 203 950 9144
kiadis@optimumcomms.com

 

Dutch Translation/Nederlandse vertaling

Kiadis Pharma nv (‘Kiadis’) (Euronext Amsterdam en Brussel: KDS), een biofarmaceutisch bedrijf gericht op onderzoek in de klinische fase, kondigt vandaag aan dat Kiadis op dinsdag 7 juli 2020 om 12.00 uur EDT een presentatie zal geven op het Solebury Trout & Venrock EU Virtual Summer Event.

Dit persbericht vormt een vertaling van het gepubliceerde Engelstalige persbericht. Bij eventuele verschillen is de tekst van het Engelstalige persbericht altijd bepalend.

About Kiadis’ K-NK-Cell Therapies
Kiadis’ NK-cell programs consist of off-the-shelf and haplo donor cell therapy products for the treatment of liquid and solid tumors as adjunctive and stand-alone therapies. 

The Company’s NK-cell PM21 particle technology enables improved ex vivo expansion and activation of anti-cancer cytotoxic NK-cells supporting multiple high-dose infusions. Kiadis’ proprietary off-the-shelf NK-cell platform is based on NK-cells from unique universal donors. The Kiadis off-the-shelf K-NK platform can make NK-cell therapy product rapidly and economically available for a broad patient population across a potentially wide range of indications.

Kiadis is clinically developing K-NK003 for the treatment of relapse/refractory acute myeloid leukemia. The Company is also developing K-NK002, which is administered as an adjunctive immunotherapeutic on top of HSCT and provides functional, mature and potent NK-cells from a haploidentical family member. In addition, the Company has pre-clinical programs evaluating NK-cell therapy for the treatment of solid tumors. 

About Kiadis
Founded in 1997, Kiadis is building a fully integrated biopharmaceutical company committed to developing innovative therapies for patients with life-threatening diseases. With headquarters in Amsterdam, the Netherlands, and offices and activities across the United States, Kiadis is reimagining medicine by leveraging the natural strengths of humanity and our collective immune system to source the best cells for life.

Kiadis is listed on the regulated market of Euronext Amsterdam and Euronext Brussels since July 2, 2015, under the symbol KDS. Learn more at www.kiadis.com.

Forward Looking Statements
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect Kiadis’ or, as appropriate, Kiadis’ officers’ current expectations and projections about future events. By their nature, forward-looking statements involve a number of known and unknown risks, uncertainties and assumptions that could cause actual results, performance, achievements or events to differ materially from those expressed, anticipated or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, regulation, competition and technology, can cause actual events, performance, achievements or results to differ significantly from any anticipated or implied development. Forward-looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, Kiadis expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or projections, or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither Kiadis nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the anticipated or implied developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Zomedica Pharmaceuticals Corp. Announces $30 Million Public Offering

ANN ARBOR, Mich., July 01, 2020 (GLOBE NEWSWIRE) — Zomedica Pharmaceuticals Corp. (NYSE American: ZOM), (“Zomedica” or the “Company”), a veterinary diagnostic company, today announced the pricing of its previously announced public offering of 187,500,000 common shares (or common share equivalents) of the Company, together with short-term warrants to purchase up to 187,500,000 common shares, at a combined public offering price of $0.16 per share and accompanying warrant. Each common share (or common share equivalent) is being sold in the offering together with one two-year warrant to purchase one common share at an exercise price of $0.16 per common share. There is no public trading market for the warrants, and Zomedica does not expect a market to develop.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. 

The gross proceeds are expected to be approximately $30 million, before deducting placement agent’s fees and other offering expenses payable by the Company, assuming none of the warrants sold in this offering are exercised for cash. The offering is expected to close on or about July 7, 2020, subject to satisfaction of customary closing conditions. 

Zomedica intends to use the net proceeds from the offering primarily for the continued development of its TRUFORMA™ diagnostic platform, including making milestone payments, as they come due, under its existing license and collaboration agreements, other general corporate and working capital purposes and may use a portion of the net proceeds to repurchase some or all of its outstanding Series 1 Preferred Shares, although no agreement has been reached with respect to the terms or conditions of any such repurchase.

A shelf registration statement on Form S-3 (Registration No. 333-228926) relating to the securities being offered was filed with the Securities and Exchange Commission (“SEC”) and was declared effective on January 30, 2019. The offering is being made only by means of a prospectus supplement and accompanying base prospectus. A preliminary prospectus supplement and accompanying base prospectus relating to the offering was filed with the SEC on July 1, 2020 and is available for free on the SEC’s website located at http://www.sec.gov. When available, electronic copies of the final prospectus supplement and accompanying base prospectus relating to the public offering may be obtained by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996, or by email to placements@hcwco.com.

The common shares (or common share equivalents) and the warrants are not being offered to residents of Canada or persons in Canada. The common shares (or common share equivalents), warrants and the common shares underlying the warrants and the common share equivalents are being sold on the basis of prospectus exemptions under applicable Canadian securities laws on the basis that the securities will not be distributed back into Canada.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying base prospectus forming a part of the effective registration statement.

About Zomedica
Based in Ann Arbor, Michigan, Zomedica (NYSE American:ZOM) is a veterinary diagnostic company creating products for companion animals (canine, feline and equine) by focusing on the unmet needs of clinical veterinarians. Zomedica’s product portfolio will include novel diagnostics and innovative therapeutics that emphasize patient health and practice health. With a team that includes clinical veterinary professionals, it is Zomedica’s mission to give veterinarians the opportunity to lower costs, increase productivity, and grow revenue while better serving the animals in their care. For more information, visit www.ZOMEDICA.com.

Follow Zomedica

Forward-Looking Statements
Except for statements of historical fact, this news release contains certain “forward-looking information” or “forward-looking statements” (collectively, “forward-looking information”) within the meaning of applicable securities law. Forward-looking information is frequently characterized by words such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate” and other similar words, or statements that certain events or conditions “may” or “will” occur and include statements relating to Zomedica’s expectations regarding the public offering. Although we believe that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. We cannot guarantee future results, performance or achievements. Consequently, there is no representation that the actual results achieved will be the same, in whole or in part, as those set out in the forward-looking information.

Forward-looking information is based on the opinions and estimates of management at the date the statements are made and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking information. Some of the risks and other factors that could cause the results to differ materially from those expressed in the forward-looking information include, but are not limited to: market conditions, the completion of the public offering, the satisfaction of customary closing conditions related to the public offering and the intended use of net proceeds from the public offering. There can be no assurance that Zomedica will be able to complete the public offering on the anticipated terms, or at all, as well as uncertainty as to whether our strategies and business plans will yield the expected benefits; uncertainty as to the timing and results of development work and pilot and pivotal studies, uncertainty as to the likelihood and timing of regulatory approvals, availability and cost of capital; the ability to identify and develop and achieve commercial success for new products and technologies; veterinary acceptance of our products; competition from related products; the level of expenditures necessary to maintain and improve the quality of products and services; changes in technology and changes in laws and regulations; our ability to secure and maintain strategic relationships; risks pertaining to permits and licensing, intellectual property infringement risks, risks relating to future clinical trials, regulatory approvals, safety and efficacy of our products, the use of our product, intellectual property protection, risks related to the novel coronavirus disease 2019 (“COVID-19”) and its impact upon Zomedica’s business operations generally, including Zomedica’s ability to develop its diagnostic and therapeutic products, and the other risk factors disclosed in our filings with the Securities and Exchange Commission and under our profile on SEDAR at www.sedar.com. Readers are cautioned that this list of risk factors should not be construed as exhaustive.

The forward-looking information contained in this news release is expressly qualified by this cautionary statement. We undertake no duty to update any of the forward-looking information to conform such information to actual results or to changes in our expectations except as otherwise required by applicable securities legislation. Readers are cautioned not to place undue reliance on forward-looking information.

Investor Relations Contact:
PCG Advisory Group
Kirin Smith, COO
ksmith@pcgadvisory.com
+1 646.863.6519

Media Contact:
Meredith Newman
mnewman@zomedica.com
+1 734.369.2555 ext. 119

 

AETERNA ZENTARIS ANNOUNCES PRICING OF $12 MILLION PUBLIC OFFERING

CHARLESTON, S.C., July 01, 2020 (GLOBE NEWSWIRE) — Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) ( the “Company”), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today announced the pricing of a public offering of 26,666,666 units at a price to the public of $0.45 per unit, for gross proceeds of $12 million, before deducting placement agent fees and other offering expenses payable by the Company. Each unit contains one common share (or common share equivalent) and one common warrant to purchase one common share. The common shares (or common share equivalents) and common share warrants included in the units can only be purchased together in this offering but will be issued separately and will be immediately separable upon issuance. The offering is expected to close on or about July 7, 2020, subject to satisfaction customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

Each common share warrant has an exercise price of $0.45 per share, is exercisable immediately and will expire five years from the date of issuance.

The Company intends to use the net proceeds of this offering for general corporate purposes, which includes, among other purposes, the funding of a pediatric clinical trial in the E.U. and U.S. for Macrilen™ (macimorelin), the investigation of further therapeutic uses of macimorelin and the expansion of pipeline development activities.

The securities described above are being offered by Aeterna Zentaris pursuant to an effective registration statement on Form F-1 (File No. 333-232935) filed with the Securities and Exchange Commission (“SEC”) and declared effective on July 1, 2020. The offering is being made only by means of a prospectus forming part of the effective registration statement. The final terms of the offering will be disclosed in a final prospectus to be filed with the SEC and made available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus, when available, may also be obtained by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996 or by email at placements@hcwco.com.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. No Canadian prospectus has been or will be filed in a province or territory of Canada to qualify the common shares or the warrants in connection with the offering.

About Aeterna Zentaris Inc.

Aeterna Zentaris Inc. is a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests. The Company’s lead product, Macrilen™ (macimorelin), is the first and only U.S. FDA and European Commission approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). Macrilen™ is currently marketed in the United States through a license agreement with Novo Nordisk and Aeterna Zentaris receives double-digit royalties on sales. Aeterna Zentaris owns all rights to macimorelin outside of the U.S. and Canada.

Aeterna Zentaris is also leveraging the clinical success and compelling safety profile of macimorelin to develop it for the diagnosis of child-onset growth hormone deficiency (CGHD), an area of significant unmet need.

The Company is actively pursuing business development opportunities for the commercialization of macimorelin in Europe and the rest of the world, in addition to other non-strategic assets to monetize their value. For more information, please visit www.zentaris.com and connect with the Company on Twitter, LinkedIn and Facebook.

Forward-Looking Statements

This press release contains forward-looking statements (as defined by applicable securities legislation) made pursuant to the safe-harbor provision of the U.S. Securities Litigation Reform Act of 1995, which reflect our current expectations regarding future events. Forward-looking statements include those relating to the public offering of the Company’ units, including as to the consummation of the offering described above, the expected proceeds from the offering, the intended use of proceeds and the timing of the closing of the offering and may include, but are not limited to statements preceded by, followed by, or that include the words “will,” “expects,” “believes,” “intends,” “would,” “could,” “may,” “anticipates,” and similar terms that relate to future events, performance, or our results. Forward-looking statements involve known and unknown risks and uncertainties, including those discussed in our Annual Report on Form 20-F, under the caption “Key Information – Risk Factors” filed with the relevant Canadian securities regulatory authorities in lieu of an annual information form and with the SEC, and other factors discussed under the heading “Risk Factors” in the Company’s Registration Statement on Form F-1 (File No. 333-232935) filed with the SEC and other documents subsequently filed with or furnished to the SEC. Known and unknown risks and uncertainties could cause our actual results to differ materially from those in forward-looking statements. Such risks and uncertainties include, among others, our ability to raise capital and obtain financing to continue our currently planned operations, our ability to regain compliance with the continued listing requirements of the NASDAQ and continue to list our Common Shares on the NASDAQ, our ability to continue as a going concern is dependent, in part, on our ability to transfer cash from Aeterna Zentaris GmbH to Aeterna Zentaris and the U.S. subsidiary and secure additional financing, our now heavy dependence on the success of Macrilen™ (macimorelin) and related out-licensing arrangements and the continued availability of funds and resources to successfully commercialize the product, including our heavy reliance on the success of the License Agreement with Novo, the global instability due to the global pandemic of COVID-19, and its unknown potential effect on our planned operations, including studies, our ability to enter into out-licensing, development, manufacturing, marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect, our reliance on third parties for the manufacturing and commercialization of Macrilen™ (macimorelin), potential disputes with third parties, leading to delays in or termination of the manufacturing, development, out-licensing or commercialization of our product candidates, or resulting in significant litigation or arbitration, uncertainties related to the regulatory process, unforeseen global instability, including the instability due to the global pandemic of the novel coronavirus, our ability to efficiently commercialize or out-license Macrilen™ (macimorelin), our reliance on the success of the pediatric clinical trial in the European Union (“E.U.”) and U.S. for Macrilen™ (macimorelin), the degree of market acceptance of Macrilen™ (macimorelin), our ability to obtain necessary approvals from the relevant regulatory authorities to enable us to use the desired brand names for our product, our ability to successfully negotiate pricing and reimbursement in key markets in the E.U. for Macrilen™ (macimorelin), any evaluation of potential strategic alternatives to maximize potential future growth and shareholder value may not result in any such alternative being pursued, and even if pursued, may not result in the anticipated benefits, our ability to take advantage of business opportunities in the pharmaceutical industry, our ability to protect our intellectual property, and the potential of liability arising from shareholder lawsuits and general changes in economic conditions. Investors should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties. Given these uncertainties and risk factors, readers are cautioned not to place undue reliance on these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or applicable law.

Investor Contact:

Jenene Thomas
JTC Team
T (US): +1 (833) 475-8247
E: aezs@jtcir.com

Teladoc Health Completes Acquisition of InTouch Health, Creating Single Virtual Care Delivery Leader from Hospital to Home

Combined Company Enables Providers to Build Comprehensive Telemedicine Strategies

PURCHASE, NY, July 01, 2020 (GLOBE NEWSWIRE) — Teladoc Health, Inc. (NYSE: TDOC), the global leader in virtual care, today announced that it has completed its acquisition of Santa Barbara, Calif.-area based InTouch Health. With the integration of InTouch Health’s innovative telehealth capabilities linking providers to one another in complex medical environments, Teladoc Health will connect the care experience across in-patient, outpatient and home care settings, ensuring greater access to high quality care and better health outcomes. At a time when virtual care has never been more important, the company is now the only global end-to-end partner spanning the full spectrum from acute visits and chronic conditions management to complex specialty care and remote surgery.  

“As virtual care quickly becomes a necessity for all healthcare providers, the acquisition of InTouch Health positions us to lead this transformation in healthcare and be that single, integrated partner,” said Jason Gorevic, chief executive officer, Teladoc Health. “Doctors and hospitals need medical grade solutions and a unified virtual care strategy that can scale and grow with them. This acquisition makes Teladoc Health the first and only company to comprehensively deliver on that need.”

In the wake of the coronavirus pandemic, consumer openness to telemedicine has never been higher and nearly half of providers are now delivering care online or by phone. At the same time, nearly two-thirds of consumers say they want the care they receive in their communities and virtual care to work together. With a platform purpose-built for healthcare, the organizations bring unparalleled clinical quality, technological innovation and operational scale to uniquely meet needs both inside and outside the four walls of the healthcare system. Together, the company will support thousands of physician users, partnering with hundreds of hospitals and health systems around the globe.

“With both our longstanding clients and new partners that have come to us since the start of the pandemic, there is a seismic shift in the urgency and readiness of hospitals and physician practices large and small to virtualize now,” explained Joe DeVivo, president, Hospital & Health Systems, Teladoc Health. “Providers are seeking an enterprise virtual care approach. With our proven healthcare industry expertise and unified platform, we are delivering a better way to engage with patients at every point along their healthcare journey.”

Teladoc Health completed its acquisition of InTouch Health on July 1, 2020. Pursuant to the terms of the agreement as announced on January 12, 2020, the purchase price consists of approximately $150 million in cash and 4.6 million shares of Teladoc Health common stock.

Notice of Inducement Equity Awards
In connection with the acquisition of InTouch Health, and effective as of the closing date, Teladoc Health granted to 352 employees of InTouch Health restricted stock unit awards covering an aggregate of 46,669 shares of Teladoc Health common stock. These awards include grants to Mr. Joseph DeVivo and Dr. Yulun Wang of restricted stock unit awards covering 3,772 and 5,028 shares of Teladoc Health common stock, respectively. Dr. Wang received an award of 2,514 restricted stock units that vest based on continued service to Teladoc Health over the three years following the date of grant, with a prorated portion vesting earlier if his employment terminates, under certain conditions, within the 18 months following the closing date, and an award of 2,514 restricted stock units that vest in a single installment (subject to his continued employment) on the date that is 18 months following the closing date.  All other restricted stock unit awards are scheduled to vest based on continued service to Teladoc Health over two to three years following the date of grant.

Additionally, in connection with the acquisition of InTouch Health, and effective as of the closing date, Teladoc Health granted to Mr. Joseph DeVivo a stock option award covering an aggregate 9,227 shares of Teladoc Health common stock, which has an exercise price of $198.85 per share.  The stock option award will vest as to 33% of the award on the first anniversary of the date of grant, and, as to the remainder of the award, in 24 equal monthly installments thereafter, subject to continued service to Teladoc Health.  

The stock option and restricted stock unit awards were approved by the Compensation Committee of the Board of Directors of Teladoc Health and were granted under the Teladoc Health, Inc. 2017 Employment Inducement Incentive Award Plan as employment inducement awards pursuant to NYSE rules.

For more information, visit www.teladochealth.com

About Teladoc Health
Teladoc Health is transforming how people access and experience healthcare. Recognized as the world leader in virtual care, Teladoc Health directly delivers millions of medical visits across 175 countries each year through the Teladoc Health Medical Group and enables millions of patient and provider touchpoints for thousands of hospitals, health systems and physician practices globally. Ranked #1 among direct-to-consumer telehealth providers in the J.D. Power 2019 U.S. Telehealth Satisfaction Study and Best in KLAS for Virtual Care Platforms for 2020, Teladoc Health leverages more than a decade of expertise and real-time insights to meet the growing virtual care needs of consumers, healthcare professionals, employers and health plans. For more information, please visit www.teladochealth.com  or follow @TeladocHealth on Twitter.

Media Contacts:
Sarah Kossek
Golin
312-729-4113
skossek@golin.com

Courtney McLeod
Director of Communications 
914-265-6789
cmcleod@teladochealth.com

Investor Contact:
Patrick Feeley
914-265-7925
pfeeley@teladochealth.com  

Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “believe,” “project,” “estimate,” “expect,” “may,” “should,” “will” and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding future revenues, future earnings, future numbers of members or clients, litigation outcomes, regulatory developments, market developments, new products and growth strategies, and the effects of any of the foregoing on our future results of operations or financial conditions.
           
Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: (i) changes in laws and regulations applicable to our business model; (ii) changes in market conditions and receptivity to our services and offerings; (iii) results of litigation; (iv) the loss of one or more key clients; and (v) changes to our abilities to recruit and retain qualified providers into our network. For a detailed discussion of the risk factors that could affect our actual results, please refer to the risk factors identified in our SEC reports, including, but not limited to our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as filed with the SEC.

Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. 

Novartis resolves legacy litigation matters, finalizing settlement of speaker program litigation with Government in the US and positioning company for the future by fully scaling its next-generation digital engagement technologies

  • Company finalizes USD 678 million settlement relating to suit challenging speaker programs and other promotional events conducted from 2002 through 2011 in the US as well as USD 51.25 million related to the company’s support of certain independent charitable co-pay foundations from 2010 to 2014
  • As part of these settlements, Novartis has agreed to new corporate integrity obligations in the US through 2025
  • Novartis embarks on new approach to meet the educational needs of physicians by setting new standard through digitally enabled education programs to support better outcomes for patients

Basel, July 2, 2020 – Novartis has finalized its previously disclosed agreement with the US Attorney’s Office for the Southern District of New York, the New York State Attorney General, and relator Oswald Bilotta resolving a civil suit challenging speaker programs and other promotional events conducted from 2002 through 2011 by Novartis Pharmaceuticals Corporation in the US. As part of this settlement, Novartis will pay USD 678 million and has agreed to new corporate integrity obligations with the Office of Inspector General (OIG) of the US Department of Health & Human Services that will change how the company delivers peer-to-peer programs in the US. As it has done over the past several years, Novartis will continue to evolve its approach to peer-to-peer medical education. The company fully provisioned for this settlement in July 2019.

Novartis expects that its new initiatives will resonate more with the way people learn in the digital era. Consistent with its already substantial efforts to fully scale its next-generation digital engagement technologies, Novartis will transition its physician education programs predominantly to digital formats, and use paid external physicians only in limited circumstances. The use of digital tools will allow Novartis to offer rich and interactive content, in some cases including peer-to-peer instruction, which physicians can engage with at their convenience.

Vas Narasimhan, CEO of Novartis, said: “Today’s settlements are consistent with Novartis commitment to resolve and learn from legacy compliance matters. We are a different company today—with new leadership, a stronger culture, and a more comprehensive commitment to ethics embedded at the heart of our company. I have been clear that I never want us to achieve commercial success at the expense of our values—our values must always come first and are the foundation of everything we do. With these agreements we mark an important milestone on our journey to build trust with society as we continue reimagining medicine to improve and extend lives all around the world.”

While Novartis is moving away from the traditional speaker program model in the US, peer-to-peer medical education remains an important aspect of the Company’s educational objectives as it helps physicians keep pace with medical innovation and make prescription decisions in the best interest of patients. Since 2011, Novartis has enhanced its peer-to-peer medical education programs to meet the evolving expectations of the industry and stakeholders around the world. Going forward, Novartis will set the standard by embracing new, digitally enabled education programs that will support better outcomes for patients.

Novartis will transform its sponsored peer-to-peer medical education in the US by:

  • Transitioning predominantly to digital/virtual formats;
  • Significantly limiting the instances in which it pays external healthcare professionals (HCPs) to deliver education; and
  • Taking additional steps to comprehensively foster compliance, including eliminating the use of restaurants as venues.

In addition, Novartis has finalized its previously disclosed agreement with the US Department of Justice and the US Attorney’s Office for the District of Massachusetts to resolve an investigation related to the company’s support of certain independent charitable co-pay foundations (ICCFs) from 2010 to 2014. As part of this settlement, Novartis will pay USD 51.25 million and has agreed to additional corporate integrity obligations with OIG to further enhance its controls relating to its interactions with ICCFs. The company provisioned for this settlement.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “continues,” “positioning,” “for the future,” “next generation,” “embarks,” “will,” “continue to evolve,” “expects,” “efforts,” “commitment,” “expectations,” “committed,” “working,” “going forward,” “further enhance,” “potential,” “transitioning,” “taking additional steps,” or similar terms, or by express or implied discussions regarding future changes to Novartis sponsored peer-to-peer medical education in the US, and regarding agreements by Novartis to additional corporate integrity obligations with the Office of Inspector General of the US Department of Health & Human Services. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the future changes to Novartis sponsored peer-to-peer medical education in the US will be successfully implemented in any particular time frame, or at all, or achieve any or all of their intended goals and benefits. Neither can there be any guarantee that we will successfully implement or comply with the additional corporate integrity obligations agreed to with the OIG. Nor can there be any guarantee regarding the reactions of healthcare professionals, customers, strategic partners and other stakeholders to the future changes to Novartis sponsored peer-to-peer medical education in the US or the additional corporate integrity obligations. In particular, our expectations regarding such future changes to Novartis sponsored peer-to-peer medical education in the US and additional corporate integrity obligations could be affected by, among other things, potential adverse reactions to the planned changes to Novartis sponsored peer-to-peer medical education in the US and additional corporate integrity obligations by healthcare professionals, customers, strategic partners or other stakeholders; the potential that the benefits expected from the planned changes to Novartis sponsored peer-to-peer medical education in the US may not be realized or may take longer to realize than expected; potential or actual failures to comply with the additional corporate integrity obligations; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of more than 145 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.

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BeiGene Announces Acceptance of a Supplemental New Drug Application for Tislelizumab in Patients with Previously Treated Unresectable Hepatocellular Carcinoma in China

BEIJING, China and CAMBRIDGE, Mass., July 01, 2020 (GLOBE NEWSWIRE) — BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental new drug application (sNDA) of BeiGene’s anti-PD-1 antibody tislelizumab for the treatment of patients with previously treated unresectable hepatocellular carcinoma (HCC), the most common form of liver cancer.

“We are excited by the acceptance of our first filing for tislelizumab in liver cancer,” commented Xiaobin Wu, Ph.D., General Manager of China and President of BeiGene. “Half of the world’s liver cancer patients reside in China, and there is a significantly unmet medical need. We will continue our communications with the CDE and hope to bring these patients a viable treatment option in the near future.” 

The sNDA is supported by clinical results from a pivotal Phase 2 trial of tislelizumab in patients with previously treated unresectable HCC (NCT03419897). The study enrolled 249 patients with unresectable HCC from eight countries and regions in Asia and Europe, including 138 patients who received one line of prior systemic therapy and 111 patients who received at least two lines of prior therapies. Patients received tislelizumab monotherapy (200 mg every three weeks) and the primary endpoint of the trial was objective response rate as assessed by independent review committee (IRC). Results of this study will be presented at an upcoming medical conference.

About Hepatocellular Carcinoma

HCC is a major global health problem, accounting for 85-90 percent of all reported cases of liver cancer.1 Liver cancer is the sixth most common type of cancer, with an estimated 841,080 new cases in 2018 worldwide;2 it was also the fourth most common cause of cancer-related mortality, responsible for an estimated 781,631 deaths in 2018.3 China accounts for approximately 50 percent of both new HCC cases and HCC-related deaths worldwide in 2018. 4

About Tislelizumab

Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

Tislelizumab is approved by the China National Medical Products Administration (NMPA) as a treatment for patients with classical Hodgkin’s lymphoma who received at least two prior therapies and for patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

In addition, three supplemental new drug applications (sNDAs) for tislelizumab have been accepted by the Center for Drug Evaluation (CDE) of the NMPA and are under review, for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy, for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and for previously treated unresectable hepatocellular carcinoma.

Currently, 16 potentially registration-enabling clinical trials are being conducted in China and globally, including 12 Phase 3 trials and four pivotal Phase 2 trials.

Tislelizumab is not approved for use outside of China.

About the Tislelizumab Clinical Program

Clinical trials of tislelizumab include:

  • Phase 3 trial in patients with locally advanced or metastatic urothelial carcinoma (NCT03967977);
  • Phase 3 trial comparing tislelizumab with docetaxel in the second- or third-line setting in patients with NSCLC (NCT03358875);
  • Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced squamous NSCLC (NCT03594747);
  • Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced non-squamous NSCLC (NCT03663205);
  • Phase 3 trial of tislelizumab in combination with platinum-based doublet chemotherapy as neoadjuvant treatment for patients with NSCLC (NCT04379635);
  • Phase 3 trial of tislelizumab combined with platinum and etoposide versus placebo combined with platinum and etoposide in patients with extensive-stage small cell lung cancer (NCT04005716);
  • Phase 3 trial comparing tislelizumab with sorafenib as first-line treatment for patients with hepatocellular carcinoma (HCC; NCT03412773);
  • Phase 2 trial in patients with previously treated unresectable HCC (NCT03419897);
  • Phase 3 trial comparing tislelizumab with chemotherapy as second-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC; NCT03430843);
  • Phase 3 trial of tislelizumab in combination with chemotherapy as first-line treatment for patients with ESCC (NCT03783442);
  • Phase 3 trial of tislelizumab versus placebo in combination with chemoradiotherapy in patients with localized ESCC (NCT03957590);
  • Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment for patients with gastric cancer (NCT03777657);
  • Phase 2 trial in patients with MSI-H/dMMR solid tumors (NCT03736889); and
  • Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment in patients with nasopharyngeal cancer (NCT03924986).

About BeiGene

BeiGene is a global, commercial-stage biotechnology company focused on discovering, developing, manufacturing, and commercializing innovative medicines to improve treatment outcomes and access for patients worldwide. Our 3,800+ employees in China, the United States, Australia, and Europe are committed to expediting the development of a diverse pipeline of novel therapeutics for cancer. We currently market two internally-discovered oncology products: BTK inhibitor BRUKINSA® (zanubrutinib) in the United States and China, and anti-PD-1 antibody tislelizumab in China. We also market or plan to market in China additional oncology products licensed from Amgen Inc., Celgene Logistics Sàrl, a Bristol Myers Squibb (BMS) company, and EUSA Pharma. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneUSA.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeiGene’s further advancement of, and anticipated clinical development, regulatory milestones and commercialization of tislelizumab. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene’s ability to achieve commercial success for its marketed products and drug candidates, if approved; BeiGene’s ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene’s reliance on third parties to conduct drug development, manufacturing and other services; BeiGene’s limited operating history and BeiGene’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; the impact of the COVID-19 pandemic on the Company’s clinical development, commercial and other operations, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

Investor Contact 
Craig West
+1 857-302-5189
ir@beigene.com

Media Contact 
Liza Heapes or Vivian Ni
+1 857-302-5663 or +1 857-302-7596
media@beigene.com

___________________________

1 Nordenstedt H, White DL, El-Serag HB. The changing pattern of epidemiology in hepatocellular carcinoma. Digestive and Liver Disease. 2010;42(Suppl 3):S206-S214. doi:10.1016/S1590-8658(10)60507-5.

2 Global Cancer Observatory 2018: https://gco.iarc.fr/today/online-analysis-table?v=2018&mode=cancer&mode_population=countries&population=900&populations=900&key=asr&sex=0&cancer=39&type=0&statistic=5&prevalence=0&population_group=0&ages_group%5B%5D=0&ages_group%5B%5D=17&group_cancer=1&include_nmsc=1&include_nmsc_other=1

3 Global Cancer Observatory 2018: https://gco.iarc.fr/today/online-analysis-table?v=2018&mode=cancer&mode_population=countries&population=900&populations=900&key=asr&sex=0&cancer=39&type=1&statistic=5&prevalence=0&population_group=0&ages_group%5B%5D=0&ages_group%5B%5D=17&group_cancer=1&include_nmsc=1&include_nmsc_other=1

4 Global Cancer Observatory 2018: https://gco.iarc.fr/today/online-analysis-table?v=2018&mode=population&mode_population=countries&population=900&populations=900&key=asr&sex=0&cancer=11&type=0&statistic=5&prevalence=0&population_group=0&ages_group%5B%5D=0&ages_group%5B%5D=17&group_cancer=1&include_nmsc=1&include_nmsc_other=1

Chembio to Report COVID-19 Product Development Plans and Preliminary Estimated Second Quarter 2020 Revenue Results

Press Releases to be Issued on July 6, and Conference Call to be Held on July 7

HAUPPAUGE, N.Y., July 01, 2020 (GLOBE NEWSWIRE) — Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading global point-of-care diagnostic company focused on infectious diseases, today announced today that it will issue, after the U.S. financial markets close on Monday, July 6, 2020, press releases with respect to its current plans for COVID-19 product development and regulatory approvals and its preliminary estimates of revenue results for the quarter ended June 30, 2020.

Chembio will host a conference call on Tuesday, July 7, 2020, at 8:00 am (Eastern time) to discuss the information described in those press releases and related business and financial matters. Interested parties can participate in the conference call by dialing 877-407-0778 (U.S. toll-free) or 201-689-8565 (international) or joining a live audio webcast available at www.chembio.com/investors/calendar-of-events/. Following the call, a replay of the call is expected to be available through July 10, 2020, by dialing 877-481-4010 (U.S. toll-free) or 919-882-2331 (international), conference ID code 35572, or by accessing  www.chembio.com/investors/calendar-of-events/.

About Chembio Diagnostics
Chembio is a leading point-of-care diagnostics company focused on detecting and diagnosing infectious diseases, including COVID-19, sexually transmitted disease, and fever and tropical disease. The company’s proprietary DPP technology platform, which uses a small drop of blood from the fingertip or alternative sample types, provides high-quality, cost-effective results in approximately 15 minutes. Coupled with Chembio’s extensive scientific expertise, its novel DPP technology offers broad market applications beyond infectious disease. Chembio’s products are sold globally, directly and through distributors, to hospitals and clinics, physician offices, clinical laboratories, public health organizations, government agencies, and consumers. Learn more at www.chembio.com.

DPP is Chembio’s registered trademark. For convenience, this trademark appears in this release without ® symbols, but that practice does not mean that Chembio will not assert, to the fullest extent under applicable law, its rights to the trademark.

Contact:
Philip Taylor
Gilmartin Group
(415) 937-5406
investor@chembio.com

Catalyst Biosciences Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

SOUTH SAN FRANCISCO, Calif., July 01, 2020 (GLOBE NEWSWIRE) — Catalyst Biosciences, Inc. (NASDAQ: CBIO) today reported that the Compensation Committee of Catalyst’s Board of Directors granted a non-qualified inducement stock option to purchase an aggregate of 140,000 shares of Catalyst’s common stock to Clinton Musil, Catalyst’s recently appointed Chief Financial Officer, effective July 1, 2020.

The stock option was granted as an inducement material to Mr. Musil’s entering into employment with Catalyst in accordance with Nasdaq Listing Rule 5635(c)(4). The stock option was granted outside of Catalyst’s 2018 Omnibus Incentive Plan, but except as set forth in the stock option agreement, will generally be subject to the same terms and conditions as apply to stock options granted under the plan.

The stock option will vest with respect to 25% of the shares underlying the stock option one year after Mr. Musil’s employment start date, and the remaining 75% of the shares underlying the stock option will vest in equal monthly installments over the 36-month period following the one-year anniversary of Mr. Musil’s employment start date, subject to his continued service to Catalyst through each relevant vesting date. Notwithstanding the foregoing, the stock option will accelerate upon certain terminations of employment, including within a certain period following a change in control transaction. The stock option has a ten-year term and an exercise price of $5.88 per share, which is equal to the closing price of Catalyst’s common stock on July 1, 2020.

About Catalyst Biosciences
Catalyst is a research and clinical development biopharmaceutical company focused on addressing unmet needs in rare hematologic and complement-mediated disorders. Our protease engineering platform includes two late-stage clinical programs in hemophilia; a research program on engineering of subcutaneous (SQ) complement inhibitors; and a partnered preclinical development program with Biogen for dry age-related macular degeneration (AMD). The product candidates generated by our protease engineering platform have improved functionality and potency that allow for: SQ administration of recombinant coagulation factors and complement inhibitors; low-dose, high activity gene therapy constructs; and less frequently dosed intravitreal therapeutics. Our most advanced product candidate is marzeptacog alfa (activated) (MarzAA), a next-generation SQ FVIIa entering a Phase 3 registration study in late 2020. Our next most advanced product candidate is dalcinonacog alfa (DalcA), a next-generation SQ FIX, which has demonstrated efficacy and safety in a Phase 2b clinical trial in individuals with Hemophilia B. We have a discovery stage Factor IX gene therapy construct – CB 2679d-GT – for Hemophilia B, that has demonstrated superiority compared with the Padua variant in preclinical models. Finally, we have a global license and collaboration agreement with Biogen for the development and commercialization of anti-complement Factor 3 (C3) pegylated CB 2782.

Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements about the potential benefits of products based on Catalyst’s engineered protease platform, plans to enter into a Phase 3 registration study of MarzAA in late 2020, the potential for MarzAA and DalcA to effectively and therapeutically treat hemophilia subcutaneously, the superiority of CB 2679d-GT over other gene therapy candidates and the Company’s collaboration with Biogen for the development and commercialization of pegylated CB 2782 for the potential treatment of geographic atrophy-associated dry age-related macular degeneration. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially, including, but not limited to, the risk that trials and studies may be delayed as a result of the COVID-19 virus and other factors, that trials may not have satisfactory outcomes, that additional human trials will not replicate the results from earlier trials, that potential adverse effects may arise from the testing or use of DalcA or MarzAA, including the generation of neutralizing antibodies, which has been observed in patients treated with DalcA, the risk that costs required to develop or manufacture the Company’s products will be higher than anticipated, including as a result of delays in development and manufacturing resulting from COVID-19 and other factors, the risk that Biogen will terminate Catalyst’s agreement, competition and other risks described in the “Risk Factors” section of the Company’s quarterly report filed with the Securities and Exchange Commission on May 11, 2020, and in other filings with the Securities and Exchange Commission. The Company does not assume any obligation to update any forward-looking statements, except as required by law.

Contact:
Ana Kapor
Catalyst Biosciences, Inc.
investors@catbio.com 

Smile Direct Club Continues Strategic Growth Via International Expansion

Teledentistry leader further expands access to care with entrance into Singapore, Austria, and reopens in Germany

NASHVILLE, Tenn., July 01, 2020 (GLOBE NEWSWIRE) — SmileDirectClub, Inc. (Nasdaq: SDC), the first direct-to-consumer telehealth platform for teeth straightening, announced today its continued international expansion with openings in Singapore and Austria. Entrance into these markets will further extend the Company’s international footprint following its successful launches in the United Kingdom, Ireland, Australia, New Zealand, and Hong Kong in 2019 and Canada in 2018. Additionally, the Company is reopening in Germany, and plans to launch into new regions throughout Europe, Latin America, Asia Pacific and more in 2020.

“We have built a robust international infrastructure and will continue to seek opportunities to reach consumers around the world. Markets outside of the U.S. present a great opportunity for our business, and we look forward to helping people in Austria and Singapore get a smile they love,” said Kay Oswald, President of International at SmileDirectClub. “Our mission is to provide high-quality affordable and convenient access to care to as many people as possible. We are pleased to extend this to people in these markets, as well as invest in these local economies.”

Customers seeking SmileDirectClub’s clear aligner therapy treatment can book a free appointment to capture a 3D image of their teeth at a SmileShop where applicable, or use doctor prescribed impression kits, which are mailed directly to the home, to capture a mould of their teeth. SmileDirectClub’s clear aligner therapy treatment is prescribed, directed, and managed by an affiliated dentist or orthodontist registered and licensed to practice in that country throughout the entire process from initial diagnosis to completion. In order to uphold the highest quality of care, SmileDirectClub has partnered with lead dentists Dr. Samintharaj Kumar, the Chief Executive Officer of Nuffield Dental Holdings; Dr. Christine Dirxen; and Dr. István Joó, to oversee the clinical practices in Singapore, Germany, and Austria respectively.

SmileDirectClub’s first Singapore SmileShop located in HarbourFront Centre is now open, and the Austria SmileShops located in Vienna are slated to open in early July. SmileDirectClub is continuing its strategic global expansion plans as permitted by local guidelines and mandates as the world begins to lift restrictions arising from the COVID 19 pandemic.

Since launching in the U.S. in 2014, SmileDirectClub has become one of the fastest-growing health technology companies, serving over one million customers around the world.

About SmileDirectClub
SmileDirectClub, Inc. (Nasdaq: SDC) (“SmileDirectClub”) is an oral care company and creator of the first direct-to-consumer medtech platform for teeth straightening, now also offered directly via dentist and orthodontists’ offices. Through our cutting-edge teledentistry technology and vertically integrated model, we are revolutionizing the oral care industry, from clear aligner therapy to our affordable, premium oral care product line. SmileDirectClub’s mission is to democratize access to a smile each and every person loves by making it affordable and convenient for everyone. SmileDirectClub is headquartered in Nashville, Tennessee and operates in the U.S., Canada, Australia, New Zealand, United Kingdom, Ireland, Germany, Hong Kong and Singapore. For more information, please visit SmileDirectClub.com.

Contact:
SmileDirectClub Media Relations: Press@SmileDirectClub.com