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Sinovac Reports Unaudited Third Quarter 2020 Financial Results

BEIJING–(BUSINESS WIRE)–
Sinovac Biotech Ltd. (NASDAQ: SVA) (“Sinovac” or the “Company”), a leading provider of biopharmaceutical products in China, announced today its unaudited financial results for the third quarter ended September 30, 2020.

Third Quarter and Nine Months Ended 2020 Financial Summary

• Sales for the third quarter of 2020 were $115.5 million, an increase of 79.4% from $64.3 million in the prior year period.

• Sales for the nine months ended September 30, 2020, were $183.2 million, an increase of 11.1% from $164.9 million in the prior year period.

• Operating income for the third quarter of 2020 increased by 101.7% from the prior year period due to higher sales.

• Operating income for the nine months ended September 30, 2020, decreased by 52.9% from the prior year period due to higher R&D expenses.

• The Company posted net income attributable to common shareholders of $9.6 million, or $0.10 per basic and diluted share, in the third quarter of 2020, compared to net income attributable to common shareholders of $6.3 million, or $0.06 per basic and diluted share, in the prior year period.

• The Company posted net loss attributable to common shareholders of $3.0 million, or loss of $0.03 per basic and diluted share, for the nine months ended September 30, 2020, compared to net income attributable to common shareholders of $18.1 million, or $0.19 per basic and diluted share, in the prior year period.

Mr. Weidong Yin, Chairman, President, and CEO of Sinovac, commented, “We are pleased to report strong performance during the third quarter of 2020 with growth in sales and net income. Sales activities in China’s vaccine market returned to normal as the number of reported COVID-19 cases was dramatically reduced due to strict lockdown measures implemented by the government. Consequently, all of our commercialized product sales rebounded in the third quarter on a sequential and year-over-year basis. In particular, as we entered flu season for 2020-2021, demand for the flu vaccine was stronger than previous years due to the COVID-19 outbreak.”

“Our research and development team also made great strides this year. In addition to Chinese market approval of our varicella vaccine and quadrivalent influenza vaccine (QIV), we made significant progress in the development and regulatory advancement of our Sabin inactivated polio vaccine (sIPV) and 23-valent pneumococcal polysaccharide vaccine (PPV-23).

“Sinovac is at the forefront of the fight against COVID-19 through vaccine development. Our COVID-19 vaccine, or CoronaVac, is currently being tested in phase III clinical trials in Brazil, Indonesia, Turkey and Chile,” Mr. Yin continued. “We have also forged a strategic partnership with Sino Biopharmaceutical Limited (“Sino Biopharm”) with respect to our R&D subsidiary’s development of CoronaVac, which will accelerate our efforts to help combat the global pandemic.”

Business Highlights

Marketing and Sales

In the third quarter of 2020, the Company’s business returned to normal following the impact of the COVID-19 outbreak in the first half of 2020. Demand for vaccine products was strong due to the surge in vaccination activities, following a pause in the first half of 2020, and the distribution channel’s inventories were replenished. In particular, demand for the flu vaccine was significantly higher compared to the prior year due to the COVID-19 outbreak.

Pipeline Development

COVID-19 Vaccine – The Company initiated the development of an inactivated vaccine against COVID-19 (named CoronaVac) on January 28, 2020. The phase I and II human studies on healthy adults aged 18 to 59 and elderly adults aged 60 and above were conducted in China and enrolled 144 participants in the phase I trial and 600 participants in the phase II trial, with 743 participants receiving at least one dose of investigational product. Results from the randomized, double-blind, placebo-controlled phase I/II clinical trial on safety, tolerability and immunogenicity of CoronaVac were published in The Lancet Infectious Diseases on November 17, 2020.

The phase I trial was conducted in a dose-escalating manner, in which participants were randomly separated 1:1 into two vaccination schedule cohorts, the days 0 and 14 cohort and days 0 to 28 cohort, and then randomly assigned to blocks within each cohort of low-dose CoronaVac (3 μg) or high-dose CoronaVac (6 μg). Within each block, participants were randomly assigned 2:1 to either two doses of CoronaVac or placebo. In the phase II trial, at screening, participants were randomly separated 1:1 into the same two vaccination schedule cohorts and then randomly assigned 2:2:1 to receive two doses of either low-dose CoronaVac, high-dose CoronaVac, or placebo. The study found that two doses of CoronaVac at different concentrations and using different dosing schedules were well tolerated and moderately immunogenic in healthy adults aged 18–59 years.

CoronaVac was well tolerated and induced neutralizing antibodies against COVID, which supported the approval of emergency use of CoronaVac in China. The Company is currently conducting phase I and II studies on adolescents in China, as well as phase III trials in Brazil, Indonesia, Turkey, and Chile.

Taking safety, immunogenicity, and production capacity into account, the 3 μg dose of CoronaVac is the suggested dose for efficacy assessment in future trials, with ongoing trials investigating on the day 0 and 14 vaccination schedule, and future phase III clinical trials investigating on the day 0 and 28 vaccination schedule. The protective efficacy of CoronaVac remains to be determined.

Sabin Inactivated Polio vaccine (“sIPV”) – The Company submitted an application to the National Medical Products Administration (NMPA) for the product license of sIPV in January 2019, which is expected to be granted in the beginning of 2021.

23-valent pneumococcal polysaccharide vaccine (“PPV”) – The Company completed site inspection for PPV in June 2020. The commercial launch of PPV in the Chinese market is expected in early 2021.

Unaudited Financial Results for Third Quarter 2020

In the third quarter of 2020, the Company’s regular business operations began to recover from the impact of the COVID-19 outbreak. As a result, sales for the third quarter of 2020 increased by 79.4% to $115.5 million from $64.3 million in the prior year period.

Gross profit in the third quarter of 2020 was $101.3 million, compared to a gross profit of $54.0 million in the prior year period. Gross margin was 87.8%, compared to 83.9% in the prior year period. Gross margin increased in the third quarter of 2020 reflects changes in sales mix compared to the comparative period.

Selling, general and administrative expenses in the third quarter of 2020 increased by 37.3% to $47.2 million from $34.4 million in the prior year period. The Company incurred higher selling expenses due to an increase in sales.

R&D expenses in the third quarter of 2020 were $26.0 million, compared to $5.7 million in the prior year period, as the Company continued to invest in its product pipeline including sIPV and PPV, as well as research and development of the COVID-19 vaccine.

Net income in the third quarter of 2020 was $21.2 million, compared to net income of $11.7 million in the prior year period, due to an increase in sales.

Net income attributable to common shareholders was $9.6 million, or $0.10 per basic and diluted share, compared to net income attributable to common shareholders of $6.3 million, or $0.06 per basic and diluted share, in the prior year period.

As the Company announced on February 22, 2019, its Board of Directors determined that certain shareholders became “Acquiring Persons,” as defined in the Company’s Rights Agreement (“Rights Agreement”), and a “Trigger Event” occurred under the Rights Agreement. As a result, new common and preferred shares of the Company were issued into a trust for the benefit of the Company’s shareholders who did not trigger the Rights Plan. Excluding the effect of the “Trigger Event” and the newly issued common and preferred shares, basic and diluted earnings per share for the third quarter of 2020, would have been $0.16.

Non-GAAP adjusted EBITDA was $36.1 million in the third quarter of 2020, compared to $15.8 million in the prior year period. Non-GAAP net income in the third quarter of 2020 was $29.3 million, compared to $12.5 million in the prior year period. Non-GAAP diluted earnings per share in the third quarter of 2020 was $0.10, compared to earnings of $0.07 per share in the prior year period. Non-GAAP diluted loss per share in the third quarter of 2020 excluding the effect of the “Trigger Event” and the newly issued common and preferred shares would have been $0.16. Reconciliations of non-GAAP measures to the nearest comparable GAAP measures are included at the end of this earnings announcement.

Unaudited Financial Results for Nine Months Ended September 30, 2020

Sales for the nine months ended September 30, 2020, were $183.2 million, an increase of 11.1% from $164.9 million in the prior year period.

Gross profit for the nine months ended September 30, 2020, was $159.5 million, compared to a gross profit of $144.7 million in the prior year period. Gross margin was 87.1%, compared to 87.7% in the prior year period.

Selling, general and administrative expenses for the nine months ended September 30, 2020, were $93.5 million, compared to $88.2 million in the prior year period. The Company incurred higher selling expenses due to an increase in sales.

R&D expenses for the nine months ended September 30, 2020, were $46.1 million, compared to $16.5 million in the prior year period, as the Company continued to invest in its product pipeline, including sIPV and PPV, as well as research and development of the COVID-19 vaccine.

Net income for the nine months ended September 30, 2020, was $12.5 million, compared to $32.4 million in the prior year period. The decrease in net income was primarily due to higher R&D expenses.

Net loss attributable to common shareholders was $3.0 million, or loss of $0.03 per basic and diluted share, compared to net income attributable to common shareholders of $18.1 million, or $0.19 per basic and diluted share, in the prior year period.

Excluding the effect of the “Trigger Event” under the Rights Agreement, as described above, and the newly issued common and preferred shares, basic and diluted earnings per share for the nine months ended September 30, 2020, would be $0.02.

Non-GAAP adjusted EBITDA was $31.0 million for the nine months ended September 30, 2020, compared to $45.6 million in the prior year period. Non-GAAP net income for the nine months ended September 30, 2020, was $21.8 million, compared to $34.5 million in the prior year period. Non-GAAP diluted loss per share for the nine months ended September 30, 2020 was $0.02, compared to an earnings of $0.21 per share in the prior year period. Non-GAAP diluted earnings per share for the nine months ended September 30, 2020, excluding the effect of the “Trigger Event” and the newly issued common and preferred shares, would be $0.04. Reconciliations of non-GAAP measures to the nearest comparable GAAP measures are included at the end of this earnings announcement.

As of September 30, 2020, cash and cash equivalents were $150.2 million, compared to $152.7 million as of December 31, 2019. In the nine months ended September 30, 2020, net cash used in operating activities was $1.8 million, net cash used in investing activities was $52.6 million, and net cash provided by financing activities was $50.9 million. As of September 30, 2020, the Company had $30.3 million of bank loans due within one year. The Company expects that its current cash position will be able to support its operations for at least the next 12 months.

The Company’s Interim Financial Statements are prepared and presented in accordance with U.S. GAAP. However, the Interim Financial Statements have not been audited or reviewed by the Company’s independent registered accounting firm.

Legal Proceedings

As previously disclosed by the Company, on March 13, 2018, 1Globe Capital LLC (“1Globe”) filed a complaint against the Company in the Antigua Court. The trial of the matter took place from December 3 to 5, 2018. On December 19, 2018, the Antigua judge handed down his judgment (the “Antigua Judgment”), finding in the Company’s favor in full, dismissing 1Globe’s claim and declaring that the Rights Agreement was validly adopted as a matter of Antigua law. On January 29, 2019, 1Globe filed a Notice of Appeal against the Antigua Judgment. On March 4, 2019, 1Globe filed an application for urgent interim relief, seeking an injunction to prevent the Company from continuing to implement its Rights Agreement until the resolution of the appeal. This application was heard on April 4, 2019, at which the Court of Appeal issued an order restraining the Company from operating the Rights Agreement in any way that affects 1Globe’s rights or shareholding or otherwise distributing the exchange shares to the Company’s shareholders who did not trigger the Rights Plan until after the determination of the appeal (the “Exchange Shares”). 1Globe’s appeal against the Antigua Judgment was heard on September 18, 2019, and the appeal decision is now pending.

As disclosed previously, on March 5, 2018, the Company filed a lawsuit in the Court of Chancery of the State of Delaware seeking a determination whether 1Globe, the Chiang Li Family, OrbiMed Advisors, LLC and certain other shareholders of the Company had triggered the Rights Agreement. On April 12, 2018, 1Globe filed an amended answer to the Company’s complaint, counterclaims, and a third-party complaint against the Company and Mr. Weidong Yin alleging, among other allegations, that the Rights Agreement is not valid. On March 6, 2019, the Delaware Chancery Court entered a status quo order providing that the Company not distribute any of the Exchange Shares to the Company’s shareholders who did not trigger the Rights Plan until the final disposition of the pending Delaware litigation or further order of the Court. On April 8, 2019, the Delaware Chancery Court stayed the Delaware litigation pending the outcome of 1Globe’s appeal of the Antigua Judgment.

Separately, Heng Ren Investments LP (“Heng Ren”) filed suit against Sinovac and Weidong Yin for alleged breach of fiduciary duties and wrongful equity dilution on May 31, 2019, in Massachusetts state court. Sinovac removed the matter from state court to the United States District Court for the District of Massachusetts. Heng Ren alleged that Mr. Yin breached fiduciary duties owed to minority shareholders, that Sinovac aided and abetted breaches of fiduciary duties, and that both Sinovac and Mr. Yin engaged in wrongful equity dilution. Heng Ren requested damages, attorneys’ fees, and prejudgment interest. On September 14, 2020, the Company filed a motion to dismiss Heng Ren’s claims and the court’s decision on that motion is pending.

Status of Exchange Shares and Trading in the Company’s Shares

As a result of the pending legal proceedings described above, the Exchange Shares are expected to remain in a trust for the benefit of the Company’s shareholders who did not trigger the Rights Plan until, at least, the conclusion of the appeal against the Antigua Judgment and final disposition of the Delaware litigation or further order of the Delaware Chancery Court. The Exchange Shares remain issued and outstanding. The Nasdaq Stock Market LLC implemented a halt on trading of the Company’s common shares at the time of issuance of the Exchange Shares to the trust and the Company is currently unable to estimate when trading will resume.

Recent Developments

In December 2020, Sinovac Life Sciences Co., Ltd. (“Sinovac LS”), a subsidiary of Sinovac, secured funding for further development, capacity expansion and manufacturing of the CoronaVac, as well as to conduct other development and operational activities. Sino Biopharmaceutical Limited (“Sino Biopharm”), a Hong Kong Stock Exchange listed company (1177.HK), through its subsidiary Talent Forward Limited, invested approximately US$500 million in exchange for approximately 15% of the total equity interest of Sinovac LS. An affiliate of Sino Biopharm also made an immaterial investment in Sinovac LS. Sino Biopharm is a leading innovative research and development driven pharmaceutical conglomerate in China. Prior to the investment, each of Advantech Capital and Vivo Capital exercised its right to convert its convertible loan previously announced by the Company on May 22, 2020 into 7.5% of the total equity interests of Sinovac LS, which after the investment now represents an approximately 6.3% stake in Sinovac LS. Sinovac also previously granted the CoronaVac development team incentive awards to acquire approximately 15% of equity interests in Sinovac LS (at the time of grant) under an employee incentive plan, and, as the milestones underlying the incentive awards were achieved, such incentive awards were exercised.

About Sinovac

Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacturing and commercialization of vaccines that protect against human infectious diseases. Sinovac’s product portfolio includes vaccines against enterovirus71 (EV71), hepatitis A and B, seasonal influenza, Quadrivalent Influenza vaccine (“QIV”), H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), varicella vaccine and mumps. Healive, the hepatitis A vaccine manufactured by the Company, has passed the assessment under WHO prequalification procedures in 2017. The EV71 vaccine, an innovative vaccine developed by Sinovac against hand foot and mouth disease caused by EV71, was commercialized in China in 2016. In 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine, which it has supplied to the Chinese Government’s vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the government stockpiling program. The Company is developing a number of new products including a Sabin-strain inactivated polio vaccine, pneumococcal polysaccharides vaccine, and CoronaVac, its COVID-19 vaccine candidate. Sinovac primarily sells its vaccines in China, while also exploring growth opportunities in international markets. The Company is registering its products in over 30 countries outside of China. For more information please see the Company’s website at www.sinovac.com.

Safe Harbor Statement

This announcement may include certain statements that are not descriptions of historical facts, but are forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Forward-looking statements involve risks, uncertainties and other factors that could cause actual results to differ materially from those contained in any such statements. In particular, the outcome of any litigation is uncertain, and the Company cannot predict the potential results of the litigation it filed or that could be filed against it by others. Additionally, the triggering of a shareholder rights plan is nearly unprecedented, and the Company cannot predict the impact on the Company or its stock price as a result of the trigger of the rights plan.

This announcement contains forward-looking information about the Company’s efforts to develop a potential COVID-19 vaccine that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with clinical data (including the Phase III trial data); the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase III trials or in larger, more diverse populations upon commercialization; the risk that clinical trial data are subject to differing interpretations and assessments, and by regulatory authorities; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or have access to logistics or supply channels commensurate with global demand for any potential approved vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine candidate; uncertainties regarding the ability to obtain recommendations public health authorities; uncertainties regarding the impact of COVID-19 on our business, operations and financial results; and competitive developments.

Non-GAAP Financial Measures

To supplement its consolidated financial statements, which are prepared and presented in accordance with GAAP, Sinovac uses the following non-GAAP financial measures: non-GAAP adjusted EBITDA, non-GAAP net income and non-GAAP diluted EPS. For more information on these non-GAAP financial measures, please refer to the table captioned “Reconciliations of non-GAAP Measures to the Nearest Comparable GAAP Measures” in this results announcement.

Sinovac believes that non-GAAP adjusted EBITDA, non-GAAP net income and non-GAAP diluted EPS help identify underlying trends in its business that could otherwise be distorted by the effect of certain income or expenses that Sinovac includes net income and diluted EPS. Sinovac believes that non-GAAP adjusted EBITDA, non-GAAP net income and non-GAAP diluted EPS provide useful information about its core operating results, enhance the overall understanding of its past performance and future prospects and allow for greater visibility with respect to key metrics used by our management in its financial and operational decision-making. Non-GAAP adjusted EBITDA, non-GAAP net income and non-GAAP diluted EPS should not be considered in isolation or construed as an alternative to income from operations, net income, diluted EPS, or any other measure of performance or as an indicator of Sinovac’s operating performance. These non-GAAP financial measures presented here may not be comparable to similarly titled measures presented by other companies. Other companies may calculate similarly titled measures differently, limiting their usefulness as comparative measures to our data.

Non-GAAP adjusted EBITDA represents net income and excludes interest and financing expenses, interest income, net other income (expenses) and income tax benefit (expenses), and certain non-cash expenses, consisting of share-based compensation expenses, amortization and depreciation that Sinovac does not believe are reflective of the core operating performance during the periods presented.

Non-GAAP net income represents net income before share-based compensation expenses, and foreign exchange gain or loss.

Non-GAAP diluted EPS represents non-GAAP net income (loss) attributable to common shareholders divided by the weighted average number of shares outstanding during the periods on a diluted basis, including accounting for the effect of the assumed conversion of options.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201207005375/en/

Sinovac Biotech Ltd.

Helen Yang

Tel: +86-10-8279-9871

Fax: +86-10-6296-6910

Email: [email protected]

ICR Inc.

Bill Zima

U.S.: 1-646-308-1707

Email: [email protected]

KEYWORDS: China Asia Pacific

INDUSTRY KEYWORDS: Infectious Diseases Biotechnology Pharmaceutical Health

MEDIA:

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Alnylam Issues 2nd Annual Patient Access Philosophy Report Highlighting Broad Access to the Company’s Approved Therapies

− Company Also Introduces Inaugural ‘Rare Disease Trend Report’ Providing Insights Gleaned Through Interviews and Research with Payers −

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today published two new reports: the second annual update on its Patient Access Philosophy and its first-ever Rare Disease Trend Report. Together, the reports illuminate both the strategies by which the company has been able to maximize access for its approved medicines around the world, and the barriers associated with coverage for rare disease therapies.

The Patient Access Philosophy Report

The 2020 Patient Access Philosophy Report reflects Alnylam’s progress advancing its stated 2017 Patient Access Philosophy. The 2020 report highlights the Company’s efforts to support patients in gaining access to needed medicines, both before and during the COVID-19 pandemic. It also provides updates on initiatives to deliver strong value to payers in the face of increasing barriers to access for rare disease medicines.

Highlights include:

Rapid, affordable access to treatment: For people experiencing debilitating diseases like hATTR amyloidosis, acute hepatic porphyria or primary hyperoxaluria type 1, waiting for a therapy that could change their lives is unacceptable. In collaboration with payers around the world, Alnylam has:

• Realized greater than 98% coverage for ONPATTRO and nearly 94% for GIVLAARI across U.S. commercial and government insurers, including Medicare and Medicaid.
• Ensured the majority of commercially insured U.S. patients enrolled in its patient services program faced little to no out of pocket costs:
  • 75% of enrolled ONPATTRO patients and 87% of enrolled GIVLAARI patients have zero cost sharing for the medicine.
• Achieved reimbursed access to ONPATTRO and GIVLAARI an average of 11 months faster than other orphan drugs in major European countries.
• Established availability of ONPATTRO in more than 20 countries through direct reimbursement or expanded access.

Advocating for covered use of home administration: Travel to an infusion center or hospital to receive treatment can be challenging for some patients, especially during the COVID-19 pandemic. To support patients, Alnylam has advocated for insurers to cover home infusion, and today:

• 20% of U.S. commercial patients on ONPATTRO and GIVLAARI are receiving treatment in the home.
• Seven countries in the EU and Canada offer home administration with reimbursement for our medicines.

Executed nearly 30 value-based agreements (VBAs) with U.S. payers (ONPATTRO – 19; GIVLAARI – 10): Alnylam has pro-actively engaged with payers on VBAs to link reimbursement of its medicines with product performance and value delivered. VBAs represent a commitment to work with payers on business innovations that address the needs of patients. The company has also pioneered additional components for its VBA framework, including:

• Prevalence-Based Adjustment (PBA) for its ultra-rare orphan disease products, where the company has committed to lower the price of its medicine if the number of patients identified within a plan population exceeds the expected disease prevalence.
• Patient-Need Adjustment (PNA), where the company provides payers with greater budget certainty for medicines administered across a broad range of patient age groups. The company is applying this innovative PNA component in VBAs for OXLUMO.

“Three years ago, we set out to achieve what mattered to us: getting our RNAi therapeutics to those who can benefit from them and do it in a way that delivers value,” said John Maraganore, PhD, Chief Executive Officer of Alnylam. “As an increasing number of medicines become available to treat people with rare genetic diseases, insurers face challenges paying for them. We’ve engaged in innovative agreements that tie payments to health outcomes, or provide rebates when plans encounter more patients or higher drug usage than expected. Our healthcare system needs more pragmatic approaches such as these to ensure patients obtain access to needed therapies and that real value is delivered for the cost. We are very proud of our progress, and plan to continue to innovate and collaborate to ensure that patients have access to our medicines.”

Alnylam Rare Disease Trend Report

Critical to Alnylam’s strong market access results is a desire to understand the priorities of payers. The company is issuing its first U.S. Rare Disease Trend Report, resulting from interviews with 30 payer and plan decision-makers about barriers to rare disease access over a five-year horizon. The findings reveal increasing concern about the sustainability of expenditures on rare disease medicines and potential strategies that may be implemented to manage costs. As a leader in the advancement of innovative medicines for rare diseases, the company plans to conduct this survey, and issue an updated version of the report, annually.

Key findings:

• Managing rare disease drug utilization. Payers express concern about the increased use and number of rare disease therapies and the associated rising costs. Current focus areas for therapeutic utilization management include central nervous system and respiratory medicines. Future areas of management may include digestive and bleeding disorder therapies.
• Healthcare economic evidence: Payers believe metrics beyond clinical efficacy, such as healthcare economic evidence, must play an increasing role in how we value medicines. However, they note there is currently a dearth of this type of evidence, particularly for emerging therapies.
• Risk-sharing: Approximately 50% of payers engage in innovative payment models for rare disease medicines today, but this is limited largely to oncology. Payers express interest in pursuing more outcomes-based contracts, but they cite operational obstacles such as administrative burden from data collection, data privacy concerns, interoperability of electronic health records and clarity on outcomes to track.

“This is a forward-looking report about how our healthcare system must continue to evolve and consider the mid-and long-term value of rare disease therapies for the benefit of patients, families and communities,” commented Shirley Bachman, Vice President, US Market Access at Alnylam. “Through open dialogue and collaboration with payers, we endeavor to find contracting solutions that mitigate risk and offer greater cost predictability. This helps ensure that payers can plan effectively and have greater confidence in covering our therapies for patients who need them.”

To read more about Alnylam’s global market access progress, download the full Patient Access Philosophy Report here. For those interested in reading more insights from payers on delivering access to rare and ultra-rare disease medicines, the inaugural Rare Disease Trend Report can be found here.

About RNAi

RNAi (RNA interference) is a natural cellular process of gene silencing that represents one of the most promising and rapidly advancing frontiers in biology and drug development today. Its discovery has been heralded as “a major scientific breakthrough that happens once every decade or so,” and was recognized with the award of the 2006 Nobel Prize for Physiology or Medicine. By harnessing the natural biological process of RNAi occurring in our cells, a new class of medicines, known as RNAi therapeutics, is now a reality. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam’s RNAi therapeutic platform, function upstream of today’s medicines by potently silencing messenger RNA (mRNA) – the genetic precursors – that encode for disease-causing or disease pathway proteins, thus preventing them from being made. This is a revolutionary approach with the potential to transform the care of patients with genetic and other diseases.

About Alnylam Pharmaceuticals

Alnylam (Nasdaq: ALNY) is leading the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare genetic, cardio-metabolic, hepatic infectious, and central nervous system (CNS)/ocular diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach for the treatment of a wide range of severe and debilitating diseases. Founded in 2002, Alnylam is delivering on a bold vision to turn scientific possibility into reality, with a robust RNAi therapeutics platform. Alnylam’s commercial RNAi therapeutic products are ONPATTRO® (patisiran), GIVLAARI® (givosiran), and OXLUMO™ (lumasiran). Alnylam has a deep pipeline of investigational medicines, including six product candidates that are in late-stage development. Alnylam is executing on its “Alnylam 2020” strategy of building a multi-product, commercial-stage biopharmaceutical company with a sustainable pipeline of RNAi-based medicines to address the needs of patients who have limited or inadequate treatment options. Alnylam is headquartered in Cambridge, MA. For more information about our people, science and pipeline, please visit www.alnylam.com and engage with us on Twitter at @Alnylam or on LinkedIn.

Alnylam Forward Looking Statements

Various statements in this release concerning Alnylam’s future expectations, plans and prospects, including, without limitation, Alnylam’s views with respect to its progress advancing its stated 2017 Patient Access Philosophy, its efforts to support patients in gaining access to needed medicines, both before and during the COVID-19 pandemic, and initiatives to deliver strong value to payers in the face of increasing barriers to access for rare disease medicines, the Company’s plans to conduct a Rare Disease Trend survey, and issue an updated version of its Rare Disease Trend Report, annually, and expectations regarding the advancement of its “Alnylam 2020” guidance for the advancement and commercialization of RNAi therapeutics, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results and future plans may differ materially from those indicated by these forward-looking statements as a result of various important risks, uncertainties and other factors, including, without limitation: the direct or indirect impact of the COVID-19 global pandemic or any future pandemic, such as the scope and duration of the outbreak, government actions and restrictive measures implemented in response, material delays in diagnoses of rare diseases, initiation or continuation of treatment for diseases addressed by Alnylam products, or in patient enrollment in clinical trials, potential supply chain disruptions, and other potential impacts to Alnylam’s business, the effectiveness or timeliness of steps taken by Alnylam to mitigate the impact of the pandemic, and Alnylam’s ability to execute business continuity plans to address disruptions caused by the COVID-19 or any future pandemic; Alnylam’s ability to discover and develop novel drug candidates and delivery approaches and successfully demonstrate the efficacy and safety of its product candidates; the pre-clinical and clinical results for its product candidates, which may not be replicated or continue to occur in other subjects or in additional studies or otherwise support further development of product candidates for a specified indication or at all; actions or advice of regulatory agencies, which may affect the design, initiation, timing, continuation and/or progress of clinical trials or result in the need for additional pre-clinical and/or clinical testing; delays, interruptions or failures in the manufacture and supply of its product candidates or its other marketed products; obtaining, maintaining and protecting intellectual property; intellectual property matters including potential patent litigation relating to its platform, products or product candidates; obtaining regulatory approval for its product candidates, and maintaining regulatory approval and obtaining pricing and reimbursement for its products, including ONPATTRO, GIVLAARI and OXLUMO; progress in continuing to establish an ex-United States infrastructure; successfully launching, marketing and selling its approved products globally, including ONPATTRO, GIVLAARI and OXLUMO, and achieving net product revenues for ONPATTRO within its revised expected range during 2020; Alnylam’s ability to successfully expand the indication for ONPATTRO in the future; competition from others using technology similar to Alnylam’s and others developing products for similar uses; Alnylam’s ability to manage its growth and operating expenses within the ranges of guidance provided by Alnylam through the implementation of further discipline in operations to moderate spend and its ability to achieve a self-sustainable financial profile in the future without the need for future equity financing; Alnylam’s ability to establish and maintain strategic business alliances and new business initiatives; Alnylam’s dependence on third parties, including Regeneron, for development, manufacture and distribution of certain products, including eye and CNS products, and Vir for the development of ALN-COV and other potential RNAi therapeutics targeting SARS-CoV-2 and host factors for SARS-CoV-2; the outcome of litigation; the risk of government investigations; and unexpected expenditures; as well as those risks more fully discussed in the “Risk Factors” filed with Alnylam’s most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings that Alnylam makes with the SEC. In addition, any forward-looking statements represent Alnylam’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Alnylam explicitly disclaims any obligation, except to the extent required by law, to update any forward-looking statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201207005267/en/

Alnylam Pharmaceuticals, Inc.

Christine Regan Lindenboom

(Investors and Media)

617-682-4340

Josh Brodsky

(Investors)

617-551-8276

KEYWORDS: Massachusetts United States North America

INDUSTRY KEYWORDS: Health Infectious Diseases Genetics Clinical Trials Pharmaceutical Biotechnology

MEDIA:

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AstroNova Reports Third-Quarter Fiscal 2021 Financial Results

• Bookings of $27.9 million
• Backlog of $23.2 million
• Revenue of $28.0 million
• Operating income of $0.4 million
• Net income of $0.0 million, or $0.00 per diluted share
• EBITDA of $1.7 million, or 6.1% of revenue

WEST WARWICK, R.I.–(BUSINESS WIRE)–
AstroNova, Inc. (NASDAQ: ALOT), a global leader in data visualization technologies, today announced financial results for the fiscal 2021 third quarter ended October 31, 2020.

“Our Product Identification segment delivered both revenue and margin improvements in the quarter while Test & Measurement continued to reflect the effects of the Boeing 737 MAX grounding and COVID-19 on the commercial aerospace industry,” said Greg Woods, AstroNova’s President and Chief Executive Officer. “Overall performance was aided by continuous improvement initiatives and reduced operating expenses. During the quarter we continued to invest in new products and technologies to support growth across our businesses.

“In Product Identification, strong demand from our TrojanLabel^®, QuickLabel^® and GetLabels^® product lines drove year-on-year and sequential growth in both revenue and operating profit,” Woods said. “Our product and technology innovations are attracting a broader base of customers to our color label and specialty printing systems. We are helping businesses across a wide spectrum of industries enhance efficiency, eliminate waste and increase brand recognition.

“In our Test & Measurement segment, growth in our defense business partly offset weakness in commercial aerospace caused by the external headwinds. Looking ahead, recent progress on the potential approval of multiple coronavirus vaccines, and the FAA’s November decision that cleared the 737 MAX for a return to service, bode well for the T&M segment as we move through fiscal 2022 and beyond,” Woods concluded.

Q3 FY 2021 Operating Segment Results

Product Identification segment revenue was $22.9 million, compared with $21.7 million in the prior-year period. Segment operating income was $3.5 million, or 15.4% of revenue, compared with $1.9 million, or 8.6% of revenue, in the prior year, reflecting both increased efficiencies and reductions in operating costs.

Test & Measurement segment revenue was $5.1 million, compared with $11.6 million in the same period of fiscal 2020, due to the continued grounding of the Boeing 737 MAX and rapid demand falloff in the aerospace industry related to COVID-19. The Test & Measurement segment recorded an operating loss of $0.8 million, or negative 14.7% of revenue, compared with segment operating income of $1.4 million, or 12.1% of revenue, in the comparable period of fiscal 2020, a direct result of declines in aerospace printer sales and adverse mix, despite lower manufacturing and operating costs.

Hardware revenue dropped to $7.7 million, compared with $12.2 million in the prior-year period due to Test & Measurement weakness. Supplies revenue was $18.0 million versus $17.7 million in the same period of fiscal 2020. Service/other revenue was $2.4 million, compared with $3.5 million a year earlier.

Q3 FY 2021 Results Summary

Revenue totaled $28.0 million, compared with $33.3 million in the year-earlier period, with a decline in Test & Measurement revenue partly offset by higher revenue in the Product Identification segment.

Gross profit was $9.7 million, or 34.7% of revenue, compared with $12.3 million, or 36.9% of revenue, in the same period of fiscal 2020. The decrease reflected lower revenue and less favorable product mix in the 2021 period, primarily in the Test & Measurement segment.

Operating expenses totaled $9.3 million, down 21.4% compared with $11.9 million in the third quarter of fiscal 2020, reflecting the Company’s cost-reduction actions.

Operating income was $0.4 million in the third quarters of fiscal 2021 and 2020.

Other expense included foreign exchange losses resulting from the weaker Euro and Danish Kroner on exposures in those currencies and higher interest expense.

Net income was $12,000, or $0.00 per share, compared with net income of $0.5 million, or $0.06 per diluted share, for the third quarter of fiscal 2020.

Earnings before interest, taxes, depreciation, and amortization (EBITDA) were $1.7 million, compared with $2.0 million in the third quarter of fiscal 2020. EBITDA is a non-GAAP financial measure explained in greater detail below under “Use of Non-GAAP Financial Measure.” Please refer to the financial reconciliation table included in this news release for a reconciliation of EBITDA to net income for the fiscal third quarters ended October 31, 2020 and November 2, 2019.

Bookings were $27.9 million, compared with $32.6 million in the third quarter of fiscal 2020.

Backlog at October 31, 2020 was $23.2 million versus $20.8 million at the end of the fiscal 2020 third quarter.

Recent Highlights

• AstroNova launched a range of new products that expanded its addressable market beyond label printing at the PACK EXPO Connects 2020 international packaging tradeshow. These products included the TrojanLabel T2-C Print and Apply Solution that eliminates intermediate steps in the typical labeling process. Also demonstrated were in-line barcode verification systems and label finishing systems.
• AstroNova received an exclusive, multi-year commitment from a major North American air carrier to purchase the Company’s ToughWriter brand of narrow-format flight deck printers for the carrier’s Boeing 737 aircraft.

Q3 FY 2021 Conference Call

AstroNova will discuss its third-quarter fiscal 2021 financial results in an investor conference call at 9:00 a.m. ET today. To participate on the conference call, please dial (800) 367-2403 (U.S. and Canada) or (334) 777-6978 (International) approximately 10 minutes prior to the start time and enter confirmation code 2309769.

You can hear a replay of the conference call from 12:00 p.m. ET Monday, December 7, 2020 until 12:00 p.m. ET on Monday, December 14, 2020 by dialing (888) 203-1112 (U.S. and Canada) or (719) 457-0820 (International). The passcode is 2309769. A real-time and an archived audio webcast of the call will be available through the “Investors” section of the AstroNova website, https://investors.astronovainc.com.

Use of Non-GAAP Financial Measure

In addition to financial measures prepared in accordance with generally accepted accounting principles (GAAP), this news release contains the non-GAAP financial measure earnings before interest, taxes, depreciation, and amortization (EBITDA). AstroNova believes that the inclusion of this non-GAAP financial measure helps investors gain a meaningful understanding of changes in the Company’s core operating results, and also can help investors who wish to make comparisons between AstroNova and other companies on both a GAAP and a non-GAAP basis. AstroNova’s management uses EBITDA, in addition to GAAP financial measures, as the basis for measuring its core operating performance and comparing such performance to that of prior periods and to the performance of its competitors. EBITDA also is used by the Company’s management to assist with their financial and operating decision-making.

About AstroNova

AstroNova, Inc. (NASDAQ: ALOT), a global leader in data visualization technologies since 1969, designs, manufactures, distributes, and services a broad range of products that acquire, store, analyze, and present data in multiple formats. The Product Identification segment offers a complete line-up of labeling hardware and supplies, allowing customers to mark, track, and enhance their products’ appearance. The segment is comprised of three business units: QuickLabel®, the industry leader in tabletop digital color label printing; TrojanLabel®, an innovative leader for professional label presses; and GetLabels™, the premier supplier of label materials, inks, toners, ribbons, and adhesives, all compatible with the major printer brands. Supported by AstroNova’s customer application experts and technology leadership in printing, material science, and high-speed data processing, customers benefit from an optimized, “total solution” approach. The Test and Measurement segment includes the AstroNova Aerospace business unit, which designs and manufactures flight deck printers, networking hardware, and related accessories serving the world’s aerospace and defense industries with proven advanced airborne technology solutions for the cockpit and the cabin; and the Test and Measurement business unit, which offers a suite of products and services that acquire, record, and analyze electronic signal data from local and networked sensors. AstroNova is a member of the Russell Microcap® Index and the LD Micro Index (INDEXNYSEGIS: LDMICRO). Additional information is available by visiting www.astronovainc.com.

Forward-Looking Statements

Information included in this news release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact but rather reflect our current expectations concerning future events and results. These statements may include the use of the words “believes,” “expects,” “intends,” “plans,” “anticipates,” “likely,” “continues,” “may,” “will,” and similar expressions to identify forward-looking statements. Such forward-looking statements, including those concerning the Company’s anticipated performance, clearance of the 737 MAX to return to service, and the potential approval of a coronavirus vaccine, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in the Company’s Annual Report on Form 10-K for the fiscal year ended January 31, 2020 and subsequent filings AstroNova makes with the Securities and Exchange Commission. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. The reader is cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this news release.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201207005207/en/

Scott Solomon

Senior Vice President

Sharon Merrill Associates

(617) 542-5300

[email protected]

KEYWORDS: Rhode Island United States North America

INDUSTRY KEYWORDS: Technology Packaging Hardware Manufacturing

MEDIA:

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Join IntelliChief, an Infor Solution Partner, on December 8th from 2-4 pm EST for a presentation, live demo, and customer Q&A covering IntelliChief’s seamless integration with Infor XA, enhancements in operational efficiency in AP, and ROI potential.

Zachary Leete
IntelliChief
2394049545
[email protected]