Innoviva
Overview
Innoviva, Inc., (INVA) formerly Theravance, Inc., is engaged in the development, commercialization and financial management of bio-pharmaceuticals. It focuses on the respiratory assets partnered with Glaxo Group Limited (GSK), including RELVAR/BREO ELLIPTA (fluticasone furoate (FF)/vilanterol (VI)) and ANORO ELLIPTA (umeclidinium bromide/vilanterol (UMEC/VI)). Under the Long-Acting Beta2 Agonist (LABA) Collaboration Agreement and the Strategic Alliance Agreement with GSK, the Company is eligible to receive the annual royalties from GSK on sales of RELVAR/BREO ELLIPTA. For other products combined with a LABA from the LABA collaboration, such as ANORO ELLIPTA, royalties are upward tiering and range from 6.5% to 10%. RELVAR/BREO is a once-a-day combination inhaled respiratory medicine consisting of a LABA (VI) and an inhaled corticosteroid (ICS), FF. ANORO ELLIPTA a once-daily medicine combining a long-acting muscarinic antagonist (LAMA), umeclidinium bromide (UMEC), with a LABA.
The Company was incorporated in Delaware in November 1996 under the name Advanced Medicine, Inc., and began operations in May 1997. It later changed its name to Theravance, Inc. in April 2002. In June 2014, the company spun-off its research and development operations. In January 2016, the company rebranded and changed its name to Innoviva, Inc.
Patents and Proprietary Rights
The company and its collaborative partner will be able to protect its partnered technology from unauthorized use by third parties only to the extent that such technology is covered by valid and enforceable patents or is effectively maintained as trade secrets. The company's success in the future will depend in part on it and its collaborative partner obtaining patent protection for its partnered products and product candidates. Accordingly, patents and other proprietary rights are essential elements of its business.1
For proprietary know-how that is not patentable, processes for which patents are difficult to enforce and any other elements of its business that involve proprietary know-how and technology that is not covered by patent applications, the company rely on trade secret protection and confidentiality agreements to protect its interests. The company require all of its employees, consultants and advisors to enter into confidentiality agreements. Where it is necessary to share its proprietary information or data with outside parties, its policy is to make available only that information and data required to accomplish the desired purpose and only pursuant to a duty of confidentiality on the part of those parties.
As of December 31, 2019, the company owned 39 issued United States patents and 298 granted foreign patents, as well as additional pending United States patent applications and foreign patent applications. The claims in these various patents and patent applications are directed to compositions of matter, including claims covering product candidates, lead compounds and key intermediates, pharmaceutical compositions, methods of use and processes for making its compounds.
United States issued patents and foreign patents generally expire 20 years after filing. Nevertheless, issued patents can be challenged, narrowed, invalidated or circumvented, which could limit its ability to stop competitors from marketing similar products and threaten its ability to commercialize its product candidates. The company's patent position, similar to other companies in its industry, is generally uncertain and involves complex legal and factual questions. To maintain its proprietary position, the company will need to obtain effective claims and enforce these claims once granted. It is possible that, before any of its products can be commercialized, any related patent may expire or remain in force only for a short period following commercialization, thereby reducing any advantage of the patent. Also, the company do not know whether any of its patent applications will result in any issued patents or, if issued, whether the scope of the issued claims will be sufficient to protect its proprietary position.
Financial Highlights
In the year ended December 31, 2019, the net income attributable to Innoviva stockholders was $157.3 million, a decrease of $237.8 million from net income of $395.1 million in the year ended December 31, 2018, primarily due to the $196.1 million income tax benefit recognized in the year ended December 31, 2018 as compared to the $41.9 million of income tax expense recognized in the year ended December 31, 2019 as further described below. Cash, cash equivalents, and marketable securities totaled $350.8 million as of December 31, 2019, an increase of $235.9 million from December 31, 2018. The increase was primarily due to cash provided by operating activities of $257.5 million.
Recent development
Feb. 27, 2020-- GlaxoSmithKline plc (GSK) and Innoviva, Inc. (INVA) today announced the acceptance of a regulatory submission seeking an additional indication for the use of once-daily, single-inhaler triple therapy, Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol or FF/UMEC/VI) for the treatment of asthma in adults by the European Medicines Agency (EMA).2
The submission is supported by the pivotal Phase III clinical study (CAPTAIN), conducted in 2,436 adult asthma patients across 15 countries whose disease remained inadequately controlled despite treatment with a combination of an inhaled corticosteroid and a long-acting β2-agonist (ICS/LABA). The study met its primary endpoint, demonstrating a statistically significant improvement in lung function compared with the ICS/LABA, Relvar/Breo Ellipta.
