AstraZeneca PLC

Pharmaceuticals
2
LN: AZN
UK
AstraZeneca

[email protected]

According to its Annual Report filed with the SEC for fiscal year 2019: "AstraZeneca is a global, innovation-driven biopharmaceutical business with operations in over 100 countries and its innovative medicines are used by millions of patients worldwide. AstraZeneca has a legal entity based in Iran, AstraZeneca Pars Company (“AstraZeneca Pars”), which has no employees, and is owned by non-U.S. Group companies. In July 2017, AstraZeneca Pars submitted regulatory applications to the Iranian Food and Drug Administration and subsequently received marketing authorizations for several products. AstraZeneca Pars has not entered into any commercial transaction since its incorporation; products registered under AstraZeneca Pars are exclusively sold by a third-party distributor.

AstraZeneca, through one of its non-U.S. Group companies that is neither a U.S. person nor a foreign subsidiary of a U.S. person, currently has sales of prescription pharmaceuticals in Iran solely through a single third-party distributor, which uses three known entities in the Iranian distribution chain. At this time, none of AstraZeneca’s U.S. entities are involved in any business activities in Iran, or with the Iranian government. To the best knowledge of the management of AstraZeneca, the third-party distributor used by AstraZeneca is not owned or controlled by the Iranian government and AstraZeneca does not have any agreements, commercial arrangements, or other contracts with the Iranian government. However, AstraZeneca understands that one of the independent sub-distributors of AstraZeneca’s third-party distributor is likely to be indirectly controlled by the Iranian government. Further, AstraZeneca’s third-party distributor may initiate payments using banks associated with the government of Iran for the purchase of AstraZeneca products. Finally, Government agencies, hospitals and institutions may purchase AstraZeneca products from the third party distributor or the sub-distributors.

On February 11, 2017, a non-U.S. Group company that is neither a U.S. person nor a foreign subsidiary of a U.S. person entered into a memorandum of understanding with the Iranian Ministry of Health, whereby AstraZeneca committed to improving the overall quality of healthcare and ensuring that Iranian patients have access to the latest innovative and cost-effective medicines. The memorandum of understanding is still in effect. During 2017, 2018, AstraZeneca, through a distributor, conducted health care provider education programs in Iran, including for employees of hospitals owned or controlled by the Iranian Ministry of Health. In this context, AstraZeneca may make additional products available in Iran in the future; where required, relevant U.S. licenses will be sought.

For the year ended December 31, 2019, the Company’s gross revenues and net profits attributable to the above-mentioned Iranian activities were $16.9 million and $5.2 million respectively. For the same period, AstraZeneca’s gross revenues and net profits were $24.4 billion and $1.2 billion, respectively. Accordingly, the gross revenues and net profits attributable to the above-mentioned Iranian activities amounted to approximately 0.069% of AstraZeneca’s gross revenues and approximately 0.43% of its net profits.

At the time of publication, the management of AstraZeneca does not anticipate any change in its activities in Iran that would result in a material impact on AstraZeneca."

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AZ Iran will add to this footprint following the signing of a comprehensive “Memorandum of Understanding” (MoU) with the Iranian Food and Drug Authority. This MoU includes several strategic projects that will further accelerate access to innovative medicines for Iranian patients, and will strengthen local research and advance scientific collaboration.

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AstraZeneca PLC has a U.S. website

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"While Western powers have identified a small group of sectors for Iranian sanction relief, a much wider set of European and U.S. companies—from pharmaceutical firms and medical-equipment makers to food companies and traders—also stands to regain lost Iranian trade as soon as relief measures are formally adopted next month. Western governments singled out Iran's automotive and aviation sectors for temporary sanction relief, while allowing petrochemical exports and trade in gold and other precious metals. But the fine print of the deal also clears the way for GlaxoSmithKline PLC and Sanofi SA, for example, to restart selling many of the drugs they had been forced to cut back on because of increasingly stiff financial sanctions…Pharmaceutical companies Glaxo and AstraZeneca PLC of the U.K. and Sanofi of France reported annual Iranian sales of roughly $32.2 million, $14 million and $13.9 million, respectively, according to their annual SEC reports…A spokeswoman for AstraZeneca said it works in Iran in 'full compliance with the laws and regulations.'" (Wall Street Journal, "Iran Deal Opens Door for Businesses," 12/1/13)