Regulatory compliance will be the number one focus for Sun Pharma, the company says, following its $3.2bn (€2.3bn) takeover of Indian generics firm Ranbaxy.
Sun Pharma made the comments during a conference call this morning in response to questions about the wisdom of buying Ranbaxy from Japanese drugmaker, Daiichi Sankyo.
Investors asked about the pricetag in light of the US import ban on drugs and active pharmaceutical ingredients (API) made at Ranbaxy's plants in Toansa , Paonta Sahib, Dewas and Mohali in India.
Others raised the consent decree the firm has been operating under since 2012 as a concern.
Managing Director Dilip Shanghvi agreed that Ranbaxy had “faced manufacturing challenges,” contributing to the net loss over the past three years , but said Sun Pharma believed “the valuation is justified” based on the firm's underlying business in India and emerging markets.
Company spokesperson Uday Baldota told in-Pharmatechnologist.com that whilst it was "difficult to give specifics at this stage," it is "suffice to say that we have resolved a consent decree situation in the past."
Furthermore the company told us the deal would “see tremendous growth opportunities especially in ROW [rest of the world] and India markets,” adding Sun is confident it “can create lasting value for our shareholders through the combined entity.”
Compliance in US market
According to its own report, Sun Pharma’s business is geographically split with 60% of its products destined for the US market, 23% for India and 17% for the ROW. Ranbaxy’s market, meanwhile, is 50% of ROW, 21% India and 29% US-focused. Following the merger the company anticipates US sales of over $2bn, representing 47% of its revenue.
For this to happen, the company has acknowledged the US regulatory issues. “Our focus will be to address the issue of achieving compliance,” Shanghvi said, adding that a predicted $250m of revenue and operational synergies by 3rd year would not come from the manufacturing side.
“Energy has to be focused on achieving compliance,” he added. “At this point I’d prefer not to give specific timelines about compliance, all I can promise is it will be the most important focus for the management to follow.”
‘Better to go out now’
Ranbaxy owner Daiichi Sankyo did not respond to attempts by this publication for further comment regarding the sale. However former Ranbaxy Executive Director Ramesh Adige told New Delhi Television Daiichi “must have thought that they can't settle the problems of this company and its better to go out now.”
“This is the right time for Sun Pharma to buy Ranbaxy,” he continued. “Ranbaxy's problem with from the US Food and Drug Administration (FDA) cannot get more intense than they are already, things can only improve from now onwards.”
However, for now the bad news continues to come for Ranbaxy with the firm announcing the US Attorney's Office for the District of New Jersey has issued an administrative subpoena dated March 13, seeking information regarding the Toansa facility and the inspection that led to January’s import alert.
Sun Chairman Israel Makov told stakeholders this morning “Daiichi Sankyo has agreed to indemnify Sun Pharma and Ranbaxy for, among other things, certain costs and expenses that may arise” from the subpoena, as part of the transaction.