Pharmaceutical News: Takeda says has not agreed to buy Nycomed

Takeda says has not agreed to buy Nycomed

Takeda, Japan’s largest drugmaker, said on Friday it has not agreed to buy Swiss rival Nycomed, following reports it was in talks to buy the privately held company for more than $12 billion.

Such a deal would boost Takeda’s global reach into Europe and emerging markets.

“The company would like to make clear that Takeda has not agreed to any such an agreement as suggested by certain newspaper publications,” the group said in a statement on its website.

“Takeda is constantly seeking and evaluating opportunities to increase shareholder value and enhance our business through strategic investment; however, there is nothing that needs to be announced at this point,” Takeda said.

A person familiar with the matter told Reuters that a deal, which would be Japan’s second-biggest overseas takeover, was in its final stages but might take time to conclude.

Teva Generic Sales Remain Weak

Teva Pharmaceutical Industries’ (TEVA – Analyst Report) first quarter earnings of $1.04 per American Depository Share (ADS) were in-line with the Zacks Consensus Estimate. Earnings, however, increased 14.3% from the year-ago period.

While first quarter revenues increased 11.7% to $4.1 billion, revenues fell short of the Zacks Consensus Estimate of $4.3 billion. The company reported sales growth in Europe (66%) and EEMA, Latin America and Asia (26%). However, North America disappointed with sales declining 11%.

The Quarter in Detail

US generic sales remained weak in the first quarter. Sales in North America declined 11% to $2,064 million with US generic and other sales declining 32% to $952 million. The lack of major launches in the first quarter of 2011 affected performance.

Moreover, the voluntary suspension of production at the Irvine plant and the slowdown in the Jerusalem facility due to the receipt of a warning letter from the US Food and Drug Administration (FDA) affected generic revenues. Both these factors impacted revenues by $100 million.

Teva resumed partial production at the Irvine plant in April 2011 with full production expected to resume by year end. The company also submitted a response to the warning letter for the Jerusalem facility and has requested the FDA to re-inspect the facility.

We expect the US generics business to bounce back in the second half of 2011. Teva has about 40 potential launches lined up for 2011. Important product launches include generic versions of Zyprexa, Levaquin, Aricept and Nasacort. Approval of generic Lovenox would be a major boost for the stock.

Key branded product, Copaxone, posted global in-market sales of $907 million, up 14%. While US in-market sales increased 22% to $624 million, ex-US in-market sales remained flat at $283 million. Sales were driven by price increases and unit growth in certain markets which were partially offset by price cuts in Germany and other markets. The company reported that Copaxone’s global market share increased to 31%. Teva took a price increase for Copaxone in January 2011.

Other products/segments that contributed to growth were Azilect at $90 million, up 16%, and the women’s health business which recorded 30% growth with sales coming in at $103 million. The inclusion of sales of Theramex products helped drive growth in the women’s health business.

We were pleased to see a 19% increase in sales from the global respiratory business. Sales came in at $229 million with growth being driven by strong sales in Europe, especially for Qvar.

Teva is working on strengthening its position in the respiratory market and expects to file for approval of four new products in 2011, including a May 2011 filing for Qnaze for the treatment of perennial allergic rhinitis.

Pharmaceutical revenues in Europe increased 66% to $1,344 million, mainly due to strong generic sales in Italy, Spain, Germany, and France. Results benefited from the inclusion of ratiopharm’s business. Teva’s acquisition of ratiopharm should help the company strengthen its position in key European markets, especially in Germany. European sales should continue improving in the coming quarters.

International (EEMA, Latin America and Asia) pharmaceutical revenues grew 26% during the quarter with sales coming in at $672 million. Increased sales in Russia and Latin America helped boost revenues.

API sales increased 32% to $184 million. Currency fluctuations boosted total revenues by $27 million.

Research & Development expense increased 15% to $239 million. Meanwhile, Selling and Marketing (S&M) expenditures (excluding amortization of purchased intangible assets) increased 10.9% to $825 million. General and Administrative expenditures also increased from the year-ago quarter to $221 million, up 21.4%.

Maintains 2011 Guidance

Teva maintained its guidance for 2011. The company expects earnings in the range of $4.90 to $5.20 on revenues of $18.5 billion to $19 billion. Performance is expected to be stronger during the second half of the year. The guidance does not include the impact of any acquisitions in 2011. The Zacks Consensus Estimate currently points at earnings of $5.08 on revenues of $18.7 billion.

Earlier this month, Teva announced its intention to acquire Cephalon, Inc. (CEPH – Analyst Report) for $6.8 billion The Cephalon deal is in-line with Teva’s long-term strategy of expanding and strengthening its branded and specialty pharma business. Once the acquisition goes through, the combined company’s branded product portfolio will consist of more than 20 products representing sales of about $7 billion.

P&G Deal to Make Teva Leader in Consumer Health Care

During the first quarter of 2011, Teva entered into a partnership agreement with Procter & Gamble (PG – Analyst Report) that will target the consumer health care market. The partnership will bring together both companies’ existing over-the-counter (OTC) medicines and complementary capabilities.

While P&G will bring its strong brand-building, consumer-led innovation and go-to-market capabilities to the partnership, Teva’s broad geographic reach, R&D experience, and extensive product portfolio will be used to drive growth. With this deal, Teva is looking to become a leader in the consumer health care market.

Sagent Pharmaceuticals Reports First Quarter 2011 Financial Results

Sagent Pharmaceuticals, Inc. (Nasdaq:SGNT) today announced financial results for the first quarter ended March 31, 2011 and provided a corporate update.

“The company has already made tremendous progress so far in 2011 as we grew our revenues by more than 250 percent year-over-year and completed our initial public offering in April, pricing at the high end of the range, increasing the number of primary shares offered by 15%, and had our underwriters exercise their overallotment option for an additional 15% of the offering,” said Jeffrey M. Yordon, chief executive officer, founder, and chairman of the board of Sagent. “We expect the funds used from our recently completed initial public offering to be used to support the forthcoming launches of the 45 products represented by the 79 ANDAs that have been recently approved or are pending approval by the FDA, to more rapidly expand our development pipeline and for general corporate purposes.”

Recent Accomplishments
Priced its initial public offering on April 19, 2011 and began trading on the NASDAQ Global Market under the trading symbol “SGNT” on April 20, 2011. Net proceeds from Sagent’s initial public offering were approximately $95.5 million.
Announced U.S. Food and Drug Administration (“FDA”) approval and the launch of four presentations of midazolam injection, USP, a general anesthetic. Midazolam is offered in latex-free vials.

First Quarter 2011 Financial Results

Net revenue for the first quarter of 2011 was $30.3 million, an increase of $21.7 million, or 251%, compared to $8.6 million in the first quarter of 2010. The launch of 31 new codes or presentations of 11 new products since March 2010 contributed $14.2 million, or 65%, of the net revenue increase for the first quarter. Gross profit for the first quarter of 2011 was $4.6 million, or 15.1% of net revenues, compared to $0.3 million, or 3.4% of net revenues, in the first quarter of 2010.

Total operating expenses for the first quarter of 2011 were $8.0 million, compared with $7.4 million for the same period in 2010. Product development expense for the first quarter totaled $2.4 million compared to $2.8 million in the first quarter 2010. Selling, general and administrative (“SG&A”) expenses for the first quarter 2011 totaled $5.0 million compared to $4.2 million in the first quarter 2010, the increase due primarily to increases in headcount and corporate infrastructure to support Sagent’s initial public offering and revenue growth. SG&A comprised 16.4% and 48.2% of net revenue in the first quarter of 2011 and 2010, respectively. The decrease in SG&A as a percentage of revenue reflects the benefit of anticipated sales growth over Sagent’s relatively fixed and in-place selling and administrative infrastructure.

Cash and cash equivalents at March 31, 2011 totaled $32.6 million, and working capital totaled $40.9 million. This does not include the net proceeds of approximately $95.5 million generated from our initial public offering that was completed in April 2011.

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