InterMune, Inc. Buy Target $ 13

Nov 30

InterMune, Inc.

ITMN : NASDAQ : US$9.36
BUY  Target: US$13.00 

COMPANY DESCRIPTION:
InterMune is a development stage biopharmaceutical company focused on the development of drugs that address unmet medical needs in hepatology and pulmonology. The company is developing pirfenidone for the treatment of idiopathic pulmonary fibrosis (IPF).

Investment recommendation
Reiterate BUY, $13 target on improved EU Esbriet (pirfenidone) launch momentum. We think Esbriet, ITMN’s drug for idiopathic pulmonary
fibrosis (IPF; an orphan lung disease), has good peak EU potential. Esbriet launch has encountered marketing challenges, but appears to now be
trending positive. Still, we see headwinds from potential competitor data in late 2013. Our worldwide peak sales estimate is ~$2B in 2025, and our
target is based on a DCF and pNPV analysis.
Investment highlights
 As expected, Esbriet gets an initial negative recommendation from NICE in appraisal first draft; we think price flexibility could lead to positive recommendation later in 2013. ITMN hinted in its Q3 call that it might receive a negative first round appraisal.

We think ITMN will exercise flexibility on price, allowing eventual launch in the UK. Based on conversations with UK IPF experts, we think the final UK price may be substantially lower than the $42K/year ITMN submitted to NICE, possibly as low as around $30K/year. Nevertheless, we expect
good UK uptake to be positive on UK IPF expert support.
 ITMN expects final NICE appraisal in March 2013; we think NICE could stretch process in H2/13. After this recommendation, a ~1 month
consult period begins for comments on the first appraisal. After this, the committee may meet again, after which final guidance is published.
Given the consultation period falls during holiday season, ITMN cautioned review could stretch into Jan., with a meeting in late Jan. 2013 and final guidance in March. We see Esbriet as just the sort of drug NICE tortuously appraises, and expect a decision in H2/13.

Intermune Inc. Blockbuster Potential Target $25.00

Micrograph of usual interstitial pneumonia (UI...

Micrograph of usual interstitial pneumonia (UIP). UIP most often represents idiopathic pulmonary fibrosis. H&E stain. Autopsy specimen. (Photo credit: Wikipedia)

InterMune, Inc.

April 9

ITMN : NASDAQ : US$15.28  Buy , Target US$25.00

Esbriet French grade supports continued strong EU pricing; delay to ASCEND may put Esbriet in dead heat with BI’S 112O for US

Recommendation

BUY, $25 target on Esbriet (pirfenidone) positive GBA assessment,potential for blockbuster worldwide sales, US clinical success.

Esbriet is ITMN’s drug for idiopathic pulmonary fibrosis (IPF), an orphan lung disease. 

Major Esbriet EU commercial potential (despite price concerns), encouraging 2012 adoption, and worldwide peak sales of ~$4B. Our $24 target is based on a sum-of -the- parts analysis

Highlights 

French grades supportive of final premium ~$40K price, expected early Q4/12.

The French Transparency Commission conferred an ASMR grade 4 and SMR “low” rating, which should allow full reimbursement under the “ALD” chronic disease exception. The decision notes no other drug is effective in IPF.

The final price will be published in the Journal Officiel ~45 days after determination. 

CEPS admin delays likely to have minimal impact on final price, in our view.France has a favorable track record for orphan pricing. We believe the final CEPS price is likely to come after the final German AMNOG price (due by Sept 15), and will thus take German pricing into account as other EU net drug prices, are key inputs. 

. We continue to see little impact on ultimate  

drug pricing in Italy and Spain, although we note Spain macro pressures are growing. 

ASCEND six-mo. delay may put pirfenidone in dead heat with BI Phase 3 BIBF- 1120. Phase 3 data from both programs is due Q4/13.

 

 

Follow

Get every new post delivered to your Inbox.

Join 1,180 other followers