May 18, 2014, 10:53 PM
- Intermune (ITMN) reports results from its Ascend Phase 3 clinical trial evaluating pirfenidone in patients with idiopathic pulmonary fibrosis (IPF). It achieved its primary endpoint of significantly reducing the decline in lung function as measured by percent forced vital capacity (FVC) from baseline to week 52. The magnitude of the treatment effect was measured by comparing the proportion of patients in the pirfenidone and placebo groups experiencing either a 10% decline in FVC or death. A 10% decline is strongly predictive of a higher risk of mortality. At week 52, 16.5% of the pirfenidone group experienced a 10% or more decline in FVC or death compared to 31.8% in the placebo group. This represents a 47.9% reduction in the proportion of patients who experienced this clinical threshold or death. Also, 22.7% of the pirfenidone patients experienced no decline in FVC compared to 9.7% in the placebo group.
- Statistically significant results were also shown in two secondary endpoints of change on six-minute walk distance and progression-free survival as measured by baseline vs week 52. Another secondary endpoint, dyspnea (shortness of breath) was not met.
May 1, 2014, 5:53 PM
- Esbriet product sales: $30.3M (+188.6%).
- Loss from operations: $49.5M (-3.8%).
- Net loss: $53.6M (-7.4%).
- Quick assets (ex-A/R) at quarter end: $606.4M (+56.7%).
- Updated 2014 guidance:
- Esbriet revenue: $130M- 140M, up from $115M - $135M.
- R&D expense: $110M - $120M (unch).
- SG&A expense: $210M - $225M (unch).
- (ITMN +0.2%)
May 1, 2014, 4:22 PM
Apr. 30, 2014, 5:35 PM
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Apr. 29, 2014, 8:00 AM
- Intermune (ITMN) is the latest pharmaceutical company to be linked with merger news, with the Betaville blog reporting that the firm is the subject of takeover interest from Actelion (ALIOF) and Sanofi (SNY).
- Actelion has apparently lined up $3-4B in financing from several banks, including JPMorgan.
- Intermune shares are +1.8% premarket; its market cap is $3.02B as of yesterday's close.
Mar. 21, 2014, 11:44 AM
- Shares of Intermune (ITMN +10.2%) rise after the disclosure of mixed late-stage trial results for Boehringer Ingelheim's rival drug.
- The company's pirfenidone and BI's nintedanib both treat ideopathic pulmonary fibrosis.
- Data from two trials showed nintedanib improved lung function, but one trial failed to meet its secondary goals of improving overall health and delaying flare-ups of the disease.
- Intermune recently completed a phase 3 that showed a significant reduction in disease progression versus placebo.
Mar. 21, 2014, 9:15 AM
Mar. 14, 2014, 10:04 AM
- InterMune (ITMN) prices its offering of 7.5M shares of common stock at $32.75/share netting $233M to the company.
- Overallotment is 1.125M shares.
- Proceeds will be used to fund Esbriet commercialization.
Mar. 12, 2014, 5:40 PM
Mar. 12, 2014, 4:27 PM
- InterMune (ITMN) to offer 7.5M shares of common stock for public sale plus an optional 1.125M shares for underwriters.
- The company will use the net proceeds to fund Esbriet (pirfenidone) commercialization activities including the product's eventual launch in the US, R&D projects and for general corporate purposes.
Mar. 11, 2014, 8:30 AM
- Goldman Sachs upgrades InterMune (ITMN) to Buy with a price target of $45 citing better-than-expected top line Phase 3 results for pirfenidone.
- Analyst Terence Flynn models peak sales of $1.3B based on a projected price of $75,000.
- Q3 FDA filing date may be conservative.
- 11 of 14 analysts rate the company at least Buy.
- Consensus revenue estimates for 2014 and 2015 are $137M and $316M, respectively.
Mar. 7, 2014, 12:45 PM
Mar. 7, 2014, 12:14 PM
- Market buzz remains high about several pharmaceutical companies' interest in the orphan drug maker.
- InterMune (ITMN) considered selling itself three years ago but no deals were reached due to uncertainty with pirfenidone data.
- On February 25, the company disclosed positive trial data showing significant slowing of disease progression versus placebo. Shares gapped up 170% on a 17-fold increase in volume.
- Shares are up 14% on heavy volume in today's trading.
- 250 mutual funds have positions.
Feb. 26, 2014, 3:34 PM
- Maintaining a Neutral rating while raising the price target to $40, Goldman's Terence Flynn says yesterday's trial results should support U.S. approval in Q2 of 2015. He's raising the probability of approval to 100% from 30% and raising his estimate of peak market share to 50% from 30%, but not changing pricing or compliance assumptions. "We expect complete data to be presented at the ATS conference in May, where we also hope to gain insight on the competitive landscape with the potential presentation of Ph3 data from Boehringer Ingelheim's BIBF-1120."
- Not convinced sales will be as large as the market is currently pricing in, Jefferies' Eun Yang maintains his Underperform rating while lifting the price target to $20. "Our new $20 PT is based on U.S./EU peak sales estimates of $650M/$300M, not a conservative assumption in our view."
- Its work here done, Leerink Swan removes its Buy rating on the stock.
- ITMN is giving back just a bit of yesterday's moonshot, -12.7% to $32.99.
Feb. 25, 2014, 2:14 PM
- InterMune's (ITMN +162.8%) spectacular gains after reporting positive ASCEND data (I, II) may have further to go, Baird analyst Brian Skorney believes, viewing ITMN as an ideal acquisition target for a big pharma company.
- A substantial unmet need in idiopathic pulmonary fibrosis provides a blockbuster market opportunity, Baird says, with a number of companies with the capability to sell ITMN's drug with their current salesforce, most notably GlaxoSmithKline (GSK), Gilead (GILD) and Novartis (NVS); Skorney sees a potential acquisition price into the 60s.
- Even without an acquisition, Skorney thinks ITMN should reach $44, with clinical risk is now in the rear-view mirror and potential for greater penetration and higher pricing in the U.S.
Feb. 25, 2014, 12:46 PM
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