5/4/2016 Leerink Swann Lower Price Target Outperform $45.00 - $40.00
Type messageMakena increased 17% over the prior year, and early data from the recent launch of the new formulation of Makena, including April enrollment data at the Makena Care Connection that is up approximately 50% over March, suggests an acceleration in sales growth. We expect these trends to continue through the remainder of the year and are confirming our annual net product sales guidance for Makena
Huge miss! Will make a new 52 week low. Look for $18 by end of the week. Glta...
Financial Results (Non-GAAP Basis)1,2Non-GAAP revenues totaled $117.9 million in the first quarter of 2016, up from $83.1 million in the first quarter of 2015. Non-GAAP CBR revenue totaled $28.1 million in the first quarter of 2016. The difference between GAAP and non-GAAP revenue for CBR represents purchase accounting adjustments related to deferred revenue. Non-GAAP revenue in 2015 excludes certain non-cash revenue related to the company’s ex-U.S. marketing agreement with its former partner, Takeda Pharmaceutical Company Limited.
Total costs and expenses on a non-GAAP basis totaled $70.4 million resulting in a gross margin of 92% and adjusted EBITDA margin of 40% for the first quarter of 2016. This compares to costs and expenses of $35.7 million in the same period of 2015, which resulted in a gross margin of 96% and adjusted EBITDA margin of 57%. The decline in gross margin resulted from the acquisition of CBR, which carries lower gross margins than the company’s pharmaceutical products. Investments in research and development to enhance the long-term revenue potential of Makena and Feraheme contributed to the lower adjusted EBITDA margin in the first quarter of 2016. Non-GAAP adjusted EBITDA for the first quarter of 2016 was $47.5 million, compared with $47.4 million for the same period in 2015.
After deducting cash interest expense, the company generated first quarter 2016 non-GAAP net income of $32.9 million, or $0.95 per non-GAAP basic share and $0.94 per non-GAAP diluted share. In the first quarter of 2015, non-GAAP net income totaled $40.0 million, or $1.47 per non-GAAP basic share and $1.17 per non-GAAP diluted share.
Balance Sheet HighlightsAs of March 31, 2016, the company’s cash and investments totaled approximately $480 million and total debt (principal amount outstanding) was approximately $1.04 billion.
"We are reiterating our full year 2016 guidance for revenue, adjusted EBITDA and non-GAAP net income, including top-line revenue growth of approximately 40%, which underscores the strong recent trends for Makena and the overall underlying demand we are generating across our portfolio of products,” said Frank Thomas, president and chief operating officer. “During the quarter and throughout 2016, we are investing in our products through R&D to potentially expand our label for Feraheme and provide more patient- and provider-friendly versions of Makena. We believe these investments will enhance the long-term revenue potential of these products.”
Citi cut its price target to $18, noting the company's guiding in Q4 toward a sixth straight decline in revenues. Capacity cuts could lead to an improvement in gross margin (to 27-28% from a current 23%), analyst Stanley Kovler says. “At this level of operating cash flow and despite capex down to 'maintenance' levels, further cash restructuring charges beyond the announced $150 million we see a rising risk of the board of directors and management rethinking its dividend payout."
Wells Fargo also expected a bad quarter, and cut its valuation target to $21-$23 from $28-$32, but are maintaining a Market Perform rating amid some positives including strong current and upcoming near-line demand, and capex expected to stay low in fiscal 2017.
The company's showing demand weakness in mission-critical enterprise drives, PC hard drives and the systems business, Wells says. "Gross margins have been a problem as well, declining 290bps sequentially segmented by a 70bps decline in HDD, 80bps in systems and 180bps from lower utilization."
Elsewhere, Jefferies cut its target to $25 from $29; Maxim Group slashed its target to $25 from $36; JPMorgan Chase downgraded shares and cut its price target to $15 from $30; UBS trimmed to $20 from $22; RBC downgraded to Sector Performa nd cut its target to $24 from $36; and Brean lowered its target to $30
from $50 (but maintained a Buy). Definitely heading to $10
So what? Do you think he dumb enough to pay $400 a share for ICPT? Really? That would put ICPT market cap above $8 Billion. Yell right, good luck on that fool!
FBR Capital analyst Vernon Bernardino reiterated a Market Perform rating and $192 price target on Intercept Pharmaceuticals (NASDAQ: ICPT) after the FDA's Gastrointestinal (GI) Drugs Advisory Committee (GIDAC) supported accelerated approval of obeticholic acid (OCA) as a treatment for primary biliary cholangitis (PBC).
Bernardino commented, "Although the GIDAC panelists had general concerns about the validity of serum alkaline phosphatase (ALP) levels as a surrogate endpoint (SEP), they concluded that there was substantial evidence correlating a reduction in ALP with a meaningful positive effect on disease progression to death and/or liver transplantation in OCA-treated patients. The next steps likely involve discussions on specific post-marketing (Phase IV) confirmatory trial requirements and specific items to include in a proposed label prior to the FDA’s decision whether to approve Ocaliva (OCA’s provisional brand name), which is expected by the PDUFA date of May 29, 2016. We make minor changes in our model to incorporate insights gained from yesterday’s discussion, but as we view upside potential and downside risk in ICPT stock as evenly balanced, we remain at Market Perform."
Please quite the BS, no one is going to buy out ICPT for $400. Thanks God if you get $200
MS downgraded Intercept Pharmaceuticals from Equalweight to Underweight with a price target of $80 (prior $100). Cautious comments from analyst Andrew S Berens followed a favorable FDA panel vote supporting approval of Ocaliva in PBC. Berens believes concerns raised in the panel could impact the drug's label and eventual launch. He also thinks restrictions in cirrhotics could impact Ocaliva's potential in NASH.
"The panel unanimously recommended to approve the drug based on the surrogate endpoint used in the Phase 3 trial, but failed to endorse usage in advanced PBC patients given the lack of data supporting efficacy, as well as safety concerns," said Berens. "According to external consultants, the primary unmet medical need in this patient population is in patients with advanced or aggressive disease, so this lack of an endorsement by the panel has important commercial implications in our opinion, especially if the label is similarly restrictive."
The analyst continued, "The panel also expressed concerns about usage of the drug in patients with cirrhosis given the doserelated liver toxicity noted in the program. Additionally, the panel suggested that a less frequent dosing regimen be used in PBC patients with liver compromise and that patients be discontinued from treatment that do not respond within a specified time (6 or 12 months) given safety and tolerability concerns. We think these restrictions are likely to truncate the commercial PBC opportunity significantly and impact the launch, and therefore have lowered our peak PBC revenues to $117mn from $148mn."
Berens believes these concerns will weigh on ICPT shares ahead of the May 29 FDA action date, with potential for precautionary language in the drug's label.
Discussing NASH in more detail, the analyst said, "...The PBC panel clearly felt the drug was better suited for early stage liver disease without any hepatic compromise, which could be an issue in NASH if the same findings
4/7/2016 Wedbush Reiterated Rating Outperform $423.00
Mizuho Securities downgraded Allergen from Buy to Neutral with a price target of $250.00 (from $330.00),
The arbitrage has been aggressively initiated in recent weeks,then there is going to blood among those arbitragers tomorrow morning.For the purpose of argument,lets assume that all 260 million of the increase in PFE short interest is merger related .That would also mean that arbs held long 23 million shares of AGN.At current prices that translates to loss of 372 million on PFE and 1.16 b on AGN from Fridays close.IF we also assume that %30 of this is option hedged,that translates into over 1 b in total losses..If the deal looks as if it is going to be unwound,a considerable % of the (%70 unhedged * 260m)182 million short position in PFE is going to cover over the near term and the same will hold true with (%70 unhedged*23m) 16 m shares of AGN will be sold .For the last 90 days average daily volume has been running at 42.2 m while AGN's has been 3.3m.Wall St traders who do not have positions in either will smell blood and will not be charitable in their offers and bids and will try to make it as painful as possible for those holding unhedged positions.
If you desire to go long AGN,it might be better to sell slightly out the money puts ,snce the volatility should explode.The same may apply to a lesser extent to PFE's calls