Today - Wednesday, October 26, 2016
- EXACT Sciences (EXAS -13%) is down on triple normal volume after reporting Q3 results this morning. Revenues of $28.1M beat the consensus of $25.3M by more than 11% while the EPS loss of ($0.36) was less than the ($0.42) expectation.
- The culprit appears to be softer revenue guidance for the year, now expected to be $93M - 95M, down from $90M - 100M, implying potentially lower revenue pre Cologuard test since the volume outlook remained at ~240K. Based on the revised revenue forecast, Q4 sales should be ~$29M - 31M which would be up ~7% sequentially (from midpoint of range).
- Nano cap Tonix Pharmaceuticals (TNXP -21.2%) slumps on triple normal volume in response to its announcement of a public offering of 9.5M units at $0.55. Each unit consists of one share of common stock and one five-year warrant to purchase 1/2 share of common at $0.63.
- Underwriters over-allotment is an additional 1.425M shares of stock and/or warrants to purchase 712.5K shares of stock at $0.6875.
- Net proceeds will be ~$4.6M. Closing date is October 31.
- Yesterday's close was $0.6201.
- Teva Pharmaceutical Industries (TEVA +0.1%) expands its existing e-Health alliance with IBM leveraging the IBM Watson Health Cloud. The new partnership features a three-year research collaboration to develop cognitive computing technologies that will enable a systematic approach to drug repurposing, an emerging field focused on finding new uses for existing medicines.
- The first targets will be focused on respiratory and central nervous system diseases under the companies' chronic disease management initiative, the first project to integrate data from IBM's The Weather Company into the analyses.
- Teva says that 30% of relatively recent FDA approvals have been for new uses of previously approved drugs and vaccines. A repurposing approach to drug discovery and development would streamline the process since existing medicines have been extensively tested and have well-known safety and efficacy profiles.
- Financial terms are not disclosed.
- Dr. Reddy's Laboratories (RDY +0.2%) enters into a strategic collaboration with Hyderabad, India-based Gland Pharma Limited to distribute and market a portfolio of eight planned injectable generic products in the U.S. The regulatory applications, specifically Abbreviated New Drug Applications (ANDAs), are either currently under review or will be filed shortly.
- According the IMS Heath, the total U.S. market for the eight products is ~$1B.
- Financial terms are not disclosed.
- With the aim of clarifying the requirements to approve drugs to treat women with sexual desire dysfunction, the FDA issued draft guidance yesterday for drug developers. The guidance focuses on conditions of low sexual interest, desire and/or arousal that lead to distress or interpersonal difficulty in women, including female sexual interest/arousal disorder (FSIAD), hypoactive sexual desire disorder (HSDD) and female sexual arousal disorder (FSAD).
- To prove efficacy, the agency maintains its requirement of two randomized pivotal trials. Each study should include at least 24 weeks of blinded treatment to demonstrate the onset and persistence of effect. The agency also recommends a placebo run-in period to gather baseline data and assess the likelihood that the participants will adhere to the proposed dosing regimen. Suggested primary endpoints include the change from baseline in the number of satisfying sexual events (SSEs), the level of sexual interest or desire, the level of sexual arousal and the level of distress.
- The FDA has approved only one such drug thus far, Valeant Pharmaceuticals' (VRX -0.9%) Addyi (flibanserin), which it acquired via its $1B takeover of Sprout Pharmaceutics last year. Sales have been tepid, however, due to the lack of effect in many women and the unwanted side effect of the risk of fainting due to low blood pressure. Women are advised to avoid consuming alcohol in order to minimize the effect, a significant negative.
- Nano cap Palatin Technologies (PTN +0.6%) has a candidate in late-stage development, bremelanotide, that it says has demonstrated no adverse events in women who have consumed alcohol. Phase 3 data are expected by year end.
- Previously: Valeant's $1B investment in female libido pill off to a slow start (Nov. 17, 2015)
- Qiagen N.V. (QGEN +0.7%) shareholders overwhelmingly approve a proposal to return ~$250M in cash to investors via a synthetic share repurchase plan that combines a direct capital repayment with a reverse stock split. The transactions should be completed in early January 2017.
- The synthetic share repurchase plan consists of three steps: 1. the par value of the company's common shares will be increased to allow the capital repayment to shareholders; 2. a reverse split will be executed at a ratio equal to the market value of the total number of shares outstanding minus the capital repayment amount divided by the market value of the total number of outstanding shares; 3. the capital repayment will be paid out to shareholders of record and the par value will be reduced to its original level of €0.01 per share.
- The synthetic approach is similar to a plain vanilla share buyback plan but enables the return of capital to shareholders more quickly than buying shares on the open market.
- Results from a Phase 3 clinical trial showed equivalence between Boehringer Ingelheim's biosimilar candidate and AbbVie's (ABBV -0.6%) HUMIRA (adalimumab) in patients with active rheumatoid arthritis (RA). Secondary endpoints were also met.
- The data will be submitted for presentation at future medical conferences.
- BI is playing catch-up to Amgen's (AMGN +0.4%) Amjevita (adalimumab-atto) which was approved in the U.S. last month.
- Aeterna Zentaris (AEZS -4.4%) hits the enrollment target in its Phase 3 clinical trial assessing Macrilen (macimorelin) as a growth hormone stimulation test for the evaluation of adults with growth hormone deficiency (AGHD), a disorder that affects ~75K people in the U.S., Canada and Europe. If successful, the company plans to resubmit a New Drug Application (NDA) with the FDA in H1 2017.
- The company received a Complete Response Letter (CRL) in November 2014 related to its initial NDA citing the need for additional supporting data.
- Macrilen is a ghrelin("hunger hormone") agonist that stimulates the secretion of growth hormone.
- Thinly traded micro cap Minerva Neurosciences (NASDAQ:NERV) is up 9% premarket on light volume in response to its announcement of positive results from the 24-week, open-label extension phase of its Phase 2b clinical trial assessing lead product candidate MIN-101 for the treatment of patients with negative symptoms of schizophrenia. Data from the core 12-week segment, presented in May, showed a statistically significant improvement in negative symptoms for both the 32 mg and 64 mg doses.
- Results from the extension phase demonstrated a continuous and stable improvement in negative symptoms in schizophrenic patients as measured by the Positive and Negative Syndrome Scale (PANSS). The data also confirmed an extended safety profile for MIN-101, as it was well-tolerated for the entire 36 weeks of the study.
- The development of MIN-101, which principally binds to the receptors 5-HT2A and sigma 2, is ongoing.
- Previously: Minerva Neuro's lead product candidate successful in mid-stage schizophrenia study; shares rocket up 255% premarket (May 26)
- Teleflex (NYSE:TFX) announces that its Arrow VPS Rhythm System has been CE Mark'd in the European Union. The device assists in the placement and confirmation of a catheter tip in the superior vena cava-cavoatrial junction and can be used with a wide range of catheter types. The company says its real-time navigation capabilities eliminate the need for confirmatory chest X-ray or fluoroscopy.
- Results from a Phase 3 clinical trial, SOLO-2, assessing AstraZeneca's (NYSE:AZN) LYNPARZA (olaparib) for the maintenance treatment of platinum-resistant, BRCA mutation-positive ovarian cancer showed treatment with 300 mg twice daily as monotherapy extended progression-free survival (PFS) compared to placebo. The results were clinically meaningful and statistically significant. PFS substantially exceeded what was observed in a Phase 2 study, Study 19, in the same profile of patients.
- Complete data will be submitted for presentation at a future medical conference. Plans for regulatory submissions are in process.
- LYNPARZA inhibits an enzyme called poly ADP-ribose polymerase (PARP). It kills cancer cells by exploiting tumor DNA repair pathway deficiencies. It is approved in over 40 countries for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in partial or complete response to platinum-based chemo. In the U.S. it is approved for patients with deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemo. It is the first PARP inhibitor approved in the U.S.
- Shares are off 1% premarket.
- NeoGenomics (NEO) Q3 results: Revenues: $60.8M; Operating Income: $1.4M; Net Loss: ($5.6M); Loss Per Share: ($0.07); Non-GAAP EPS: $0.04; Quick Assets: $28.9M (+23.5%); CF Ops: $21.7M.
- 2016 Guidance: Revenue: $245M - 250M; Adjusted EBITDA: $36M - 38M; Adjusted Net Income: $13M - 15M from $8M - 13M; Adjusted EPS: $0.14 - 0.16 from $0.08 - 0.13.
- Laboratory Corporation of America (NYSE:LH) Q3 results ($M): Total Revenues: 2,372.7 (+4.5%); Diagnostics: 1,671.8 (+4.4%); Covance: 701.1 (+4.8%).
- Net Income: 179.5 (+16.0%); EPS: 1.71 (+14.0%); Non-GAAP EPS: 2.25 (+8.7%); CF Ops: 249.9 (-13.2%).
- 2016 Guidance: Total Revenue Growth: 10.0 - 11.0% from 9.5 - 10.5%; Diagnostics Revenue Growth: 5.0 - 6.0% from 4.5 - 5.5%; Covance Revenue Growth: 7.5 - 9.0% from 7.0 - 9.0%; Non-GAAP EPS: $8.70 - 8.90 from $8.60 - 8.95; FCF: $840M - 880M from $900M - 950M.
- Boston Scientific (BSX -2.3%) Q3 results: Revenues: $2,105M (+11.5%); Cardiovascular: $825M (+13.5%); Rhythm Management: $527M (+3.7%); MedSurg: $753M (+15.3%).
- Interventional Cardiology: $568M (+13.6%); Peripheral Interventions: $257M (+13.2%); Cardiac Rhythm Management: $467M (+3.5%); Electrophysiology: $60M (+5.3%); Endoscopy: $367M (+10.9%); Urology and Pelvic Health: $248M (+25.3%); Neuromodulation: $138M (+11.3%).
- Operating Income: $348M (-216.4%); Net Income: $228M (-215.2%); EPS: $0.17 (-213.3%); Non-GAAP EPS: $0.27 (+12.5%); Quick Assets: $237M (-25.7%).
- 2016 Guidance: Revenues: $8.335B - 8.385B from $8.27B - 8.37B; EPS: $0.32 - 0.34 from $0.30 - 0.35; Non-GAAP EPS: $1.09 - 1.11 from $1.07 - 1.11.
- Q4 Guidance: Revenues: $2.14B - 2.19B; EPS: $0.15 - 0.17; Non-GAAP EPS: $0.27 - 0.29.
- Shares are up 3% premarket on light volume.
7:57 AM| 7:57 AM | 1 Comment
- GlaxoSmithKline Q3 results (₤M): Total Revenues: 7,542 (+23.1%); Pharmaceuticals: 4,061 (+49.4%); HIV: 940 (+51.1%); Vaccines: 1,613 (+36.6%); Consumer Healthcare: 1,868 (+18.5%).
- Sales by Segment: Respiratory: 1,589 (+24.9%); Cardio, metabolic, urology: 206 (-8.4%).
- Consumer Healthcare: Wellness: 964 (+18.6%); Oral Health: 570 (+23.9%); Nutrition: 187 (+8.7%); Skin Health: 147 (+12.2%).
- Seretide/Advair Sales: 857 (+7.9%).
- Net Income : 808 (+50.2%); EPS: 0.166 (+49.5%); CF Ops: 1,767 (+267.4%).
- 2016 Guidance: EPS Growth: 11 - 12% (unch).
- Shares are off a fraction premarket.
- Biogen (NASDAQ:BIIB) Q3 results ($M): Total Revenues: 2,955.8 (+6.4%); Product Sales: 2,539.6 (+6.2%); Joint Business: 317.6 (-5.8%).
- Net Income: 1,032.9 (+7.0%); Non-GAAP Net Income: 1,137.7 (+9.2%); EPS: 4.71 (+13.5%); Non-GAAP EPS: 5.19 (+15.8%).
- Key Product Sales: Tecfidera: 1,033.7 (+4.1%); Total Interferon: 708.3 (+3.4%); Tysabri: 515.5 (+3.6%); Eloctate: 131.8 (+45.5%); Alprolix: 85.2 (+29.7%).
- Novo Nordisk (NYSE:NVO) submits a supplemental New Drug Application (sNDA) in the U.S. and a Type II Variation application in Europe seeking approval to add the cardiovascular (CV) outcomes data generated from the LEADER study in type 2 diabetics to the package insert of diabetes med Victoza (liraglutide).
- Results from LEADER showed treatment with Victoza reduced the risk of CV death, non-fatal myocardial infarction (heart attack) and non-fatal stroke by 13% compared to placebo when added to standard of care. The overall risk reduction was derived from a statistically significant reduction of 22% in CV death versus placebo and non-statistically significant reductions in non-fatal heart attack and stroke. The large scale study (9,000+ participants) was initiated in mid-2010.
- This is only the second time a diabetes medication has demonstrated a CV benefit. Eli Lilly (NYSE:LLY) and Boehringer Ingelheim's Jardiance (empagliflozin) was the first.
- Previously: Trial results show Novo Nordisk's type 2 diabetes drug Victoza reduces risk of cardiovascular events; shares up 8% premarket (March 4)
- Nintendo (OTCPK:NTDOY) revealed an operating loss of ¥5.95B in the period from March to September, while lowering its outlook and dividend.
- A hard landing! Airbus (OTCPK:EADSY) missed forecasts on supply chain issues, but the aircraft maker maintained its full year guidance.
- Brazil provided some bright side for Santander (NYSE:SAN) as a pick-up in performance lifted earnings above expectations, offsetting Brexit concerns.
- Provisions ate into the quarterly profit at Lloyds (NYSE:LYG), as the bank set aside another £1B to pay compensation for mis-sold payment protection insurance.
- Bayer (OTCPK:BAYRY) raised guidance for the full year on strong pharma results in its first quarterly scorecard since securing the Monsanto merger.
Tuesday, October 25, 2016
- Vertex Pharmaceuticals (NASDAQ:VRTX) is up 6% after hours on robust volume. Q3 revenues were up nicely, yes, but also stoking buying is its announcement of two new Phase 2 studies assessing next-generation correctors for the treatment of cystic fibrosis (CF). Both should commence by year end.
- One Phase 2 will assess the safety and efficacy of a four-week dosing regimen of VX-440, in combination with tezacaftor (VX-661) and KALYDECO (ivacaftor), in ~40 CF patients who have one F508del mutation and one minimal function mutation and ~25 CF patients with two copies of the F508del mutation. Top-line data are expected in H2 2017 and will support the advancement into Phase 3 development.
- The other Phase 2 will evaluate two weeks of triple combination dosing with VX-152 in ~35 CF patients with one F508del mutation and one minimal function mutation and ~25 CF patients with two copies of F508del. Top-line data are also expected in H2 2017 and will support the advancement into a longer-term Phase 2b study or registration program.
- The company has also plans to initiate a Phase 1 study of VX-659 by year end with a Phase 2 trial on tap for H2 2017.
- NuVasive (NASDAQ:NUVA) Q3 results ($M): Revenues: 239.6 (+19.5%).
- Net Income: 3.9 (-69.7%); Non-GAAP Net Income: 21.1; EPS: 0.07 (-70.8%); Non-GAAP EPS: 0.40; CF Ops (9 mo.): 96.0 (+100.0%).
- 2016 Guidance: Revenue: ~$952M from ~$962M; EPS: 0.76 from 0.84; Non-GAAP EPS: ~$1.64 (unch).
- Revenues 1.6% shy of $243.5M consensus. Non-GAAP EPS in line with consensus.
- Shares are down 11% after hours on increased volume.
- USANA Health Sciences (NYSE:USNA) Q3 results ($M): Sales: 254.2 (+9.0%); Americas & Europe: 63.8 (-2.0%); Greater China: 124.5 (+10.9%); Asia Pacific Total: 190.4 (+13.2%); Southeast Asia Pacific: 54.4 (+18.3%); North Asia: 11.6 (+16.5%).
- Active Associates (000s): Americas & Europe: 87 (-2.2%); Greater China: 263 (+20.6%); Asia Pacific Total: 369 (+16.8%); Southeast Asia Pacific: 91 (+7.1%); North Asia: 15 (+15.4%).
- Active Preferred Customers (000s): Americas & Europe: 64 (+1.6%); Asia Pacific Total: 30 (+15.4%); Greater China: 5 (+25%); Southeast Asia Pacific: 15 (+15.4%); North Asia: 10 (+11.1%).
- Net Income: 30.1 (+17.5%); EPS: 2.40 (+25.0%).
- 2016 Guidance: Sales: $1.0B - 1.01B from $1.02B - 1.05B; EPS: $7.90 - 8.10 from $7.90 - 8.20.
- Sales were 3.5% short of $263.4M consensus while EPS was 12.7% above $2.13 consensus.
- ResMed (NYSE:RMD) fiscal Q1 results ($M): Revenues: 465.5 (+13.1%).
- Net Income: 76.1 (-8.2%); Non-GAAP Net Income: 87.7 (+3.6%); EPS: 0.54 (-6.9%); Non-GAAP EPS: 0.62 (+5.1%); CF Ops: 86.2 (-30.8%).
- No guidance given.
- Revenues were 1.9% below consensus of $474.7M. Non-GAAP EPS was 3.1% short of consensus of $0.64.
- Shares unchanged after hours.
- C.R. Bard (NYSE:BCR) Q3 results ($M): Total Revenues: 941.9 (+8.8%); Vascular: 258.1 (+3.0%); Urology: 242.1 (+14.0%); Oncology: 258.4 (+8.0%); Surgical Specialties: 158.8 (+13.6%).
- Net Income: 96.4 (+212.1%); Non-GAAP Net Income: 199.5 (+14.2%); EPS: 1.27 (+209.5%); Non-GAAP EPS: 2.64 (+15.8%).
- 2016 Guidance: Revenue Growth: 8 - 9%; Non-GAAP EPS: $10.23 - 10.28.
- Q3 revenues were 1.1% above consensus of $931.7M and non-GAAP EPS was 3.5% above consensus of $2.55.
- Q4 consensus is non-GAAP EPS of $2.74 on revenues of $943.4M.
- Edwards Lifesciences (NYSE:EW) Q3 results ($M): Revenues: 739.4 (+20.1%); Transcatheter Heart Valve Therapy: 410.1 (+38.5%); Surgical Heart Valve Therapy: 190.9 (+1.6%); Critical Care: 138.4 (+5.2%).
- Net Income: 141.4 (+19.7%); Non-GAAP Net Income: 148.2 (+24.9%); EPS: 0.65 (+20.4%); Non-GAAP EPS: 0.68 (+25.9%).
- 2016 Guidance: Revenues: high end of $2.7 - 3.0B (unch); Non-GAAP EPS: 2.82 - 2.92 from 2.78 - 2.88.
- Q4 Guidance: Revenues: $750M - 790M; Non-GAAP EPS: $0.67 - 0.77.
- Revenues were 1.3% below consensus of $749.1. Non-GAAP EPS met consensus.
- Shares are down 17% after hours on robust volume.
- Vertex Pharmaceuticals (NASDAQ:VRTX) Q3 results ($M): Total Revenues: 413.8 (+33.6%); Product Revenues: 409.7 (+35.4%).
- Net Income: (41.8) (+56.0%); Non-GAAP Net Income: 40.1 (+225.7%); EPS: (0.17) (+56.4%); Non-GAAP EPS: 0.16 (+223.1%).
- Key Product Sales: ORKAMBI: 234.0 (+78.6%); KALYDECO: 175.6 (+5.8%).
- 2016 Guidance: ORKAMBI Sales: $950M - 990M (unchanged from September update but lower than previous outlook of $1.0B - 1.1B); KALYDECO Sales: $685M - 705M (unch).
- Express Scripts (NASDAQ:ESRX) Q3 results ($M): Total Revenues: 25,410.1 (+0.1%).
- EBITDA: 1,948.1 (+11.7%); Non-GAAP EBITDA: 1,948.1 (+7.7%); Net Income: 722.9 (+9.2%); Non-GAAP Net Income: 1,091.6 (+10.3%); EPS: 1.15 (+18.6%); Non-GAAP EPS: 1.74 (+20.0%); CF Ops (9 mo.): 2,670.5 (+35.3%).
- Claims Volume: 247.0 (-6.0%); Generic Fill Rate: 85.4% (+1.1%).
- 2016 Guidance: EPS: $4.47 - 4.53 from $4.45 - 4.55; Non-GAAP EPS: $6.36 - 6.42 from $6.33 - 6.43; Operating Income: $5,105 - 5,180 from $5,135 - 5,250; Total Adjusted Claims: 1,265 - 1,280 from 1,260 - 1,290.
- Q4 Guidance: EPS: $1.38 - 1.44; Non-GAAP EPS: $1.84 - 1.90.
- 2017 Guidance: Retention rate: 97 - 98% from 96 - 98%.
- Shares are up 2% after hours on average volume.
- The market's down day notwithstanding, Concordia International (CXRX -6.9%) slumps on modestly higher volume in apparent response to its announcement that its international segment is involved in a pricing inquiry by the UK Competition and Markets Authority (CMA). The company says the investigation includes matters that pre-date its ownership of the international business that it acquired in its October 2015 takeover of Amdipharm Mercury Limited.
- CMA is a non-ministerial department that promotes competition within and outside the United Kingdom. It says it has not decided on whether there is sufficient evidence of infringement that would be the basis to issue a statement of objections.
- Thinly traded nano cap Opgen (OPGN -20.2%) is down on almost double normal volume in response to its Q3 results released after yesterday's close. Revenue was $759.7K, down 22.5% from a year earlier. Net loss was $4.8M, 4% worse yoy. Quick assets at quarter end were $4.3M, down over 45% from year end 2015.
- The company employs DNA tests and bioinformatics to help clinicians manage life-threatening bacterial infections. It offers its Acuitas MDRO Gene Test and Acuitas Resistome Test through its CLIA-certified diagnostic laboratory.
- Thinly traded nano cap Calithera Biosciences (CALA -20.3%) slumps on more than triple normal volume, albeit on turnover of only 513K shares, on the heels of Citigroup's Sell rating, a rare occurrence for new coverage. Four other shops rate it a Buy. Citi's price target is $1, implying downside risk of 57%.
- The company's lead product candidate is a glutaminase inhibitor called CB-839, in early-stage development in a range of cancers. Last year, data from a Phase 1 study in kidney cancer underwhelmed investors by showing stable disease over a short time period and only one partial responder.
- Its second pipeline candidate is arginase inhibitor CB-1158. Data from a Phase 1 study in advanced solid tumors should be available next year.
- TheStreet's Adam Feuerstein says Corbus (NASDAQ:CRBP) is “headed for a big fall,” citing an unidentified healthcare fund manager who previously shorted Mast Therapeutics, CytRx, Immunomedics and others.
- Resunab, the only drug in Corbus' research pipeline, doesn't work, he says.
- Corbus is due to announce top-line results from mid-stage clinical trial of resunab later this quarter.
- Shares have gone from $1.50 in Jan. to almost $10 earlier this month. Today they're -23% to $6.85.
- For contrast, here are JMP and Noble's notes on CRBP.
- See J.P.Morgan note here
- JPM has a $13 price target on SGMO (vs. current $3.85).
- Says SGMO's hemophilia therapy may be more potent than BioMarin and Spark's.
- Thinly traded micro cap Second Sight Medical (NASDAQ:EYES) is up 22% premarket on increased volume in response to its announcement of the first successful human implantation and activation of a wireless visual cortical stimulator. The patient, implanted at UCLA Medical Center, is able to perceive and localize individual phosphenes (spots) of light with no camera and no significant adverse side effects.
- The event provides the initial proof of concept for the company's Orion I Visual Cortical Prosthesis. The device is designed to restore useful vision by directly stimulating the visual cortex of the brain and bypassing the optic nerve. It is intended for patients who cannot benefit from the Argus II Retinal Prosthesis.
- The company says it expects to file an application with the FDA in 2017 seeking approval to conduct an initial clinical trial of the complete Orion I system, including the camera and glasses.
- Thinly traded micro cap Dipexium Pharmaceuticals (NASDAQ:DPRX) plunges 85% premarket on robust volume in response to its announcement that both pivotal Phase 3 clinical trials, OneStep-1 and OneStep-2, assessing lead product candidate Locilex (pexiganan cream 0.8%) for the treatment of mild infections of diabetic foot ulcers failed to show superiority over vehicle (placebo) plus standard wound care.
- Locilex also failed to show any meaningful difference in wound closure rate versus vehicle and neither study demonstrated a higher rate of bacteria eradication in the Locilex arm, a secondary endpoint. Adding to the bad news were higher-than-expected serious adverse events in the treatment arm, specifically osteomyelitis (bone infection) and cellulitis (bacterial skin infection).
- CEO David Luci says, "Although we are disappointed with these results, we are continuing to evaluate the data and will consider potential regulatory pathways forward in other possible indications based on an evaluation of all data emerging from the Phase 3 studies."
- Locilex is chemically synthesized 22-amino acid peptide isolated from the skin of the African Clawed Frog. According to the company, it kills microbial targets by disrupting cell membrane permeability. Its value proposition is the (supposed) ability to kill a broad spectrum of Gram-positive, Gram-negative, aerobic and anerobic bacteria as well as fungi. It is formulated as an odorless topical cream.
- RTI Surgical (RTIX) Q3 results: Revenues: $66.5M; Operating Loss: ($3.3M) (-155.0%); Net Loss: ($4.5M); Loss Per Share: ($0.08); Non-GAAP EPS: $0.00; Quick Assets: $11.6M (-7.9%); CF Ops: ($3.2M) (+25.6%).
- 2016 Guidance: Revenues: $268M - 270M from $274M - 280M; GAAP Loss Per Share: $0.11 - 0.13 from $0.03 - 0.06; Non-GAAP EPS: $0.09 - 0.12.
- Centene (NYSE:CNC) Q3 results ($M): Total Revenues: 10,846 (+86.3%); Premium: 9,625 (+93.2%); Service: 590 (+22.9%); Premium Tax and Health Insurer Fee: 631 (+76.3%);
- Net Income: 145 (+55.9%); EPS: 0.84 (+12.0%); Non-GAAP EPS: 1.11 (+27.6%); CF Ops: 255 (9 mo.): 255 (-44.2%);
- Operating Expenses: 10,504 (+86.3%); Medical Costs: 8,376 (+88.9%); Health Benefits Ratio: 87.0% (-2.2%).
- 2016 Guidance: Total Revenues: $39.4B - 40.0B (unch); EPS: $2.73 - 2.83 from $2.65 - 3.00; Non-GAAP EPS: 4.28 - 4.38 from $4.20 - 4.55.
- Q4 Guidance: EPS: $0.83 - 0.93; Non-GAAP EPS: $1.05 - 1.15.
- Baxter International (BAX +0.5%) Q3 results: Revenues: $2,558M (+2.9%); Renal: $977M (+3.6%); Hospital Products: $1,581M (+2.4%); Operating Income: $186M (+102.2%); Net Income: $127M; EPS: $0.23; Non-GAAP EPS: $0.56 (+36.6%); Quick Assets: $240M (-4.4%); CF Ops: $183M (-18.3%).
- 2016 Guidance: Sales Growth: ~2% on reported basis; EPS before special items: $1.88 - 1.91.
- Q4 Guidance: Sales Growth: ~2% on reported basis; EPS before special items: $0.49 - 0.52.
- Shares up 3% premarket.
- Merck (NYSE:MRK) Q3 results ($M): Total Revenues: 10,536 (+4.6%): Pharmaceutical: 9,443 (+5.8%); Animal Health: 865 (+4.8%).
- Net Income: 2,184 (+19.6%); Non-GAAP Net Income: 2,989 (+9.9%); EPS: 0.78 (+21.9%); Non-GAAP EPS: 1.07 (+11.5%).
- Key Product Sales: Januvia: 1,006 (-0.8%); Gardasil/Gardasil 9: 860 (+37.6%); Zetia: 671 (+6.0%); Janumet: 548 (-2.5%); Proguad, MMRII & Varivax: 496 (+27.2%); Isentress: 372 (-1.3%); Keytruda: 356 (+1.1%); Cubicin: 320 (-1.5%); Remicade: 311 (-29.6%); Vytorin: 273 (-9.6%); Singulair: 239 (+18.9%); Zostavax: 190 (+6.1%); Zapatier: 164.
- 2016 Guidance: Revenues: $39.7B - 40.2B from $39.1B - 40.1B; EPS: $2.02 - 2.09 from $1.98 - 2.08; Non-GAAP EPS: $3.71 - 3.78 from $3.67 - 3.77.
- Eli Lilly (NYSE:LLY) Q3 results ($M): Total Revenues: 5,191.7 (+4.7%); Animal Health: 706.2 (-9.3%).
- Net Income: 778.0 (-2.7%); Non-GAAP Net Income: 931.0 (-2.0%); EPS: 0.73 (-2.7%); Non-GAAP EPS: 0.88 (-1.1%).
- Key Product Sales: Humalog: 640.8 (-9.1%); Cialis: 588.2 (+3.9%); Alimta: 570.4 (-9.2%); Forteo: 391.2 (+12.1%); Humulin: 322.0 (+1.7%); Cymbalta: 313.5 (+29.1%); Trulicity: 243.6 (+230.5%); Strattera: 198.8 (+1.0%); Erbitux: 184.6 (+114.9%); Cyramza: 159.0 (+43.0%); Zyprexa: 148.9 (-37.4%); Effient: 127.7 (-3.3%).
- 2016 Guidance: Revenue: $20.8B - 21.2B (unch); EPS: $2.66 - 2.76 from $2.68 - 2.78; Non-GAAP EPS: $3.50 - 3.60 (unch).
- Novartis (NYSE:NVS) Q3 results ($M): Total Revenues: 12,126 (-1.1%); Innovative Medicines: 8,173 (-1.0%); Alcon: 1,436 (-2.2%); Sandoz: 2,517 (-1.0%).
- Oncology: 3,235 (-6.2%); Ophthalmology: 1,370 (-0.2%); Est. Medicines: 1,121 (-17.5%); Neuroscience: 924 (+3.9%); Immunology & Dermatology: 770(+37.7%); Respiratory: 390 (+18.9%); Cardio-Metabolic: 363 (+22.2%).
- Net Income: 1,945 (+2.6%); EPS: 0.81 (+5.2%); CF Ops: 3,231 (+3.4%).
- Key Product Sales: Gleevec/Glivec: 834 (-29.6%); Gilenya: 790 (+13.5%); Lucentis: 456 (-6.0%); Tasigna: 441 (+6.0%); Sandostatin: 413 (-1.4%); Afinitor/Votubia: 393 (-5.1%); Galvus: 306 (+8.9%); Cosentyx: 301 (+242.0%).
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