Biogen Idec (BIIB) Says Tecfidera Patient Who Died had Low White Blood Cell Counts Oct 22, 2014 11:52AM

Biogen Idec Inc. (BIIB) is seeing some unnecessary weakness Wednesday following Q3 results and the company's conference call.

Earlier, the WSJ cited the company as saying it confirmed a case of a rare brain infection in a patient who took Tecfidera and recently died from complications of pneumonia.

However, Biogen clarified that what it said was the patient taking Tecfidera who died had low white blood cell counts.

Biogen reported Q3 EPS of $3.80, $0.31 better than the analyst estimate of $3.49. Revenue for the quarter came in at $2.5 billion versus the consensus estimate of $2.48 billion. Tecfidera revenues were $787 million, consisting of $638 million in U.S. sales and $149 million in sales outside the U.S.


Tesla (TSLA) Will Report Q3 Results on Nov. 5th; Street Sees Revenue Doubling Oct 21, 2014 06:09AM

Tesla (Nasdaq: TSLA) announces that it will post its financial results for the third quarter ended September 30, 2014, after market close on Wednesday, November 5, 2014. At that time, Tesla will issue a brief advisory release containing a link to the Q3 2014 Shareholder Letter, available on the company website. Tesla management will hold a live question & answer webcast at 2:30pm Pacific Time (5:30pm Eastern Time) to discuss the Company's financial and business results and outlook.

*** Consensus estimates are looking for breakeven loss on $894 million in revenue, from EPS of $0.12 with revenue of $431 million posted in the same period last year.

What: Tesla Motors, Inc. Q3 2014 Financial Results Q&A Webcast When: Wednesday, November 5, 2014 Time: 2:30pm Pacific Time / 5:30pm Eastern Time Shareholder Letter: http://ir.teslamotors.com Webcast: http://ir.teslamotors.com (live and replay)

Approximately two hours after the Q&A session, an archived version of the webcast will be available on the Company's website for a period of one year.


Horizon Pharma (HZNP) Sees Peak ACTIMMUNE Sales of ~$500M Oct 13, 2014 05:08PM

Horizon Pharma (NASDAQ: HZNP) is hosting analysts and investors this evening to discuss the opportunities for ACTIMMUNE (interferon gamma-1b). ACTIMMUNE is currently approved by the U.S. Food and Drug Administration (FDA) to treat two ultra-rare orphan diseases, Chronic Granulomatous Disease (CDG) and severe, malignant osteopetrosis (SMO).

The meeting is being conducted in King of Prussia, PA to coincide with the Children's Hospital of Philadelphia (CHOP) 7th Annual Friedreich's Ataxia (FA) Symposium. The results from the Phase 2 clinical trial, sponsored by Friedreich's Ataxia Research Alliance (FARA) and conducted by the Collaborative Clinical Research Network in Friedreich's Ataxia (CCRN in FA), were presented at the CHOP event and are being discussed at the Horizon analyst day.

Highlights from the Horizon Pharma meeting include:

  • ACTIMMUNE is currently being used by approximately 270 patients for CGD and SMO.
  • Additional potential indications being evaluated include eczema herpeticum (EH), cutaneous t-cell lymphoma (CTCL), autosomal dominant osteopetrosis (ADO), methicillin resistant staphylococcus aureus (MRSA), as well as FA.
  • FA is a debilitating, life-shortening, degenerative, neuro-muscular disorder that affects about one in 50,000 people in the United States -- with an estimated 4,000 to 5,000 individuals in the U.S. and 15,000 worldwide, according to FARA. There is currently no approved FDA treatment for FA.
  • FARA is currently adding approximately 200 patients per year to its registry and now has over 2,400 FA patients registered.
  • Changes in frataxin protein levels, the primary study endpoint, were statistically significant in red blood cells, white blood cells and platelets, while the magnitude of change observed was small and varied between tissues.
  • Results of the ACTIMMUNE Phase 2 clinical study showed a strong efficacy signal with mean improvement in the clinical outcome measure, the Friedreich's Ataxia Rating Scale (FARS) score, a clinically validated measurement of patient performance and a secondary endpoint. These results were statistically significant (p=0.008) and the mean change in FARS score of subjects in the study improved by an amount equivalent to approximately two years of disease progression.
  • Horizon Pharma is working with FARA and the Collaborative Clinical Research Network in FA to plan the ACTIMMUNE Phase 3 clinical trial in FA.
  • The Company estimates that ACTIMMUNE could potentially achieve $500 million or greater in peak annual net sales opportunity if approved by the FDA for FA along with increased penetration in its currently approved indications in CGD and SMO.

"We are committed to helping patients and physicians identify the early signs and symptoms of CGD and SMO to ensure patients receive more effective treatment sooner," said Timothy P. Walbert, chairman, president and chief executive officer. "We also believe there is a significant potential opportunity in Friedreich's ataxia patients and we are committed to working closely with FARA and CCRN in FA to expeditiously initiate the ACTIMMUNE Phase 3 clinical trial."


Exactech, Inc. (EXAC) Schedules Q3 Conf. Call; Sees Net Income Below Prior Guidance Oct 13, 2014 04:53PM

Exactech, Inc. (NASDAQ: EXAC) will release its third quarter 2014 financial results on Tuesday, October 21st, 2014. A copy of the earnings release will be available at http://www.hawkassociates.com.

The company said it expects that revenue for the third quarter will be at the lower end of its previously announced guidance and that net income will be below guidance due to softer than expected sales and adverse currency impacts.

The company will hold a conference call with CEO David Petty and key members of the management team on Wednesday, October 22nd at 10:00 a.m. Eastern Time. The call will cover Exactech’s third quarter 2014 results. Petty will open the conference call and a question-and-answer session will follow.

To participate in the call, dial 1-888-329-8877 any time after 9:50 a.m. Eastern on Wednesday, October 22nd. International and local callers should dial 1-719-457-2085. A live and archived webcast of the call will be available at http://www.hawkassociates.com/profile/exac.cfm or http://public.viavid.com/index.php?id=111204. This call will be archived for approximately 90 days.


American Airlines Group (AAL) Will Release Q3 Results Oct. 23rd; Street Sees Sequential EPS Growth Oct 13, 2014 03:31PM

American Airlines Group (Nasdaq: AAL) will webcast a live audio feed of its conference call with financial analysts and reporters to discuss third quarter 2014 financial results on Thursday, October 23, at 12:30 p.m. CDT.

*** The Street is currently looking for EPS of $1.66 with revenue of $11.2 billion, from EPS of $1.17 and revenue of $11.4 billion posted in Q214.

The webcast will be available to the public on a listen-only basis at aa.com/investorrelations . An archive of the call will be available on the website through Nov. 24, 2014.


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