On October 26, 2017 Alkermes plc (NASDAQ: ALKS) reported financial results for the third quarter of 2017 (Press release, Alkermes, OCT 26, 2017, View Source;p=RssLanding&cat=news&id=2311524 [SID1234521192]).

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"Our third quarter results reflect solid year-over-year topline growth of more than twenty percent and disciplined expense management. We continue to focus on executing on our business strategy to grow our commercial products and invest in the late-stage development programs that we expect will be the growth drivers for the future," commented James Frates, Chief Financial Officer of Alkermes. "As we head into the final months of the year, today we are reiterating our guidance for non-GAAP results and improving guidance for GAAP net loss. These expectations reflect reduced revenues, largely due to VIVITROL sales growth being slightly lower than expected in the third quarter, offset by lower cost forecasts."

"VIVITROL and ARISTADA both operate in markets where there remains significant unmet patient need. With new health and economic data being generated to support the long-term potential of these important medicines, we continue to progress VIVITROL and ARISTADA and work toward ensuring access for the patients that need these medicines," said Richard Pops, Chief Executive Officer of Alkermes. "Looking ahead, 2018 will be a transformative year for Alkermes’ proprietary development pipeline, with key events across the development portfolio, highlighted by FDA review of the ALKS 5461 NDA, the phase 3 data readout for ALKS 3831, submission of the ALKS 8700 NDA and important phase 1 data for ALKS 4230."

Quarter Ended Sept. 30, 2017 Highlights

Total revenues for the quarter were $217.4 million. This compared to $180.2 million for the same period in the prior year.
Net loss according to generally accepted accounting principles in the U.S. (GAAP) was $36.3 million, or a basic and diluted GAAP loss per share of $0.24, for the quarter. This compared to GAAP net loss of $62.7 million, or a basic and diluted GAAP loss per share of $0.41, for the same period in the prior year.
Non-GAAP net income was $4.2 million, or a non-GAAP basic and diluted earnings per share of $0.03. This compared to non-GAAP net loss of $14.1 million, or a non-GAAP basic and diluted loss per share of $0.09, for the same period in the prior year.
Quarter Ended Sept. 30, 2017 Financial Results

Revenues

Net sales of VIVITROL were $69.2 million, compared to $55.8 million for the same period in the prior year.
Net sales of ARISTADA were $24.5 million, compared to $14.0 million for the same period in the prior year.
Manufacturing and royalty revenues from RISPERDAL CONSTA, INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA were $79.4 million, compared to $73.3 million for the same period in the prior year.
Manufacturing and royalty revenues from AMPYRA/FAMPYRA1 were $24.5 million, compared to $12.9 million for the same period in the prior year.
Costs and Expenses

Operating expenses were $255.7 million, compared to $241.4 million for the same period in the prior year, reflecting increased investment in the company’s development pipeline and commercial organization.
Balance Sheet
At Sept. 30, 2017, Alkermes had cash and total investments of $568.9 million, compared to $560.8 million at June 30, 2017. At Sept. 30, 2017, the company’s total debt outstanding was $282.0 million.

Financial Expectations
Alkermes is updating its financial expectations for 2017 to reflect year-to-date results and expectations for the fourth quarter of 2017. The following outlines Alkermes’ updated financial expectations for 2017.

Revenues: The company now expects total revenues to range from $850 million to $880 million, reduced from a previous range of $870 million to $920 million. Included in this total revenue expectation, the company now expects VIVITROL net sales to range from $265 million to $275 million, reduced from a previous range of $280 million to $300 million.
Cost of Goods Manufactured and Sold: The company continues to expect cost of goods manufactured and sold to range from $150 million to $160 million.
Research and Development (R&D) Expenses: The company now expects R&D expenses to range from $400 million to $420 million, reduced from $405 million to $435 million, reflecting the timing of certain expenses related to various ongoing programs.
Selling, General and Administrative (SG&A) Expenses: The company now expects SG&A expenses to range from $410 million to $430 million, reduced from $425 million to $455 million, reflecting disciplined expense management and the timing of certain commercial initiatives.
Amortization of Intangible Assets: The company continues to expect amortization of intangibles to be approximately $60 million.
Net Interest Expense: The company continues to expect net interest expense to be approximately $10 million.
Other Income, Net: The company now expects net other income of approximately $10 million.
Income Tax Benefit: The company now expects an income tax benefit of approximately $5 million, improved from an income tax expense of up to $10 million.
GAAP Net Loss: The company now expects GAAP net loss to range from $160 million to $190 million, or a basic and diluted loss per share of $1.04 to $1.23, based on a weighted average basic and diluted share count of approximately 154 million shares outstanding. This compares to previous expectations of GAAP net loss in the range of $180 million to $210 million, or a basic and diluted loss per share of $1.17 to $1.36, based on a weighted average basic and diluted share count of approximately 154 million shares outstanding.
Non-GAAP Net Income (Loss): The company continues to expect its non-GAAP financial measure to be in the range of non-GAAP net loss of $15 million to non-GAAP net income of $15 million. This equates to a non-GAAP basic loss per share of $0.10 to a non-GAAP basic income per share of $0.10, based on a weighted average basic share count of approximately 154 million shares outstanding, and a non-GAAP diluted loss per share of $0.10 to a non-GAAP diluted income per share of $0.09, based on a weighted average diluted share count of approximately 161 million shares outstanding.
Capital Expenditures: The company now expects capital expenditures to range from $50 million to $60 million, reduced from $70 million to $80 million.
Conference Call
Alkermes will host a conference call and webcast presentation with accompanying slides at 8:30 a.m. ET (1:30 p.m. BST) on Thursday, Oct. 26, 2017, to discuss these financial results and provide an update on the company. The webcast player may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 888 424 8151 for U.S. callers and +1 847 585 4422 for international callers. The conference call ID number is 6037988. A replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. BST) on Thursday, Oct. 26, 2017 through 5:00 p.m. ET (9:00 p.m. GMT) on Thursday, Nov. 2, 2017, and may be accessed by visiting Alkermes’ website or by dialing +1 888 843 7419 for U.S. callers and +1 630 652 3042 for international callers. The replay access code is 6037988.

On October 26, 2017 GeneCentric Therapeutics reported that it will present data on the potential of non-small cell lung cancer (NSCLC) biologic subtypes based on its Cancer Subtyping Platform (CSP) to provide novel biomarkers for response to PARP inhibitors (Press release, GeneCentric Therapeutics, OCT 26, 2017, View Source [SID1234521242]). The data will be presented at a poster session during the 2017 American Association for Cancer Research (AACR) (Free AACR Whitepaper) – National Cancer Institute – European Organization for Research and Treatment of Cancer (AACR-NCI-EORTC) (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Therapeutics being held October 27-30, 2017 at the Philadelphia Convention Center, Philadelphia, PA.

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GeneCentric’s core CSP technology is based on generating high resolution, genomic-defined cancer subtypes that characterize disease-related molecular pathways and immune cell expression, and employing the subtypes as biomarkers for response to specific drugs. To date the company has generated subtype-based profilers for NSCLC, head and neck, and bladder cancers.

In the research to be presented at the AACR (Free AACR Whitepaper)-NCI-EORTC meeting company scientists evaluated the potential susceptibility of GeneCentric lung adenocarcinoma and lung squamous cell carcinoma gene expression subtypes to PARP inhibitors. By examining differential expression of homologous recombination genes and several previously published BRCAness signatures, the study identifies subtype-associated differences that might inform likely response to PARP inhibitors, an emerging class of drugs targeting DNA damage response. The researchers show that variable expression of DNA damage response genes in lung squamous cell carcinoma is maintained following adjustment for proliferation and BRCAness signatures, suggesting underlying biologic differences in lung squamous cell carcinoma subtype susceptibility to DNA damage response inhibitors. Confirmation of these findings via prospective cohorts could substantiate their utility as novel biomarkers for PARP inhibitor response.

Details of the presentation are as follows:

Title: “Differences in BRCAness/PARP inhibitor response signatures and homologous recombination
gene expression across lung adenocarcinoma and squamous cell carcinoma gene expression subtypes.”
Poster Number: 37
Abstract Number: A037
Date: Saturday, October 28, 2017
Time: 12:30 PM – 4:00 PM ET
Location: Hall E, Pennsylvania Convention Center
Presenter: Hawazin Faruki, DrPH, Chief Scientific Officer, GeneCentric

To read the abstract, please visit: View Source!/4557/presentation/144

On October 26, 2017 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported financial results for the third quarter ending September 30, 2017 (Press release, Integra LifeSciences, OCT 26, 2017, View Source [SID1234521199]).

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Highlights
•
Third quarter revenue increased 11.4% to $278.8 million over the same quarter in the prior year, and organic revenue increased 1.5%. The recent storms had a negative impact of approximately $7 million in the third quarter. Derma Sciences contributed $24.1 million of revenue in the quarter;
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Third quarter GAAP earnings per share was $0.04, down from prior year quarter largely due to acquisition and integration related expenses. Third quarter adjusted earnings per share was $0.45, compared to $0.46 in the same quarter in the prior year;
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Third quarter cash flow from operations was $45.2 million, a slight decrease from $46.8 million in the prior year’s quarter due to higher cash outlays for acquisition and integration expenses. Trailing twelve-month free cash flow conversion was 70.8%, compared to 75.6% in the prior-year period;

•
The company is revising its full-year 2017 revenue guidance to a new range of $1.165 billion to $1.175 billion, primarily reflecting the addition of the Codman Neurosurgery business acquired from Johnson & Johnson. This results in a full-year 2017 reported revenue growth range of 17.4% to 18.4%;
•
The company is lowering its 2017 full-year organic sales growth to about 4%, from its previous guidance of 6.0% to 7.0%, reflecting the impact from storm-related disruptions and lower base business sales growth; and
•
The company is revising 2017 full-year GAAP earnings per share to a new range of $0.24 to $0.30 and adjusted earnings per share guidance to a new range of $1.83 to $1.87.

Total revenues for the third quarter were $278.8 million, reflecting an increase of $28.5 million, or 11.4%, over the third quarter of 2016. Sales in Orthopedics and Tissue Technologies increased by 25.5%, which includes the acquired revenues from Derma Sciences and strength in our regenerative and orthopedic total ankle and shoulder portfolios. Sales in Specialty Surgical Solutions increased 3.4% compared to the third quarter of 2016. The increase resulted from strength in global tissue ablation sales driven by the recent launch of CUSA Clarity.
Excluding the revenue contribution from acquisitions and the effect of currency exchange rates and discontinued products, total organic revenues increased 1.5% over the third quarter of 2016. Excluding the impact of the recent storms, organic growth was approximately 4.4%.
"Despite the challenges that we encountered during the third quarter, we were able to mitigate much of the impact on adjusted earnings per share with tighter expense controls, resulting in better than expected cash flows," said Peter Arduini, Integra’s president and chief executive officer. "We are pleased to have closed the acquisition of Codman Neurosurgery and look forward to the increased scale and profitability that this strategic deal enables."
The company reported GAAP net income of $3.2 million, or $0.04 per diluted share, for the third quarter of 2017, compared to a GAAP net income of $20.1 million, or $0.25 per diluted share, in third quarter of 2016. The decline primarily reflects expenses associated with the Derma Sciences and Codman Neurosurgery transactions.
The adjusted measures discussed below are computed with the adjustments to GAAP reporting set forth in the attached reconciliation.
Adjusted EBITDA for the third quarter of 2017 was $63.0 million, or 22.6% of revenue, compared to $58.6 million, or 23.4% of revenue, in the third quarter of 2016. The decrease in adjusted EBITDA margin on a year-over-year basis primarily results from dilution from Derma Sciences.
Adjusted net income for the third quarter of 2017 was $36.1 million, unchanged from the prior year quarter. Adjusted earnings per share for the third quarter of 2017 were $0.45, a decrease of 2.2% over the prior year quarter.
2017 Full-Year Outlook
The company is adjusting its full-year 2017 revenue guidance to a new range of $1.165 billion to $1.175 billion, from $1.125 billion to $1.140 billion, primarily reflecting the addition of sales from the Codman acquisition in the fourth quarter. The company is reiterating Codman’s fourth quarter revenue contribution of $60 million to $65 million, net of divestitures. The company is revising its full-year GAAP earnings per share guidance to a new range of $0.24 to $0.30 from its previous range of $0.49 to $0.55. Adjusted earnings per share guidance is being revised to a new range of $1.83 to $1.87 from its previous range of $1.88 to $1.94, entirely because of storm related disruptions.
Based on third quarter results and the outlook for the remainder of the year, the company is revising its full-year 2017 organic revenue growth to about 4%, down from its previous range of 6.0% to 7.0%, which reflects storm related disruptions of approximately 1.5% and lower growth in the base business of approximately 1%.
"We expect some storm-related disruptions to continue to impact revenues in the fourth quarter as production at our manufacturing facility and local infrastructure in Puerto Rico gradually return to full operating capacity," said Glenn Coleman, Integra’s chief financial officer. "Full-year 2017 organic revenue growth is now expected to be about 4%, which reflects the impact from the storms and slower run rates in our dural repair and SurgiMend product lines."

In the future, the company may record, or expects to record, certain additional revenues, gains, expenses, or charges as described in the Discussion of Adjusted Financial Measures below, which will be excluded from the calculation of adjusted EBITDA, adjusted earnings per share for historical periods and in adjusted earnings per share guidance.

Conference Call and Presentation Available Online
Integra has scheduled a conference call for 8:30 AM ET today, Thursday, October 26, 2017, to discuss financial results for the third quarter and forward-looking financial guidance. The conference call will be hosted by Integra’s senior management team and will be open to all listeners. Additional forward-looking information may be discussed in a question and answer session following the call.
Integra’s management team will reference a presentation during the conference call. The presentation can be found on investor.integralife.com.
Access to the live call is available by dialing (323) 794-2551 and using the passcode 6660907. The call can also be accessed via a webcast link provided on investor.integralife.com. A replay of the call will be available through October 30, 2017, by dialing (719) 457-0820 and using the passcode 6660907. The webcast will also be archived on the website.

On October 26, 2017 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that it will report third quarter 2017 financial results on Thursday, November 2, 2017. Karyopharm’s management team will host a conference call and audio webcast at 8:30 a.m. ET on Thursday, November 2, 2017 to discuss the financial results and recent business developments (Press release, Karyopharm, OCT 26, 2017, View Source [SID1234521226]).

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To access the conference call, please dial (855) 437-4406 (local) or (484) 756-4292 (international) at least 10 minutes prior to the start time and refer to conference ID 98527624. A live audio webcast of the call will be available under “Events & Presentations” in the Investor section of the Company’s website, investors.karyopharm.com/events.cfm. An archived webcast will be available on the Company’s website approximately two hours after the event.

On October 26, 2017 Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company pioneering the development of medicines to control the expression of disease-driving genes, reported that it has identified alterations in regulatory regions of the genome in immune, tumor and stromal cells isolated from pancreatic cancer patient tumors, leading to the identification of new drug targets (Press release, Syros Pharmaceuticals, OCT 26, 2017, View Source [SID1234521261]). These findings, which were made as part of a research collaboration with the Lowy laboratory at the University of California San Diego (UCSD) Moores Cancer Center, were highlighted in an oral presentation at the American College of Surgeons (ACS) 2017 Clinical Congress.

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“One of the biggest challenges in treating cancer is its ability to manipulate and evade the body’s immune response to fuel its growth,” said Andrew Lowy, M.D., Professor of Surgery and Chief of the Division of Surgical Oncology at the Moores Cancer Center. “Syros’ gene control platform provides a unique lens for understanding the regulatory mechanisms cancers use to govern cells within the tumor microenvironment. Through investigation of immune, tumor and stromal cells from patient tumors, our hope is to develop medicines that can unleash the body’s natural defenses to fight cancer.”

Together with the Lowy laboratory, Syros used its proprietary gene control platform to analyze and compare highly specialized regulatory regions of the genome, known as super-enhancers, in cells from pancreatic cancer patient tumors to those in cells from normal pancreatic tissues. Because super-enhancers control the expression of genes that determine cell function, their analysis can point to disease-driving changes in the expression of genes most critical to a given cell, as well as potential drug targets. The data presented at ACS showed that:

Leukemia inhibitory factor (LIF) gene demonstrated one of the most significant changes in enhancer size from pancreatic tumors in comparison to normal pancreatic tissue. In preclinical mouse models, LIF enhanced the anti-tumor activity of chemotherapy and produced a survival benefit when inhibited using a monoclonal antibody.
Many of the super-enhancers associated with cells in pancreatic tumor tissue are associated with genes involved in immune signaling pathways, including antigen presentation, IL10 signaling and macrophage activation, suggesting the importance of the immune system in the development and growth of pancreatic cancer and the identification of potential therapeutic targets.
Immunosuppressive tumor-associated macrophages had a distinct super-enhancer profile, pointing to genes critical for driving the immunosuppressive state and potential drug targets to reactivate immune cells. Tumor-associated macrophages are of significant interest in immuno-oncology because they play a key role in the immune response to cancer, with M1 macrophages promoting immune-mediated tumor regression and M2 macrophages promoting tumor immune evasion.
“These findings underscore the promise of Syros’ gene control platform to glean important biological insights that can lead to the identification of new drug targets and pave the way for medicines to increase killing of tumor cells by the immune system,” said Eric Olson, Ph.D., Chief Scientific Officer of Syros. “We believe our focus on analyzing the regulatory genomes of immune, tumor and stromal cells isolated from patients’ tumors represents a distinct approach to immuno-oncology with the potential to lead to novel therapies that provide a profound and durable benefit for subsets of cancer patients.”

Syros has a broader immuno-oncology drug discovery effort outside of the Lowy collaboration, which is focused on identifying and drugging novel targets to control the function of immune cells within the tumor microenvironment. Syros has identified a drug target that, when inhibited, may reduce the immunosuppressive capacity of tumor-associated macrophages and has a program based on this discovery in preclinical development. Syros’ immuno-oncology research is focused on cancers in which the tumor microenvironment is known to play a key role in disease progression, including glioblastoma and pancreatic, triple negative breast and ovarian cancers. By analyzing immune and tumor cells directly in patient tumors, Syros aims to better understand the heterogeneity of immune responses among patients and identify subsets of patients most likely to respond to specific immunotherapy strategies.