Alkermes plc Reports Third Quarter 2017 Financial Results

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.

ZIOPHARM Oncology to Host Third-Quarter 2017 Financial Results and Corporate Update Conference Call on November 6, 2017 at 4:30 p.m. ET

On October 26, 2017 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company developing new gene and cell-based immunotherapies for cancer, reported that it will host a conference call and webcast slide presentation on Monday, November 6, 2017 at 4:30 p.m. ET to provide a corporate update and discuss financial results for the third quarter ended September 30, 2017 (Press release, Ziopharm, OCT 26, 2017, View Source [SID1234521204]).

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The call can be accessed by dialing 1-844-309-0618 (U.S. and Canada) or 1-661-378-9465 (international). The passcode for the conference call is 8769629. To access the slides and live webcast or the subsequent archived recording, visit the “Investors & Media” section of the ZIOPHARM website at www.ziopharm.com. The webcast will be recorded and available for replay on the Company’s website for two weeks.

West Announces Third-Quarter 2017 Results

On October 26, 2017 West Pharmaceutical Services, Inc. (NYSE: WST) reported its financial results for the third quarter of 2017, updated financial guidance for the full-year 2017, introduced sales growth outlook for full-year 2018 and reaffirmed long-term financial targets (Press release, West Pharmaceutical Services, OCT 26, 2017, View Source [SID1234521219]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Third-Quarter 2017 Highlights

Reported net sales of $398.2 million grew 5.7% over the prior-year quarter. Net sales at constant currency (organic) grew by 3.7%.
Third-quarter 2017 reported-diluted EPS was $0.67, compared to reported-diluted EPS of $0.50 and adjusted-diluted EPS of $0.53, both in the prior-year quarter. There were no adjustments made in the third-quarter 2017.
Hurricanes in Puerto Rico had a negative impact on third-quarter 2017 sales of approximately $2 million. At current low levels of operations at both our Puerto Rican contract manufacturing facility and Biologics customers located in the area, we estimate fourth-quarter 2017 sales to be adversely impacted by approximately $5 million.
Raising full-year 2017 sales and adjusted-diluted EPS guidance. Full-year 2017 sales guidance is expected to be in a range between $1.595 billion and $1.605 billion, compared to the prior guidance range between $1.585 billion and $1.600 billion. This includes hurricane-related impacts in Puerto Rico. Full-year 2017 adjusted-diluted EPS guidance is expected to be in a range between $2.74 and $2.79, compared to the prior guidance range between $2.66 and $2.73. This includes an estimated fourth-quarter 2017 adjusted-diluted EPS negative impact of $0.03 from hurricane-related issues in Puerto Rico. Both current and prior guidance ranges include the favorable impact from tax-related benefits associated with share-based payment transactions that have been recognized during the first nine months of 2017.
Providing long-term financial objectives consistent with prior plans.
“Adjusted-diluted EPS” and “net sales at constant currency” are Non-GAAP measurements. See discussion under the heading “Non-GAAP Financial Measures” in this release.

Executive Commentary

“Our third-quarter performance was in line with our expectations,” said Eric M. Green, President and Chief Executive Officer. “We are on track to finish 2017 with strong organic sales growth led by high-value product growth in the Biologics and Generics market units.

“Looking to the future, we continue to see positive fundamentals in the markets we serve. We see unit volume growth from existing injectable drugs, future new drug approvals, and new generics and biosimilars that are entering the market. There is continued growth potential for high-value product (HVP) adoption in all our market units – Pharma, Generics and Biologics – as customers strive for higher quality and increasingly adopt zero-defect strategic imperatives. We have successfully focused our Contract-Manufactured Product segment on serving injectable medicines and diagnostic customers, and our consumer goods business continues to become a smaller part of that segment’s sales.”

Mr. Green concluded, “I am proud of our employees and their dedication to safety, quality and innovation. All of us at West are aware of the critical importance that our products play in the integrated containment and delivery of injectable medicines. I am especially proud of their response during this severe hurricane season. With a strong global team, focused on helping our customers, we are well-positioned for the future.”

Third-Quarter 2017 Financial Results (comparisons to prior-year period)

Reported net sales were $398.2 million, compared to $376.7 million. Reported net sales growth was 5.7%. On a constant-currency basis, organic sales growth was 3.7%.

Proprietary Products segment reported net sales were $308.9 million, compared to $298.1 million. Reported net sales growth was 3.6%. Organic sales growth was 1.5%, led by low-single digit growth in the Biologics and Generics market units. Biologics sales growth was lower than anticipated due to customers in Puerto Rico unable to receive shipments. Excluding this impact, Biologics organic sales growth would have been in the mid-single digit range. Generics market unit organic sales growth was positive after three consecutive quarters of declines. Pharma market unit sales declined low-single digits after a strong first-half 2017 performance.

Committed orders in the Proprietary Products segment at September 30, 2017, were $375 million, a decrease of 6% at constant currency compared to September 30, 2016.

Contract-Manufactured Products segment reported net sales were $89.3 million, compared to $79.0 million. Reported net sales growth was 13.1%, and organic sales growth was 11.5%.

Gross profit margin was 31.4%, a decrease of 70 basis points. Proprietary Products segment gross profit margin was 35.8%, a decrease of 60 basis points due to lower sales growth of high-value products, increased labor and overhead costs, partially offset by production efficiencies. Contract-Manufactured Products segment gross profit margin was 16.3%, an increase of 30 basis points due to a favorable mix of products sold and higher sales volume, partially offset by increased labor and overhead costs.

Third-quarter 2017 reported operating profit was $63.9 million, which represented an operating profit margin of 16.1%, an increase of 250 basis points from the prior-year quarter. The major driver of margin expansion was Proprietary Products other (income) expense, as the Company recognized $9.1 million of income for reimbursed costs associated with a technology that was subsequently licensed to a third party.

Income tax expense in the quarter was $14.0 million, which represented an effective tax rate of 22.3%. The effective tax rate reflects the impact of a tax benefit of $4.8 million associated with tax benefits from the adoption of guidance issued by the FASB regarding share-based payment transactions. Excluding the impact, the effective tax rate would have been approximately 30%.

Full-Year 2017 Financial Guidance

The Company is maintaining its full-year 2017 constant-currency (organic) sales growth guidance of approximately 6%.

West’s expected full-year 2017 net sales, margin and EPS guidance are as follows:

(in millions, except EPS)
2017 Updated
Guidance
Prior Guidance
Consolidated net sales
$1,595 to $1,605
$1,585 to $1,600
Consolidated gross profit margin (% of net sales)
32.6% to 32.8%
32.7% to 33.3%
Proprietary Products net sales
$1,250 to $1,255
$1,240 to $1,250
Contract-Manufactured Products net sales
$345 to $350
$345 to $350
Full-Year adjusted-diluted EPS*
$2.74 to $2.79
$2.66 to $2.73
*Includes the reported-diluted EPS impact of $0.40 for the first nine months of 2017 tax-benefit associated with the previously-discussed adoption of FASB-issued guidance. Also includes an estimated adverse impact due to severe-weather issues in Puerto Rico of approximately $5 million of net sales (and impact to consolidated gross margins) and $0.03 of adjusted-diluted EPS.
The principal currency assumption used in preparing these estimates is the translation of the euro at $1.18 for the remainder of 2017, compared to a prior assumption of $1.14 per euro.

Excluding the impact from tax benefits associated with the previously-discussed adoption of FASB-issued guidance, the Company expects that its annual effective tax rate will be approximately 30%. The Company does not plan on forecasting future benefits as they could vary quarter to quarter with the time and size of stock option exercises. Instead, the Company will include the impacts with each reported period. As a point of reference, the Company would have had $0.8 million of net income benefit in the third quarter of 2016 and would have had $18 million for the full-year 2016, resulting in an EPS benefit of $0.01 in the third-quarter 2016 and $0.24 for the full-year 2016.

The Company estimates its 2017 capital spending to be approximately $150 million.

2018 Sales Outlook and Long-Term Financial Construct

The Company expects 2018 constant-currency, organic sales growth to be in the range of 6% to 8% as a result of market volume growth and continued HVP conversions. Biologics and Generics market units are expected to return to more typical levels, with growth moderation in Contract-Manufactured Products following a strong 2017 and continued portfolio management of the consumer goods business.

The Company’s long-term financial construct remains consistent with prior plans, with 6% to 8% annual constant-currency, organic sales growth. We expect incremental sales growth from proprietary delivery systems such as SmartDose and Crystal Zenith, as their relative sales base increases over time. Favorable product mix shift, coupled with operational excellence and optimization programs, are expected to expand operating profit margins by approximately 100 basis points per year. Annual capital spending is expected to remain in a range of between $150 million and $175 million.

The Company updates and shares its high-level, long-term objectives in order to help investors, employees and other stakeholders better understand the strategic value of current and planned capital and research and development investments. As such, the revenue and profitability goals are not intended to predict or estimate actual results in any future period, but to indicate management’s view of what it believes to be achievable in that time frame.

Third-Quarter Conference Call

The Company will host a conference call to discuss the results and business expectations at 9:00 a.m. Eastern Time today. To participate on the call please dial 877-930-8295 (U.S.) or 253-336-8738 (International). The conference ID is 94093362.

A live broadcast of the conference call will be available at the Company’s website, www.westpharma.com, in the “Investors” section. Management will refer to a slide presentation during the call, which will be made available on the day of the call. To view the presentation, select “Presentations” in the “Investors” section of the Company’s website.

An online archive of the broadcast will be available at the website three hours after the live call and will be available through Thursday, November 2, 2017, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International) and entering conference ID 94093362.

Forward-Looking Statements

Certain forward-looking statements are included in this release. They use such words as “expected,” “reflects,” “continue,” “raising,” “see,” “increase,” “plan,” “will,” “estimated,” “remain,” “may,” “believes,” “expect,” “include,” “estimate,” and other similar terminology. These statements reflect management’s current expectations regarding future events and operating performance and speak only as of the date of this release. There is no certainty that actual results will be achieved in-line with current expectations. These forward-looking statements involve a number of risks and uncertainties. The following are some of the factors that could cause our actual results to differ materially from those expressed in or underlying our forward-looking statements: customers’ changing inventory requirements and manufacturing plans; customer decisions to move forward with our new products and product categories; average profitability, or mix, of the products we sell; dependence on third-party suppliers and partners; interruptions or weaknesses in our supply chain; increased raw material costs; fluctuations in currency exchange; and the ability to meet development milestones with key customers. This list of important factors is not all inclusive. For a description of certain additional factors that could cause the Company’s future results to differ from those expressed in any such forward-looking statements, see Item 1A, entitled “Risk Factors,” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016.

Except as required by law or regulation, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise.

Non-GAAP Financial Measures

This press release and the preceding discussion of the Company’s results, financial guidance, and the accompanying financial tables use the following financial measures that have not been calculated in accordance with U.S. generally accepted accounting principles (GAAP), and therefore are referred to as Non-GAAP financial measures:

Net sales at constant currency (organic sales growth)
Adjusted operating profit
Adjusted operating profit margin
Adjusted income tax expense
Adjusted net income
Adjusted diluted EPS
Net debt
Total invested capital
Net debt-to-total invested capital
The Company believes that these Non-GAAP measures of financial results provide useful information to management and investors regarding business trends, results of operations, and the Company’s overall performance and financial position. The Company’s executive management team uses these financial measures to evaluate the performance of the Company in terms of profitability and efficiency, to compare operating results to prior periods, to evaluate changes in the operating results of each segment, and to measure and allocate financial resources to its segments. The Company believes that the use of these Non-GAAP financial measures provides an additional tool for investors to use in evaluating ongoing operating results and trends in comparing its financial measures with other companies.

The Company’s executive management does not consider such Non-GAAP measures in isolation or as an alternative to such measures determined in accordance with GAAP. The principal limitation of these financial measures is that they exclude significant expenses and income that are required by GAAP to be recorded. In addition, they are subject to inherent limitations as they reflect the exercise of judgment by management about which items are excluded. In order to compensate for these limitations, Non-GAAP financial measures are presented in connection with GAAP results. The Company urges investors and potential investors to review the reconciliations of its Non-GAAP financial measures to the comparable GAAP financial measures, and not to rely on any single financial measure to evaluate the Company’s business.

Net sales at constant currency translates the current-period reported sales of subsidiaries whose functional currency is other than the U.S. dollar at the applicable foreign exchange rates in effect during the comparable prior-year period. In calculating adjusted operating profit, adjusted operating profit margin, adjusted income tax expense, adjusted net income and adjusted diluted EPS, the Company excludes the impact of items that are not considered representative of ongoing operations. Such items may include restructuring and related costs, certain asset impairments, other specifically-identified gains or losses, and discrete income tax items. A reconciliation of these adjusted Non-GAAP measures to the comparable GAAP financial measures is included in the accompanying tables.

The following is a description of the items excluded from adjusted operating profit, adjusted income tax expense, adjusted net income, and adjusted diluted EPS for the three and nine months presented in the accompanying tables:

Venezuela deconsolidation – During the nine months ended September 30, 2017, as a result of the continued deterioration of conditions in Venezuela, as well as its continued reduced access to U.S. Dollar settlement controlled by the Venezuelan government, the Company recorded a charge of $11.1 million related to the deconsolidation of its Venezuelan subsidiary, following its determination that it no longer met the GAAP criteria for control of that subsidiary. As of April 1, 2017, the Company’s consolidated financial statements exclude the results of its Venezuelan subsidiary.

Restructuring and related charges – During the three months ended September 30, 2016, the Company recorded $2.3 million in restructuring and related charges, consisting of $1.4 million for severance charges and $0.9 million for a non-cash asset write-down associated with the discontinued use of certain equipment. During the nine months ended September 30, 2016, the Company incurred $23.7 million in restructuring and related charges, consisting of $7.8 million for severance charges and $15.9 million for non-cash asset write-downs associated with the discontinued use of certain trademarks and certain equipment.

Venezuela currency devaluation – During the nine months ended September 30, 2016, the Company recorded a charge of $2.7 million related to the devaluation of the Venezuelan Bolivar from the previously-prevailing official exchange rate of 6.3 Bolivars to USD to 10.0 Bolivars to USD.

Discrete tax item – During the three and nine months ended September 30, 2016, the Company recorded a discrete tax charge of $0.3 million resulting from the impact of a change in the enacted tax rate in the United Kingdom on its previously-recorded deferred tax asset balances.

Integra LifeSciences Reports Third Quarter 2017 Financial Results

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;

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;

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.

Den 26 oktober 2017 rapporterade Xspray Pharma att de har fått godkännande för två sökta patent i USA (Press release, Xspray, OCT 26, 2017, View Source [SID1234523286]). Patentet omfattar komposition avseende produktkandidaterna HyNap-Sora och HyNap-Nilo. Det är Xsprays andra och tredje produktpatent som godkänns på huvudmarknaden i USA på kort tid. Bolaget har tidigare offentliggjort ett patentgodkännande i Japan och USA avseende HyNap-Dasa och har pågående ansökningsärenden för flera motsvarande patent i bland annat Japan och Europa.
"Nu har vi patent beviljade i USA som täcker de tre produkter vi avser att introducera på den amerikanska marknaden efter respektive original-substanspatent har löpt ut (under perioden 2020-2023). Vi har arbetar systematiskt och strategiskt med våra innovationer både för att förverkliga dem till produkter men också genom att säkra värdet med ett fullgott patentskydd. Jag ser det här som en bekräftelse på det arbetet," säger Per Andersson, vd för Xspray Pharma.

Xspray Pharma har erhållit godkännande ("notice of allowance") för två patent i USA avseende produktkandidaterna HyNap-Sora och HyNap-Nilo som är tänkta för behandling av vissa cancerformer. Det är Xsprays andra och tredje produktpatent som godkänns på den viktigaste marknaden, USA. Beskedet kommer i enlighet med bolagets plan att söka och erhålla patent för komposition och metod för samtliga tre produktkandidater under utveckling på de tre viktigaste marknaderna, USA, Europa och Japan.

"Med dessa patent, och de positiva resultaten från vår kliniska studie som vi nyligen offentliggjorde, har vi tagit viktiga steg mot målet att utveckla våra tre första produkter för lansering på den amerikanska marknaden," kommenterar Xsprays vd Per Andersson.

Xspray Pharmas aktier introducerades den 28 september på Nasdaq First North, efter en lyckosamt genomförd nyemission som tillförde bolaget 132 miljoner kronor före emissionskostnader. Planen är nu att använda kapitalet för att utveckla tre produktkandidater och blivande cancerläkemedel baserade på bolagets egenutvecklade teknologi, samt att introducera de första produkterna på den amerikanska marknaden under perioden 2020-2023.