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Acorda Provides Financial and Pipeline Update for Third Quarter 2018

On October 31, 2018 Acorda Therapeutics, Inc. (Nasdaq:ACOR) reported a financial and pipeline update for the third quarter ended September 30, 2018 (Press release, Acorda Therapeutics, OCT 31, 2018, View Source [SID1234530411]).

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"Acorda’s highest priority is preparing for the expected launch of Inbrija. Our market research indicates that healthcare professionals, patients and care partners consider OFF periods, or the re-emergence of Parkinson’s symptoms, to be one of the most significant unmet needs in Parkinson’s, and that they are enthusiastic about the prospect of an inhaled formulation of levodopa as a treatment option," said Ron Cohen, M.D., Acorda’s President and CEO.

"We were disappointed and disagree with the decision of the Federal appeals court regarding Ampyra, and we have filed an en banc petition requesting review by the entire court. At the same time, we were prepared for that potential outcome, and our original projections had us well capitalized to fully fund the launch of Inbrija and to develop the ARCUS pipeline. We have taken several steps over the past year both to conserve and to increase cash. Based on these, as well as greater than forecasted Ampyra sales, we are in now in an even stronger financial position, and are increasing our guidance for both cash and Ampyra sales in 2018."

Third Quarter 2018 Financial Results

AMPYRA (dalfampridine) Extended Release Tablets, 10 mg – For the quarter ended September 30, 2018, the Company reported AMPYRA net revenue of $137.8 million compared to $132.6 million for the same quarter in 2017.

Research and development (R&D) expenses for the quarter ended September 30, 2018 were $22.9 million, including $1.1 million of share-based compensation compared to $33.3 million, including $2.0 million of share-based compensation, for the same quarter in 2017.

Sales, general and administrative (SG&A) expenses for the quarter ended September 30, 2018 were $43.6 million, including $4.0 million of share-based compensation compared to $40.7 million, including $4.6 million of share-based compensation for the same quarter in 2017.

Provision for income taxes for the quarter ended September 30, 2018 was $38.0 million, including $3.1 million of cash taxes, compared to a provision for income taxes of $18.9 million, including $3.7 million of cash taxes, for the same quarter in 2017.

The Company reported a GAAP net loss of $(13.9) million for the quarter ended September 30, 2018, or $(0.29) per diluted share. GAAP net loss in the same quarter of 2017 was $(25.2) million, or $(0.55) per diluted share.

Non-GAAP net income for the quarter ended September 30, 2018 was $8.1 million, or $0.17 per diluted share. Non-GAAP net income in the same quarter of 2017 was $20.1 million, or $0.43 per diluted share. This quarterly non-GAAP net income measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, changes in the fair value of acquired contingent consideration, intangible asset impairment charges, and restructuring costs. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

At September 30, 2018, the Company had cash, cash equivalents and short-term investments of $460.9 million.

Guidance for 2018

AMPYRA 2018 net revenue guidance increased from $330-$350 million to more than $400 million.
R&D expenses for the full year 2018 reiterated and expected to be $100-$110 million including pre-launch manufacturing expenses associated with INBRIJA. This guidance is a non-GAAP projection that excludes share-based compensation, as more fully described below under "Non-GAAP Financial Measures."
SG&A expenses for the full year 2018 reiterated and expected to be $170-$180 million. This guidance is a non-GAAP projection that excludes share-based compensation, as more fully described below under "Non-GAAP Financial Measures."
The Company has increased projected 2018 year-end cash balance from more than $300 million to more than $400 million.
Third Quarter 2018 Highlights

INBRIJA (levodopa inhalation powder) in Parkinson’s disease
In September, the FDA extended the PDUFA goal date for its review of the New Drug Application (NDA) of INBRIJA from October 5, 2018 to January 5, 2019 based on submissions the Company made in response to requests from FDA for additional information on chemistry, manufacturing and controls (CMC). FDA determined that these submissions constituted a major amendment and will take additional time to review.
The Company reported that the inspection of its Chelsea, Massachusetts manufacturing facility and the Inbrija inhaler device manufacturer’s facility were successfully completed and closed without need for any further action by the FDA.
INBRIJA is an investigational treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen.
AMPYRA (dalfampridine)
In September, the United States Court of Appeals for the Federal Circuit, by a 2-1 vote, upheld the United States District Court for the District of Delaware’s decision to invalidate four Ampyra patents.
In October, the Company filed a petition for en banc hearing with the United States Court of Appeals for the Federal Circuit.
The Company announced that it had settled with Mylan AG to market an authorized generic version of Ampyra. In mid-September, Mylan announced the U.S. launch of the authorized generic.
Webcast and Conference Call

The Company will host a conference call today at 8:30 a.m. ET. To participate in the conference call, please dial (833) 236-2756 (domestic) or (647) 689-4181 (international) and reference the access code 4468928. The presentation will be available on the Investors section of www.acorda.com. A replay of the call will be available from 11:30 a.m. ET on October 31, 2018 until 11:59 p.m. ET on November 30, 2018. To access the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642 (international); reference code 4468928. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

Epigenomics AG Announces Veterans Administration’s Adherence Study using Epi proColon® Colorectal Cancer Screening Blood Test

On October 31, 2018 Epigenomics AG (FSE: ECX, OTCQX: EPGNY) reported the Veterans Administration New York Harbor Healthcare System (VA-Manhattan) is commencing a study to assess the adherence impact of offering a blood-based colorectal cancer screening test and colonoscopy completion in patients who have refused colonoscopy and fecal immunochemical test (FIT) (Press release, Epigenomics, OCT 31, 2018, View Source [SID1234530405]).

The VA-Manhattan has received grants from the American Society for Gastrointestinal Endoscopy (ASGE) and New York Society for Gastrointestinal Endoscopy (NYSGE) to assist in the performance of this study. The study will be managed through The Narrows Institute. Epigenomics will provide testing and budgetary support for testing.

Colorectal cancer (CRC) is the fourth most common cancer and the second deadliest cancer in the US. However, CRC is a preventable condition with screening being one of the most impactful public health contributions to prevention. Screening rates are suboptimal due to patient barriers to colonoscopy or stool-based testing. Unscreened patients contribute to approximately 43% of new CRC cases, 70% of CRC deaths, and 76% of CRC treatment expenditures.

The goal of the VA-Manhattan study is to assess the potential of a blood-based test as an acceptable alternative for these screen-resistant individuals. If the proposed study shows high acceptance of the blood test as well as reliable colonoscopy follow up for positive tests, then the blood test could play an important adjunctive role in improving overall screening rates.

"Some people simply don’t want colonoscopy or stool-based colorectal cancer screening, so we need to understand how effective alternative methods such as a blood-based test are at engaging these individuals," said Dr. Peter Liang, the study principal investigator and a gastroenterologist at the VA-Manhattan.

"Unscreened patients contribute significantly to new CRC cases, deaths, and treatment costs," said Greg Hamilton, CEO of Epigenomics AG. "Addressing the unscreened challenge with a blood test could unquestionably have an impact to colorectal cancer management. We look forward to the study outcomes as they have the potential to support the use of a blood test on screening-resistant patients."

Gilead Sciences and Tango Therapeutics Announce Strategic Collaboration to Develop Next-Generation Targeted Immuno-Oncology Therapies

On October 31, 2018 Gilead Sciences, Inc. (Nasdaq: GILD) and Tango Therapeutics, Inc., a company focused on the discovery and development of novel cancer therapies, reported a global strategic collaboration to discover, develop and commercialize a pipeline of innovative targeted immuno-oncology treatments for patients with cancer (Press release, Gilead Sciences, OCT 31, 2018, View Source;p=irol-newsArticle&ID=2374439 [SID1234530402]).

Under the multi-year collaboration, Tango will perform target discovery and validation and Gilead will have options to worldwide rights on up to five targets emerging from Tango’s proprietary functional genomics-based discovery platform. For two programs directed to these targets, Tango will retain the option to co-develop and co-detail in the U.S. The collaboration does not include Tango’s lead programs, for which Tango will retain all rights.

"Tango has built a unique discovery platform that we hope will help create the next generation of cancer therapies," said John McHutchison, AO, MD, Gilead’s Chief Scientific Officer and Head of R&D. "Our collaboration will combine Tango’s innovative discovery technology alongside Gilead’s drug discovery and development capabilities to build a pipeline of novel immuno-oncology therapies."

"Gilead is the ideal partner to help us bring potentially transformative treatments to patients with cancer," said Barbara Weber, MD, Tango’s President and Chief Executive Officer. "This partnership has significant strategic value for us. With Gilead as our partner, we can maximize the applications of our platform in immuno-oncology, while continuing to independently advance our lead programs into the clinic and beyond."

Under the terms of the agreement, Tango will receive an upfront payment of $50 million. Tango will also be eligible to receive approximately $1.7 billion in total additional payments across all programs in the form of pre-clinical fees and development, regulatory and commercial milestone payments; and up to low double-digit tiered royalties on net sales. For those programs that Tango opts in to co-develop and co-detail, the parties will split profits and losses 50/50 for the U.S., development costs will be shared in a manner that is commensurate with product rights, and Tango will be eligible to receive milestone payments and royalties on ex-U.S. sales.

CohBar to Announce 2018 Third Quarter Financial Results and Host Conference Call on November 14, 2018

On October 31, 2018 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics (MBTs) to treat age-related diseases, reported that it will release its third quarter 2018 financial results after the market closes on Wednesday, November 14, 2018, followed by a conference call on which the company’s management will discuss the results and provide a company update (Press release, CohBar, OCT 31, 2018, View Source [SID1234530401]).

Details for the Conference Call:

Date: November 14, 2018
Time: 2:00 p.m. (Pacific Time)

Conference Audio

Dial-in U.S. and Canada: (888) 394-8218
Dial-in International: (323) 701-0225
Conference ID No.: 1659879
We kindly request that you call into the conference audio approximately 10 minutes before the start time so that we can begin promptly.

An audio replay of the call will be available beginning at 5:00 p.m. Pacific Time on November 14, 2018, through 9:00 p.m. Pacific Time on December 5, 2018. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID No. 1659879. The audio replay will also be available at www.cohbar.com from November 14, through December 5, 2018.

Integra LifeSciences Reports Third Quarter 2018 Financial Results

On October 31, 2018 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported financial results for the third quarter ending September 30, 2018 (Press release, Integra LifeSciences, OCT 31, 2018, View Source [SID1234530398]).
Third Quarter 2018 Consolidated Results

Reported revenue was $365.9 million, an increase of 31.2% compared to the third quarter of 2017 with the acquisition of Codman contributing $78.9 million, and organic revenues increased 6.2% over the third quarter of 2017;

GAAP earnings per share was $0.15, compared to $0.04 in the third quarter of 2017;

Adjusted earnings per share was $0.59, reflecting an increase of 31.1% compared to the third quarter of 2017;

The company is revising its full-year 2018 guidance as follows:

Total revenue is now expected to be a range of $1.467 billion to $1.472 billion (previously $1.475 billion to $1.490 billion);

Guidance range reflects lower forecasted revenue from extremities orthopedics, Codman revenue in select countries outside the U.S. where commercial operations have not yet transferred to Integra ("Day 2 Countries"), and a lower foreign currency benefit;

Organic revenue growth guidance is now expected to be approximately 4% (previously approximately 5%);

The company is reiterating its full-year 2018 GAAP earnings per share of $0.71 to $0.77 and adjusted earnings per share of $2.36 to $2.42.

Total revenues for the third quarter of 2018 were $365.9 million, reflecting an increase of 31.2% over the third quarter of 2017. Sales in the Codman Specialty Surgical segment increased 45.1% compared to the third quarter of 2017, driven by the Codman acquisition and strong performance in the Dural Access and Repair, Advanced Energy, and Neuro Monitoring businesses. Sales in the Orthopedics and Tissue Technologies segment increased 11.2%, reflecting continued strength in our Regenerative Technologies and Private Label businesses.
Total organic revenues increased 6.2% over the third quarter of 2017, excluding acquisitions, divestitures and the effect of currency exchange rates.
"Despite some revenue softness in the second half of the year, we continue to make solid progress with the Codman integration and the channel expansion efforts, particularly in Regenerative Technologies," said Peter Arduini, Integra’s president and chief executive officer. "We remain confident that 2019 organic sales will grow within our targeted long-term range of 5% to 7% and accelerate from our full-year 2018 results."
The company reported GAAP net income of $13.3 million, or $0.15 per diluted share, for the third quarter of 2018, compared to GAAP net income of $3.2 million, or $0.04 per diluted share, in the third quarter of 2017. The increase in GAAP net income is a result of higher revenues, better operating expense leverage and a lower tax rate.
The adjusted measures discussed below are computed with the adjustments to GAAP reporting that are set forth in the attached reconciliation.
Adjusted EBITDA for the third quarter of 2018 was $84.3 million, or 23.0% of revenue, compared to $63.0 million, or 22.6% of revenue, in the third quarter of 2017. The margin improvement was largely based on better operating expense leverage, mostly from selling, general and administrative costs.
Adjusted net income for the third quarter of 2018 was $50.6 million, an increase of 40.2% from the prior year’s third quarter. Adjusted earnings per share for the third quarter of 2018 was $0.59, an increase of 31.1% over the prior year’s quarter.
2018 Full-Year Outlook
The company is revising its full-year 2018 total revenue guidance to a new range of $1.467 billion to $1.472 billion. This includes an expectation for organic growth of approximately 4% for the full year 2018 versus the previous guidance of approximately 5%.
The company is reiterating its full-year 2018 GAAP earnings per share guidance range of $0.71 to $0.77, and adjusted earnings per share guidance range of $2.36 to $2.42.

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, Wednesday, October 31, 2018, 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 (334) 323-0522 and using the passcode 3216000. The call can also be accessed via a webcast link provided on investor.integralife.com. A replay of the call will be available through November 5, 2018 by dialing (719) 457-0820 and using the passcode 3216000. The webcast will also be archived on the website.