On February 27, 2018 Ophthotech Corporation (Nasdaq:OPHT) reported financial and operating results for the fourth quarter and full year ended December 31, 2017 and provided a business update (Press release, Ophthotech, FEB 27, 2018, View Source [SID1234524253]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The Company also announced today that it has initiated an innovative gene therapy program focused on applying novel gene therapy technology to discover and develop new therapies for ocular diseases. The Company intends to investigate promising gene therapy product candidates and other technologies through collaborations with leading companies and academic institutions in the United States and internationally. For its first gene therapy collaboration, the Company has entered into a series of sponsored research agreements with the University of Massachusetts Medical School (UMMS) and its Horae Gene Therapy Center to utilize their "minigene" therapy approach and other novel gene delivery technologies to target retinal diseases. As a condition of each research agreement, UMMS has granted the Company an option to obtain an exclusive license to any patent or patent applications that result from this research. This announcement will be discussed during today’s conference call/webcast (see press release issued earlier today and call in details below).

"In 2017, our team began to execute on a strategic plan to restructure the Company, broaden our Zimura portfolio to include development programs in both orphan diseases and larger indications in the back of the eye, including dry and wet forms of age-related macular degeneration, and to initiate an aggressive business development outreach," stated Glenn P. Sblendorio, Chief Executive Officer and President of Ophthotech. "We start 2018 with a strong balance sheet, multiple clinical trials in our Zimura program, and have now entered into the gene therapy arena with a collaboration with the Horae Gene Therapy Center at University of Massachusetts Medical School. Looking ahead we will continue to seek collaborations, in-licensing and partnering opportunities that offer novel and differentiating approaches, including gene therapy approaches, for treating diseases of the eye."

Zimura Complement Factor C5 Inhibitor Program

During the second half of 2017, the Company modified its on-going Zimura (avacincaptad pegol) clinical trial for the treatment of geographic atrophy (GA) secondary to dry age related macular degeneration (AMD). The modification of the trial design accelerates the anticipated timeline for obtaining top-line data. Initial top-line data is expected to be available during the second half of 2019. The scientific details of the GA secondary to dry AMD clinical trial were presented at the 41st Annual Macula Society Meeting in Beverly Hills, California, February 21-24, 2018.
During the third quarter of 2017, the Company initiated a dose-ranging, open-label Phase 2a clinical trial of Zimura in combination with the anti-vascular endothelial growth factor (anti-VEGF) agent Lucentis (ranibizumab) in patients with wet AMD who have not been previously treated with any anti-VEGF agents. Based on the current enrollment rate, the Company expects initial top-line data from this trial to be available by the end of 2018.
In January 2018, the first patient was enrolled in the Company’s Phase 2b randomized, double-masked, sham-controlled clinical trial assessing the efficacy and safety of Zimura in patients with autosomal recessive Stargardt disease (STGD1). Initial top-line data is expected to be available in 2020. The scientific details of the Stargardt clinical trial will be presented at the 2018 Annual Meeting of the Association for Research in Vision and Ophthalmology in Honolulu, Hawaii, April 29 – May 3, 2018 and at The International Symposium on Ocular Pharmacology and Therapeutics in Tel-Aviv, Israel, March 1-3, 2018.
During the fourth quarter of 2017, the Company initiated an open-label Phase 2a clinical trial evaluating Zimura in combination with the anti-VEGF agent Eylea (aflibercept) for the treatment of idiopathic polypoidal choroidal vasculopathy in treatment experienced patients. Initial top-line data is expected to be available during the second half of 2019.

In January 2018, the Company announced the election of Jane PritchettHenderson, Chief Financial Officer and Senior Vice President of Corporate Development at Voyager Therapeutics, to its Board of Directors. Ms. Henderson has also been elected the Chair of the Ophthotech Audit Committee.

2018 Operational Update

As of December 31, 2017, the Company had $167 million in cash and cash equivalents. Based on the Company’s current 2018 business plan, including continuation of its development programs for Zimura and initiation of its collaborative gene therapy research programs, the Company expects the cash required to fund its operations and capital expenditures for 2018 will range between $50 million and $55 million. This estimate does not reflect any additional expenditures resulting from the potential in-licensing or acquisition of additional product candidates or technologies or associated development that the Company may pursue.

Fourth Quarter 2017 Financial Highlights

Revenues: Collaboration revenue was $0 for the quarter ended December 31, 2017, compared to $5.3 million for the same period in 2016. For the year ended December 31, 2017, collaboration revenue was $210.0 million, compared to $50.9 million for 2016. Collaboration revenue variances for both the quarter and the year are the result of the completion of deliverables under the Fovista licensing and commercialization agreement with Novartis Pharma AG and the recognition of all associated deferred revenue during the third quarter of 2017. The recognition of this revenue did not impact the Company’s cash balance.
R&D Expenses: Research and development expenses were $7.9 million for the quarter ended December 31, 2017, compared to $59.4 million for the same period in 2016. For the quarter ended December 31, 2017, research and development expenses included approximately $0.7 million in costs related to the Company’s previously announced reduction in personnel. For the year ended December 31, 2017, research and development expenses were $66.3 million, compared to $196.3 million for 2016. For the year ended December 31, 2017, research and development expenses included approximately $7.5 million in costs related to the Company’s previously announced reduction in personnel. Research and development expenses decreased in both the quarter and year ended December 31, 2017 primarily due to its termination of the Fovista development programs in wet AMD.

G&A Expenses: General and administrative expenses were $6.9 million for the quarter ended December 31, 2017, compared to $13.0 million for the same period in 2016. For the quarter ended December 31, 2017, general and administrative expenses included approximately $0.5 million in costs related to the Company’s previously announced reduction in personnel. For the year ended December 31, 2017, general and administrative expenses were $35.7 million, compared to $50.2 million in 2016. For the year ended December 31, 2017, general and administrative expenses included approximately $5.6 million in costs related to the Company’s previously announced reduction in personnel and its termination of facilities leases. General and administrative expenses decreased in both the quarter and year ended December 31, 2017 primarily due to a decrease in personnel and infrastructure costs to support the Company’s operations.
Net Income: The Company reported a net loss for the quarter ended December 31, 2017 of $9.5 million, or ($0.26) per diluted share, compared to a net loss of $66.3 million, or ($1.86) per diluted share, for the same period in 2016. For the year ended December 31, 2017, the Company reported net income of $114.2 million, or $3.17 per diluted share, compared to a net loss of $193.4 million, or ($5.45) per diluted share, for 2016.

Conference Call/Web Cast Information

Ophthotech will host a conference call/webcast to discuss the Company’s financial and operating results and provide a business update. The call is scheduled for February 27, 2018 at 8:00 a.m. Eastern Time. To participate in this conference call, dial 800-239-9838 (USA) or 323-794-2551 (International), passcode 9171013. A live, listen-only audio webcast of the conference call can be accessed on the Investor Relations section of the Ophthotech website at: www.ophthotech.com. A replay will be available approximately two hours following the live call for two weeks. The replay number is 888-203-1112 (USA Toll Free), passcode 9171013.

On February 27, 2018 LabCorp presents Investor’s Day Presentation (Presentation, LabCorp, FEB 27, 2018, View Source [SID1234524251]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

On February 27, 2018 Integra LifeSciences Holdings Corporation (NASDAQ:IART) today reported financial results for the fourth quarter and full-year ended December 31, 2017 (Press release, IsoTis, FEB 27, 2018, View Source [SID1234524240]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Highlights:

The Company completed the acquisition of Codman Neurosurgery, the largest in its history, on October 2, 2017;

Reported revenue for the full-year 2017 was $1,188.2 million, an increase of 19.8%, or $196.2 million over the prior year; acquisitions contributed $162.1 million to the full year, while organic sales were higher by 4.6% over the prior year;

Fourth quarter revenue was $368.6 million, an increase of 44.2%, or $112.9 million over the prior year quarter; acquisitions contributed $103.3 million to the fourth quarter, while organic sales were higher by 5.8% over the prior year quarter;

Fourth quarter GAAP earnings per diluted share amounted to $0.56, a 60% increase over the prior year period, and includes a net tax benefit of $37.9 million, or $0.47 per diluted share, associated with the U.S. Tax Cuts and Jobs Act;

Fourth quarter adjusted earnings per diluted share amounted to $0.64, a 23% increase over the prior year period;

Full-year 2017 GAAP earnings per diluted share amounted to $0.82, a 12.8% decrease over the prior year; Full-year adjusted earnings per diluted share amounted to $1.94, a 10.2% increase over the prior year, which represents the fourth consecutive year of double-digit adjusted earnings per diluted share growth; and

The Company now expects to be at the high-end of its previously provided full-year 2018 revenue guidance range of $1.46 billion to $1.48 billion, largely due to favorable foreign currency exchange rates. The Company expects full-year GAAP earnings per diluted share to be in a range of $0.60 to $0.70, and also expects full-year adjusted earnings per diluted share to be at the high-end of its previously provided range of $2.25 to $2.35, due to a lower expected tax rate associated with the U.S. Tax Cuts and Jobs Act.

Total revenues for the full year 2017 were $1,188.2 million, an increase of $196.2 million, or 19.8%, over the prior year. Total revenues for the fourth quarter were $368.6 million, an increase of $112.9 million, or 44.2%, over the fourth quarter of 2016.

Organic revenues for the full year 2017, as set forth in the attached reconciliation, increased 4.6% over the prior year, while fourth quarter organic revenues were higher by 5.8% over the fourth quarter of 2016.

"2017 was a transformative year for Integra. We closed the two largest acquisitions in the Company’s history, expanded our regenerative portfolio with new, innovative products and successfully executed the global launch of CUSA Clarity, a significant upgrade to our tissue ablation platform," said Peter Arduini, Integra’s President and Chief Executive Officer. "We look forward to 2018 and another year of strong revenue growth, margin expansion and improving profitability."

The Company reported GAAP net income of $64.7 million, or $0.82 per diluted share, for the full year 2017, compared to GAAP net income of $74.6 million, or $0.94 per diluted share, in 2016.

The Company reported GAAP net income of $44.4 million, or $0.56 per diluted share, in the fourth quarter of 2017, compared to GAAP net income of $28.2 million, or $0.35 per diluted share, in the fourth quarter of 2016.

In 2017, the U.S. Tax Cuts and Jobs Act resulted in the Company recognizing a net income tax benefit of $37.9 million. This includes a $43.4 million benefit from the re-measurement of deferred taxes as a result of the reduction in U.S. corporate tax rates from 35% to 21%, offset by a one-time toll charge of $5.5 million imposed on deemed repatriation of foreign untaxed earnings.

Adjusted measures discussed below are computed with the adjustments to GAAP reporting set forth in the attached reconciliation.

Adjusted EBITDA for the full year 2017 was $269.5 million, an increase of $37.8 million, over the prior year. For the full year 2017, adjusted EBITDA as a percentage of revenue declined from 23.4% in 2016 to 22.7% in 2017, largely resulting from the dilution of the Derma Sciences acquisition and higher sales channel investments.

Adjusted EBITDA for the fourth quarter of 2017 was $88.7 million, an increase from $66.5 million in the fourth quarter of the prior year. For the fourth quarter of 2017, adjusted EBITDA as a percentage of revenue was 24.1%, compared to 26.0% in the prior year period.

Adjusted net income for the full year 2017 was $153.4 million, or $1.94 per diluted share, compared to $135.3 million, or $1.76 per diluted share, in 2016. Adjusted net income for the fourth quarter of 2017 was $51.0 million, or $0.64 per diluted share, compared to adjusted net income of $40.7 million, or $0.52 per diluted share, in the fourth quarter of 2016.

For the year ended December 31, 2017, cash flows from operations totaled $114.5 million. Capital expenditures were $43.5 million. Adjusted free cash flow conversion for the trailing twelve months ended December 31, 2017 was 46.3% versus 82.7% for the twelve months ended December 31, 2016, due to significant one-time cash outlays associated with the acquisition integrations. In the fourth quarter of 2017, the Company generated $11.6 million of cash flows from operations, and incurred capital expenditures of $13.7 million.

Outlook for 2018

The Company is reiterating its full-year 2018 revenue guidance in the range of $1.46 billion to $1.48 billion, and now expects to be at the high end of the range due primarily to more favorable foreign currency rates.

The Company expects GAAP earnings per diluted share for the full year to be between $0.60 and $0.70, and adjusted earnings per diluted share to be at the high end of its previously provided range of $2.25 to 2.35, due primarily to a lower expected tax rate from the U.S. Tax Cuts and Jobs Act.

"Given our strong close to the year, the momentum in our businesses, and the benefit of a lower tax rate, we remain confident that we will deliver 5% organic growth and adjusted earnings per share at the high-end of our range," said Glenn Coleman, Chief Financial Officer. "Consistent with previous guidance, we expect first quarter organic growth to be in the low single-digits as we work through the sales channel integration in both of our segments, which we believe will result in higher organic growth in the second half of 2018."

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 that it will exclude in the calculation of organic revenue growth, adjusted EBITDA and adjusted EPS for historical periods and in providing adjusted EPS guidance.

Conference Call and Presentation Available Online

Integra has scheduled a conference call for 8:30 a.m. ET today, Tuesday, February 27, 2018 to discuss fourth quarter and full-year 2017 financial results, 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.

On February 27, 2018 FibroGen, Inc. (NASDAQ:FGEN), a science-based biopharmaceutical company, reported financial results for the fourth quarter and full year 2017 and provided an update on the company’s recent developments (Press release, FibroGen, FEB 27, 2018, View Source;p=RssLanding&cat=news&id=2335086 [SID1234524229]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"In 2017, we continued to make significant progress on key clinical and regulatory milestones. Our first NDA submission for roxadustat was accepted for review by the China Food and Drug Administration. With our partners, we are advancing the roxadustat Phase 3 CKD anemia programs to completion with plans to file for market approvals in the U.S., Europe, and Japan. In our fibrosis program, pamrevlumab has demonstrated tremendous potential in multiple indications. In a randomized double-blind, placebo-controlled Phase 2b study in IPF, pamrevlumab was well-tolerated and achieved statistical significance in the primary endpoint of FVC % predicted, in FVC, and in the secondary endpoints of quantitative changes of lung fibrosis, disease progression, and patient-reported outcomes," said Thomas B. Neff, FibroGen’s Chief Executive Officer. "We are intensely focused on the execution of critical activities for our CKD anemia, idiopathic pulmonary fibrosis, and pancreatic cancer programs as these approach important new milestones in 2018."

Recent Developments and Highlights
Roxadustat for CKD Anemia in U.S./ROW

With our partner AstraZeneca, we have agreed to a timeline for Phase 3 enrollment completion in the second quarter of 2018 and data readout in the fourth quarter of 2018 to support U.S. regulatory submission in the first half of 2019
DSMB recommended Phase 3 clinical studies to continue under current protocols with no changes

Roxadustat for CKD Anemia in China

Positive efficacy and safety results reported from two Phase 3 trials
New Drug Application accepted for filing by the CFDA

Roxadustat for CKD Anemia in Japan

Our partner Astellas has completed three of six Phase 3 trials
Topline positive Phase 3 results reported in peritoneal dialysis study

Roxadustat for MDS Anemia

Enrollment commenced in our first U.S./Europe Phase 3 study for the treatment of anemia in myelodysplastic syndromes (MDS)

Pamrevlumab for Idiopathic Pulmonary Fibrosis (IPF)

Statistically significant high-resolution computed tomography (HRCT) results achieved in our randomized double-blind, placebo-controlled Phase 2b study
Positive Phase 2b study results presented at European Respiratory Society (ERS) International Congress 2017

Pamrevlumab for Pancreatic Cancer

Reported positive interim Phase 2 open-label results at 2017 ASCO (Free ASCO Whitepaper)-GI conference showing a majority of pamrevlumab-treated patients converted from unresectable to resectable cancer; all resection evaluations complete and results continue to be favorable for pamrevlumab

Corporate and Financial

Net loss for the fourth quarter of 2017 was $22.1 million, or $0.27 per share, compared to $34.0 million, or $0.54 per share one year ago
Net loss for the year ended December 31, 2017, was $126.2 million, or $1.73 per share, compared to $61.7 million, or $0.98 per share one year ago
At December 31, 2017, FibroGen had $762.2 million in cash, restricted time deposits, cash equivalents, investments, and receivables
Received a $15.0 million milestone payment from AstraZeneca in the fourth quarter of 2017 upon roxadustat NDA submission to CFDA
Completed financings in April 2017 and in August 2017 with net proceeds of $115.1 million and $356.2 million, respectively

2018 Outlook

U.S. Phase 3 CKD anemia enrollment completion in the second quarter of 2018
U.S. Phase 3 CKD anemia data readout in the fourth quarter of 2018 to support U.S. regulatory submission in the first half of 2019
NDA approval decision expected in China for CKD anemia by the end of 2018
Expect to confirm plans with our partner Astellas for regulatory submissions in Europe and Japan
Anticipate data readout from two Japan Phase 3 hemodialysis studies, a long-term conversion study and a correction (ESA-naïve) study, in the first quarter of 2018
Anticipate initiation of roxadustat Phase 2/3 clinical study in China for anemia associated with MDS in first half of 2018
Expect to present HRCT and health-related quality-of-life results from the IPF Phase 2b trial at an upcoming scientific conference
Design pivotal trials for IPF and locally advanced pancreatic cancer

Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, February 27, 2018, at 5:00 p.m. Eastern (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the company’s website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (888) 771-4371 (U.S. and Canada) or 1 (847) 585-4405 (international), reference the FibroGen fourth quarter and full year 2017 financial results conference call, and use passcode 46307822#. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (888) 843-7419 (domestic) or (630) 652-3042 (international), and use passcode 46307822#.

On February 27, 2018 Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that the Company will host a conference call and live audio webcast on Monday, March 5, 2018 at 5:00 p.m. ET to report its fourth quarter and full year 2017 financial results and provide a corporate update (Press release, Fate Therapeutics, FEB 27, 2018, http://ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-webcast-conference-call-reporting-fourth-3 [SID1234524228]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

In order to participate in the conference call, please dial 877-303-6235 (domestic) or 631-291-4837 (international) and refer to conference ID 7589759. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.