Aclaris Therapeutics to Webcast Conference Call Discussing Fourth Quarter and Full Year 2017 Financial Results on March 12, 2018

On February 28, 2018 Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company focused on identifying, developing, and commercializing innovative and differentiated therapies to address significant unmet needs in medical and aesthetic dermatology, reported that it will report financial results for the fourth quarter and year ending December 31, 2017 on Monday, March 12, 2018, before the U.S. financial markets open (Press release, Aclaris Therapeutics, FEB 28, 2018, https://aclaristherapeuticsinc.gcs-web.com/news-releases/news-release-details/aclaris-therapeutics-webcast-conference-call-discussing-fourth [SID1234524219]).

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!

Management will provide an update on the Company and discuss fourth quarter and year-end 2017 results as well as expectations for the future via conference call on Monday, March 12, 2018, at 8:00 AM ET. To participate on the live call, please dial (844) 776-7782 (domestic) or (661) 378-9535 (international), and reference conference ID 1495576 prior to the start of the call.

A live webcast of the event can be accessed on the Events and Presentations page on the Investors section of the Aclaris website at View Source A replay of the webcast will be archived on the Aclaris website following the event.

Heat Biologics Announces Positive Interim Data from its Phase 2 Clinical Trial of HS-110 and Nivolumab in Non-Small Cell Lung Cancer (NSCLC)

On February 28, 2018 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer, reported interim results from its Phase 2 study investigating HS-110 in combination with Bristol-Myers Squibb’s (Press release, Heat Biologics, FEB 28, 2018, View Source [SID1234524236]).

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!

anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo), in patients with advanced non-small cell lung cancer (NSCLC) whose cancers have progressed after treatment with one or more lines of therapy.

Among the 35 patients in the Intent-to-Treat ("ITT") population, 6 patients (17%) achieved a partial response and 14 patients (40%) achieved disease control. Evaluable ITT patients (those who underwent at least one follow-up scan regardless of treatment duration) demonstrated overall response and disease control rates of 26% and 67%, respectively. Overall responses appeared durable and long lasting. The survival data are still maturing, and median overall survival has not yet been reached. The combination of HS-110 and nivolumab was well tolerated, with no additional toxicities compared to what has been observed with single agent checkpoint inhibitors.

As predefined in the clinical protocol, patient subgroups were evaluated for levels of tumor infiltrating lymphocytes ("TIL") and for PD-L1 checkpoint protein expression on tumor cells. Four of 9 "cold tumor" patients with low TIL levels (<10%) at baseline had partial responses. HS-110 also showed a durable effect in patients with low levels of PD-L1, with 3 of 9 patients responding. Both of these patient populations respond poorly to checkpoint inhibitors.

George Peoples, M.D., Chief Medical Officer, stated, "The results from this combination trial with HS-110 and nivolumab are very promising, demonstrating durable responses in those patients with low levels of TIL and PD-L1. These patients represent the most difficult-to-treat patient groups and comprise the majority of the NSCLC population."

"We look forward to continuing patient enrollment to better define the optimal NSCLC population and inform the design of a pivotal trial," commented Jeff Wolf, Chairman and CEO. "These data are consistent with the mechanism of action of our T-cell Activation Platform that promotes a robust T-cell immune response, an important component of an effective immunotherapy combination against cancer."

DURGA Trial Design

The ongoing DURGA trial is a single arm multicenter trial that was designed to evaluate the combination of HS-110 and nivolumab in patients with NSCLC. Patients with advanced and previously treated NSCLC were treated with weekly HS-110 for 18 weeks and nivolumab 3 mg/kg every 2 weeks until disease progression or death. The primary endpoints are 1) safety and tolerability, and 2) objective response rate as defined by RECIST 1.1 criteria. Secondary endpoints include disease control rate, duration of response, peripheral blood immune response, progression-free survival and overall survival.

Live Webcast with Slides

The interim data from the DURGA trial will be presented at an analyst event, taking place at 8am Eastern Time, today, Wednesday February 28th. To register and watch a live webcast of the event, visit View Source

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

AMAG Pharmaceuticals has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, AMAG Pharmaceuticals, 2018, FEB 28, 2018, View Source [SID1234524274]).

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!

Allergan to Present at The Barclays Global Healthcare Conference

On February 28, 2018 Allergan plc (NYSE: AGN), a leading global biopharmaceutical company, reported that Chairman and CEO Brent Saunders will present at the Barclays Global Healthcare Conference in Miami, FL (Press release, Allergan, FEB 28, 2018, View Source(1) [SID1234524221]). The presentation will begin at 1:35 p.m. Eastern Time on Wednesday, March 14, 2018.

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 presentation will be webcast live and can be accessed on Allergan’s Investor Relations website at www.allergan.com/investors. The webcast can also be accessed through the following URL: https://cc.talkpoint.com/barc0…

An archived version will be available within approximately 4 hours of the live presentation, and can be accessed at the same location for 180 days.

Valeant Announces Fourth-Quarter And Full-Year 2017 Results And Provides 2018 Guidance

On February 28, 2018 Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) ("Valeant" or the "Company" or "we") reported its fourth-quarter and full-year 2017 financial results (Press release, Valeant, FEB 28, 2018, http://ir.valeant.com/news-releases/2018/02-28-2018-120240355 [SID1234524266]).

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!

"2017 was a year of strong progress for Valeant as we delivered organic growth2 across nearly 75 percent of the Company while significantly reducing our debt and investing in our Bausch + Lomb, Salix and Ortho Dermatologics businesses," said Joseph C. Papa, chairman and CEO, Valeant.

"Since the end of the first quarter of 2016, we’ve reduced our total debt by more than 20 percent, and we will continue to address our debt, as well as reduce expenses. Additionally, we’re committed to growth through strategic investment in our core businesses, key products and late-stage pipeline. Altogether, these will get us to the final phase of our strategic plan – the transformation of Valeant," Mr. Papa continued.

Company Highlights

Executing on Core Businesses

The Bausch + Lomb/International segment comprised approximately 56% of the Company’s revenue in 2017
Reported revenue decreased by 1% compared to 2016; excluding foreign exchange and divestitures, revenue grew organically2 by 6% compared to 2016
Generated mid-single digit organic growth2 during each of the four quarters of 2017
The Salix business, which is reported within the Branded Rx segment, comprised approximately 18% of the Company’s revenue in 2017
Reported revenue grew by 2% and revenue grew organically2 by 5%, compared to 2016
Generated mid-single digit or higher organic growth2 during the second, third and fourth quarters of 2017
Continued to focus on stabilizing the dermatology business, which is reported within the Branded Rx segment
Recruited new leadership team and rebranded the business as Ortho Dermatologics
Increased dermatology sales force by more than 25% in January 2018

Launching New Products and Advancing Pipeline

Launched more than 100 new products globally in 2017
Launched AQUALOX contact lenses in Japan
Introduced Biotrue ONEday for Astigmatism daily disposable contact lenses in 20 countries in Europe
Received CE Mark from the European Commission for the Stellaris Elite Vision Enhancement system, including Vitesse
Received approval from the U.S. Food and Drug Administration (FDA) for and launched VYZULTA, a treatment option for glaucoma
Received FDA approval for SILIQ and launched it as the lowest-priced injectable biologic for moderate-to-severe plaque psoriasis in the United States based on total annual cost
Received FDA approval for LUMIFY, the only over-the-counter eye drop with low-dose brimonidine for the treatment of eye redness
Obtained 510(k) clearances from the FDA for Thermage FLX System, Stellaris Elite Vision Enhancement System and Vitesse
The FDA accepted New Drug Applications for:
DUOBRII3 (IDP-118), a topical treatment for plaque psoriasis; PDUFA action date of June 18, 2018
ALTRENO3 (IDP-121), an acne treatment in lotion form; PDUFA action date of Aug. 27, 2018
JEMDEL3 (IDP-122), a topical treatment for plaque psoriasis; PDUFA action date of Oct. 5, 2018

Reducing Debt, Extending Maturities and Resolving Legacy Issues

As of Feb. 28, 2018, reduced total debt by more than $6.7 billion since the end of the first quarter of 2016
Reduced total debt by more than $4.4 billion in 2017
Exceeded $5 billion commitment to pay down debt from divestiture proceeds and free cash flow earlier than the previously stated timing of February 2018
Reduced debt repayment requirements through 2020 by more than $10.8 billion since Dec. 31, 2016; eliminated all long-term debt maturities until 2020 and all mandatory amortization requirements
Completed 13 divestitures since the beginning of 2016, including skin care brands (CeraVe, AcneFree and AMBI), Dendreon Pharmaceuticals, iNova Pharmaceuticals, Obagi Medical Products and Sprout Pharmaceuticals
Achieved dismissals or other positive outcomes in resolving and managing litigation and investigations in more than 80 historical matters since the beginning of 2017
Agreed to resolve the Allergan securities litigation, subject to court approval
Agreed to resolve the SOLODYN antitrust litigations in February 2018, with the class settlement ($58 million) being subject to court approval

Fourth-Quarter and Full-Year Revenue Performance
Total revenues were $2.163 billion for the fourth quarter of 2017, as compared to $2.403 billion in the fourth quarter of 2016, a decrease of $240 million, or 10%.

Total revenues were $8.724 billion for the full year of 2017, as compared to $9.674 billion for the full year of 2016, a decrease of $950 million, or 10%. The decline was primarily driven by the impact of divestitures, and lower volumes in the U.S. Diversified Products segment, attributed to the previously reported loss of exclusivity for a basket of products, and the Ortho Dermatologics business. Revenues were also negatively affected by the unfavorable impact of foreign exchange. The decline was partially offset by higher volumes in our Bausch + Lomb/International segment, primarily the U.S. Consumer Products business, and increased international pricing in our Bausch + Lomb/International segment.

Revenues by segment were as follows:

Fourth-Quarter 2017

(in millions)

4Q 2017

4Q 2016

Reported
Change

Reported
Change

Change at
Constant
Currency4

Organic2

Change

Segment











Bausch + Lomb/International

$1,226

$1,261

($35)

(3%)


(5%)


4%

Branded Rx

$602

$744

($142)

(19%)


(19%)


(8%)

U.S. Diversified Products

$335

$398

($63)

(16%)


(16%)


(12%)

Total Revenues

$2,163

$2,403

($240)

(10%)


(11%)


(2%)

Full-Year 2017

(in millions)

FY 2017

FY 2016

Reported
Change

Reported
Change

Change at
Constant
Currency4

Organic2

Change

Segment











Bausch + Lomb/International

$4,871

$4,927

($56)

(1%)


0%


6%

Branded Rx

$2,475

$2,828

($353)

(12%)


(12%)


(6%)

U.S. Diversified Products

$1,378

$1,919

($541)

(28%)


(28%)


(27%)

Total Revenues

$8,724

$9,674

($950)

(10%)


(9%)


(4%)

Bausch + Lomb/International Segment
Bausch + Lomb/International segment revenues were $1.226 billion for the fourth quarter of 2017, as compared to $1.261 billion for the fourth quarter of 2016, a decrease of $35 million, or 3%. Excluding the impact of divestitures and foreign exchange, the Bausch + Lomb/International segment grew organically2 by approximately 4% compared to the fourth quarter of 2016.

Bausch + Lomb/International segment revenues were $4.871 billion for the full year of 2017, as compared to $4.927 billion for the full year of 2016, a decrease of $56 million, or 1%. Excluding the impact of divestitures of $240 million, primarily the skin care divestiture5, and foreign exchange, the Bausch + Lomb/International segment grew organically2 by approximately 6% compared to the full year of 2016, driven primarily by our International Rx, Global Consumer and Global Vision Care businesses.

Branded Rx Segment
Branded Rx segment revenues were $602 million for the fourth quarter of 2017, as compared to $744 million for the fourth quarter of 2016, a decrease of $142 million, or 19%. The Salix business grew revenue by 3% and generated organic growth2 of 5% compared to the fourth quarter of 2016.

Branded Rx segment revenues were $2.475 billion for the full year of 2017, as compared to $2.828 billion for the full year of 2016, a decrease of $353 million, or 12%. The decrease primarily reflects lower volumes in the Ortho Dermatologics business, and the impact of divestitures of $194 million, particularly from the divestiture of Dendreon Pharmaceuticals. Compared to the full year of 2016, the Salix business grew revenue by 2% and generated organic growth2 of 5%.

U.S. Diversified Products Segment
U.S. Diversified Products segment revenues were $335 million for the fourth quarter of 2017, as compared to $398 million for the fourth quarter of 2016, a decrease of $63 million, or 16%.

U.S. Diversified Products segment revenues were $1.378 billion for the full year of 2017, as compared to $1.919 billion for the full year of 2016, a decrease of $541 million, or 28%. The decline was primarily driven by decreases attributed to the previously reported loss of exclusivity for a basket of products.

Operating Income/Loss
Operating loss was $322 million for the fourth quarter of 2017, as compared to an operating income of $150 million for the fourth quarter of 2016, a decrease of $472 million.

Operating income was $102 million for the full year of 2017, as compared to an operating loss of $566 million for the full year of 2016, an improvement of $668 million. The improvement in our operating results for the full year of 2017 reflects gains from divestitures, lower operating expenses, the net decrease in non-cash charges for impairments and net favorable adjustments to acquisition-related contingent consideration. The improvement was partially offset by lower revenues coming from divestitures, the U.S. Diversified Products segment due to the loss of exclusivity for a basket of products, and the Ortho Dermatologics business.

Income Tax
In 2017 the Company recorded an income tax benefit of $4.145 billion, which was primarily attributed to an internal tax reorganization effort, which began in the fourth quarter of 2016 and was completed in the third quarter of 2017, and provisional benefits related to changes under the Tax Cuts and Jobs Act of 2017.

Net Income
Net income for the fourth quarter of 2017 was $513 million, as compared to a net loss of $515 million for the same period in 2016, an increase of $1.028 billion.

Net income for the full year of 2017 was $2.404 billion, as compared to a net loss of $2.409 billion for the full year of 2016, an improvement of $4.813 billion. The change in net income for the full year of 2017 is mainly attributed to an increase in the benefit from income taxes, as described above.

Adjusted net income (non-GAAP) the fourth quarter of 2017 was $347 million, as compared to $443 million for the fourth quarter of 2016, a decrease of $96 million. Adjusted net income (non-GAAP) for the full year of 2017 was $1.349 billion, as compared to $1.916 billion for the full year of 2016, a decrease of $567 million.

Operating Cash
Cash provided by operating activities was $578 million for the fourth quarter of 2017. Cash provided by operating activities was $2.290 billion for the full year of 2017, as compared to $2.087 billion for the full year of 2016, an increase of $203 million, or 10%. The increase in 2017 was primarily due to improvements in operating expenses and working capital.

EPS
GAAP Earnings Per Share (EPS) Diluted for the fourth quarter of 2017 was $1.45, as compared to ($1.47) for the fourth quarter of 2016. GAAP EPS Diluted for the full year of 2017 was $6.83, as compared to ($6.94) for the full year of 2016.

Adjusted EBITDA(non-GAAP)
Adjusted EBITDA (non-GAAP) was $875 million for the fourth quarter of 2017, as compared to $1.047 billion for the fourth quarter of 2016, a decrease of $172 million.

Adjusted EBITDA (non-GAAP) was $3.638 billion for the full year of 2017, as compared to $4.305 billion for the full year of 2016, a decrease of $667 million. The decline for the full year of 2017 was primarily driven by lower revenues coming from divestitures, the U.S. Diversified Products segment due to the loss of exclusivity for a basket of products, and the Ortho Dermatologics business. The decline was partially offset by organic growth2 in the Bausch + Lomb/International segment and the Salix business, and improved management of operating expenses.

2018 Financial Outlook

Valeant has provided guidance for the full year of 2018, as follows:

Full-Year Revenues in the range of $8.10 – $8.30 billion
Full-Year Adjusted EBITDA (non-GAAP) in the range of $3.05 – $3.20 billion

Other than with respect to GAAP Revenues, the Company only provides guidance on a non-GAAP basis. The Company does not provide a reconciliation of forward-looking Adjusted EBITDA (non-GAAP) to GAAP net income (loss), due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation. In periods where significant acquisitions or divestitures are not expected, the Company believes it might have a basis for forecasting the GAAP equivalent for certain costs, such as amortization, which would otherwise be treated as non-GAAP to calculate projected GAAP net income (loss). However, because other deductions (such as restructuring, gain or loss on extinguishment of debt and litigation and other matters) used to calculate projected net income (loss) vary dramatically based on actual events, the Company is not able to forecast on a GAAP basis with reasonable certainty all deductions needed in order to provide a GAAP calculation of projected net income (loss) at this time. The amount of these deductions may be material and, therefore, could result in projected GAAP net income (loss) being materially less than projected Adjusted EBITDA (non-GAAP).

Additional Highlights

Valeant’s cash, cash equivalents and restricted cash (including non-current) were $797 million at Dec. 31, 2017
The Company’s availability under the Revolving Credit Facility was approximately $1.2 billion at Dec. 31, 2017
During the fourth quarter of 2017, Valeant’s corporate credit ratings were revised to stable by Moody’s Investors Service and remained unchanged by other ratings services