Navidea Biopharmaceuticals Schedules Fourth Quarter and Full Year 2017 Earnings Conference Call and Business Update

On February 28, 2018 Navidea Biopharmaceuticals (NYSE MKT: NAVB) ("Navidea" or "the Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported it will host a conference call on March 8, 2018 at 4:30pm E.T. to discuss its financial results for the fourth quarter and full year 2017, in conjunction with the filing of its annual report on Form 10-K for the fourth quarter and full year results ended December 31, 2017 (Press release, Navidea Biopharmaceuticals, FEB 28, 2018, View Source [SID1234524252]).

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Michael Goldberg, President and Chief Executive Officer, and Jed Latkin, Chief Financial and Operating Officer of Navidea, will host the call and provide an update on recent developments and clinical progress. Management will be answering questions live immediately following the earnings announcement part of the call.

To participate in the call, please dial +1 646-828-8143 (toll-free) in the U.S. and Canada. The conference ID number is 1826783.

Event: FY+ 2017 Earnings and Business Update Conference Call
Date: Thursday, March 8th, 2018
Time: 4:30pm E.T.
U.S. & Canada Dial-in: +1 646-828-8143 (toll free)
Conference ID: 1826783

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

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.

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An archived version will be available within approximately 4 hours of the live presentation, and can be accessed at the same location for 180 days.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

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"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

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

TESARO 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, TESARO, 2018, FEB 28, 2018, View Source [SID1234524218]).

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Pacira Reports Fourth Quarter and Full Year 2017 Financial Results and Provides Business Update

On February 28, 2018 Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) reported financial results for the fourth quarter and full year of 2017 and its outlook for 2018 (Press release, Pacira Pharmaceuticals, FEB 28, 2018, View Source;p=RssLanding&cat=news&id=2335267 [SID1234524254]).

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"2017 was a year of solid progress and set the stage for an important year ahead," said Dave Stack, chairman and chief executive officer of Pacira. "EXPAREL has now been used in over 3.5 million patients across the United States and continues to grow. We remain steadfast in our mission to provide a non-opioid option to as many patients as possible, including defining the next steps for the expanded nerve block indication through our pending sNDA. Our strategic partnership with Johnson & Johnson continues to drive EXPAREL use within the orthopedic setting. In addition, we are advancing key collaborations to support best-practice opioid minimization strategies. Finally, our education and awareness campaigns are bearing fruit as more and more key stakeholders including patients, physicians, medical societies and advocacy organizations are recognizing and appreciating the benefits of non-opioid postsurgical pain control."

Highlights and Recent Events

Collaboration with The University of Tennessee Medical Center and CQ-Insights to minimize opioid use after hernia surgery. In February 2018, The University of Tennessee Medical Center and Pacira announced a continuous quality improvement (CQI) project designed to develop low-or no-opioid postsurgical pain management pathways for patients undergoing one of the most common surgical procedures, hernia surgery.

FDA’s Anesthetic and Analgesic Drug Products Advisory Committee did not support approval of the EXPAREL sNDA for nerve block. In February 2018, the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee’s (AADPAC) reviewed the company’s supplemental New Drug Application, or sNDA, seeking expansion of the EXPAREL label to include administration via nerve block for prolonged regional analgesia. The AADPAC voted six to four against approval of the expanded indication. The committee’s feedback will be considered for the FDA in its review of the sNDA. The FDA’s Prescription Drug User Fee Act goal date for completion of its review is April 6, 2018.

Partnership with WellStar Health Systems to minimize opioid use and standardize outcomes across surgical procedures. In January 2018, WellStar Health System, the largest health system in Georgia, and Pacira announced a joint commitment to address opioid use and dependence following surgery. Through a comprehensive opioid minimization strategy, the organizations will work together to educate hospital clinicians and administrators about the burden of postsurgical opioids; develop enhanced recovery protocols to reduce use in key surgical procedures; and standardize the rollout of these protocols across WellStar’s 11 hospitals.

Promotions of Scott Braunstein, MD, to Chief Operating Officer and Richard Scranton, MD, to Chief Scientific Officer. In December 2017, Scott Braunstein, MD, was named Chief Operating Officer and Richard Scranton, MD, was named Chief Scientific Officer. Dr. Braunstein is overseeing the company’s commercial and medical affairs functions while continuing to manage strategy and corporate development. As Chief Scientific Officer, Dr. Scranton is directing the company’s clinical research while continuing to lead scientific communications, market access, and health outcomes research and analytics for EXPAREL.

Collaboration with Illinois Surgical Quality Improvement Collaborative to minimize opioid exposure for postsurgical patients. In December 2017, the Illinois Surgical Quality Improvement Collaborative, a nationally recognized partnership of 56 Illinois hospitals, and Pacira announced an initiative to jointly develop programs and resources that will support best practice pain management prescribing for surgical patients throughout the state of Illinois. The focus of the initiative is to develop and provide intensive, interactive educational tools for hospitals in order to improve adherence to evidence-based best practices for perioperative pain management.

Collaboration with Cancer Treatment Centers of America to educate physicians and patients about responsible opioid use. In November 2017, Cancer Treatment Centers of America, a national network of five hospitals and Pacira announced a new collaboration dedicated to reducing the risk of opioid dependence among cancer patients. The goal of the Opioid Risk Reduction Initiative—an education effort focused on responsible use and increased awareness of opioid alternatives—is to improve the cancer patient experience through expanded pain management options.

Fourth Quarter 2017 Financial Results

EXPAREL net product sales were $78.7 million in the fourth quarter of 2017, a 10% increase over the $71.4 million reported for the fourth quarter of 2016.

Total revenues were $79.1 million in the fourth quarter of 2017, an 8% increase over the $72.9 million reported for the fourth quarter of 2016.

Total operating expenses were $70.6 million in the fourth quarter of 2017, compared to $75.4 million in the fourth quarter of 2016.

GAAP net income was $4.6 million, or $0.11 per share (basic and diluted), in the fourth quarter of 2017, compared to a GAAP net loss of $4.0 million, or $0.11 per share (basic and diluted), in the fourth quarter of 2016.

Non-GAAP net income was $16.0 million, or $0.39 per share (basic) and $0.38 per share (diluted), in the fourth quarter of 2017, compared to non-GAAP net income of $3.6 million, or $0.10 per share (basic) and $0.09 per share (diluted), in the fourth quarter of 2016.

Pacira had 40.6 million basic weighted average shares of common stock outstanding in the fourth quarter of 2017.

Pacira had 41.6 million diluted weighted average shares of common stock outstanding in the fourth quarter of 2017.

Full-Year 2017 Financial Results

EXPAREL net product sales were $282.9 million in 2017, a 6% increase over the $265.8 million reported in 2016.

Total revenues were $286.6 million in 2017, a 4% increase over the $276.4 million reported in 2016.

Total operating expenses were $311.6 million in 2017, compared to $308.4 million in 2016.

GAAP net loss was $42.6 million, or $1.07 per share (basic and diluted) in 2017, compared to a GAAP net loss of $37.9 million, or $1.02 per share (basic and diluted) in 2016.

Non-GAAP net income was $8.6 million, or $0.22 per share (basic) and $0.21 per share (diluted), in 2017, compared to non-GAAP net income of $25.2 million, or $0.68 per share (basic) and $0.62 per share (diluted), in 2016.

Pacira ended 2017 with cash, cash equivalents, short-term and long-term investments ("cash") of $371.4 million.

Pacira had 39.8 million basic weighted average shares of common stock outstanding in 2017.

For non-GAAP measures, Pacira had 41.4 million diluted weighted average shares of common stock outstanding in 2017.

2018 Outlook

Pacira announces its full year 2018 financial guidance as follows. Pacira expects:

EXPAREL net product sales of $300 million to $310 million.

Non-GAAP gross margins of 70% to 72%.

Non-GAAP research and development (R&D) expense of $50 million to $60 million.

Non-GAAP selling, general and administrative (SG&A) expense of $150 million to $160 million.

Stock-based compensation of $30 million to $35 million.

See "Non-GAAP Financial Information" and "Reconciliations of GAAP to Non-GAAP 2018 Financial Guidance" below.

Today’s Conference Call and Webcast Reminder

The Pacira management team will host a conference call to discuss the company’s financial results and recent developments today, Wednesday, February 28, 2018, at 8:30 a.m. ET. The call can be accessed by dialing 1-877-845-0779 (domestic) or 1-720-545-0035 (international) ten minutes prior to the start of the call and providing the Conference ID 5198726.

A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and providing the Conference ID 5198726. The replay of the call will be available for two weeks from the date of the live call.

The live, listen-only webcast of the conference call can also be accessed by visiting the "Investors & Media" section of the company’s website at investor.pacira.com. A replay of the webcast will be archived on the Pacira website for two weeks following the call.

Non-GAAP Financial Information

This press release contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), such as non-GAAP net income, non-GAAP cost of goods sold, non-GAAP gross margins, non-GAAP research and development (R&D) expense and non-GAAP selling, general and administrative (SG&A) expense, because such measures exclude stock-based compensation, amortization of debt discount, loss on early extinguishment of debt, a contract termination fee with CrossLink BioScience, LLC, or CrossLink, exit costs related to the discontinuation of DepoCyt(e) production and inventory and related reserves from 2016.

These measures supplement the company’s financial results prepared in accordance with GAAP. Pacira management uses these measures to better analyze its financial results, estimate its future cost of goods sold, gross margins, R&D expense and SG&A expense outlook for 2018 and to help make managerial decisions. In management’s opinion, these non-GAAP measures are useful to investors and other users of our financial statements by providing greater transparency into the operating performance at Pacira and the company’s future outlook. Such measures should not be deemed to be an alternative to GAAP requirements or a measure of liquidity for Pacira. Non-GAAP measures are also unlikely to be comparable with non-GAAP disclosures released by other companies. See the tables below for a reconciliation of GAAP to non-GAAP measures, and a reconciliation of our GAAP to non-GAAP 2018 financial guidance for gross margins, R&D expense and SG&A expense.