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.

On February 28, 2018 Daiichi Sankyo, Inc. ("the Company") reported that it will reorganize its U.S. Commercial organization as it continues to maximize opportunities for its current portfolio and prepare for its upcoming oncology pipeline (Press release, Daiichi Sankyo, FEB 28, 2018, View Source [SID1234524227]). The U.S. restructuring will streamline the Company’s operations, enable it to best serve its current patients and maximize its contribution to the development of medicines that change the standard of care. As part of the reorganization, the Company will reduce headcount by approximately 280 employees from various locations in the U.S.

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"Our priorities are to bring spending in line with revenue, shift resources to maximize Injectafer and our abuse-deterrent pain treatments, and prepare for exciting potential new treatments for patients with cancer being developed by our R&D organization," said Ken Keller, President, Administrative and Commercial, Daiichi Sankyo, Inc. "While the decision to reduce our workforce is a very difficult one, the changes are necessary to position us for long-term success. We are grateful for the contributions of all employees, and we are committed to making this process as easy and as streamlined as possible."

Daiichi Sankyo will offer outplacement services, severance and other support to all employees who are directly affected.

On February 28, 2018 Bayer reported group sales increased by 1.5 percent (Fx & portfolio adj.) to 35.015 billion euros (Press release, Bayer, FEB 28, 2018, View Source;parent=news-overview-category-search-en&ccm=001&presskit=1 [SID1234524316]).

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In 2017, Bayer’s operational business was at the prior-year level. The company made good progress strategically. "We took major steps toward the proposed acquisition of Monsanto," Management Board Chairman Werner Baumann said on Wednesday at the Financial News Conference in Leverkusen. Pharmaceuticals achieved another record year in business operations. Sales and earnings declined at both Consumer Health and Crop Science – in the latter case, however, this development was attributable to the difficult situation in Brazil. Animal Health posted an increase in sales and earnings. "We remain focused on our objectives and are convinced of our long-term perspective. We therefore have every reason to look to the future with optimism," said Baumann.

Bayer received further approvals last year for the proposed acquisition of Monsanto. "Only recently, the Brazilian antitrust authorities gave the green light. That is an important milestone on the road to closing this transaction. After all, Brazil is one of the world’s most important agricultural markets," Baumann said. Overall, more than half of the around 30 authorities worldwide have now approved the acquisition. Although Bayer is continuing to cooperate closely with the institutions involved, it is becoming evident that the examination procedures will require more time. "Our goal now is to be able to close the transaction in the second quarter of 2018," Baumann explained. "This does not affect our expectation of a successful conclusion to the regulatory review, nor our conviction that this is the right step."

Of importance last year in connection with the proposed acquisition of Monsanto and the associated merger control proceedings was the contractual agreement to sell certain Crop Science businesses to BASF. "We have now also committed to divest our entire vegetable seed business. Certain additional business activities of Bayer and Monsanto may also be sold or out-licensed," Baumann said. Thus Bayer is actively addressing observations expressed by antitrust authorities. Any sales and licenses would be subject to a successful closing of the proposed acquisition of Monsanto, which remains subject to customary closing conditions, including receipt of required regulatory approvals.

According to Baumann, the company last year took a big step toward its goal of achieving full separation from Covestro in the medium term by selling approximately 36 percent of the interest in that company for 4.7 billion euros. Bayer ceded de facto control of Covestro and deconsolidated the company at the end of September. Bayer’s direct interest in Covestro currently amounts to 14.2 percent. Another 8.9 percent is held by Bayer Pension Trust.

"Operationally, 2017 was a year of ups and downs," said the Bayer CEO. Sales of the Bayer Group rose by 1.5 percent on a currency- and portfolio-adjusted basis (Fx & portfolio adj.) (reported: 0.2 percent) to 35.015 billion euros. At 9.288 billion euros, EBITDA before special items was level with the previous year despite negative currency effects. EBIT rose by 2.9 percent to 5.903 billion euros after special charges of 1.227 billion euros (2016: 1.088 billion euros). The special charges comprised mainly impairment losses on intangible assets, expenses in connection with the proposed acquisition of Monsanto and efficiency improvement programs, and provisions for litigations and legal risks. EBIT before special items increased by 4.5 percent to 7.130 billion euros. Net income increased by 61.9 percent to 7.336 billion euros and core earnings per share from continuing operations by 1.0 percent to 6.74 euros.

Operating cash flow from continuing operations climbed by 2.7 percent to 6.611 billion euros. "We are pleased that we were able to substantially reduce our net financial debt in 2017," said Chief Financial Officer Johannes Dietsch. Net financial debt declined by 69.5 percent to 3.595 billion euros. There were cash inflows from operating activities and from the sale of Covestro shares. "We are therefore in a good position for the pending financing activities connected with the proposed acquisition of Monsanto," said Dietsch.

Pharmaceuticals: Earnings growth stronger than sales increase

Sales of prescription medicines (Pharmaceuticals) increased by 4.3 percent (Fx & portfolio adj.) to 16.847 billion euros – a new record. "The success of the division was once again driven by our key growth products," said Baumann. Total sales of the anticoagulant Xarelto, the eye medicine Eylea, the cancer drugs Stivarga and Xofigo and the pulmonary hypertension treatment Adempas advanced by 16.3 percent (Fx adj.) to 6.196 billion euros. The development in sales of Xofigo was particularly strong at 25.6 percent (Fx adj.), due mainly to its market launch in Japan in 2016 and to higher demand in the United States. Business with Xarelto expanded by 13.9 percent (Fx adj.), primarily on account of higher volumes in Europe, Japan and China. Bayer also posted gains for its license revenues – recognized as sales – in the United States, where Xarelto is marketed by a subsidiary of Johnson & Johnson. Sales of Eylea climbed by 18.5 percent (Fx adj.), due especially to expanded volumes in Europe, Canada and Japan.

Among the other leading pharmaceutical products, the hormone-releasing intrauterine devices of the Mirena product family posted sales growth of 9.2 percent (Fx adj.), benefiting from higher volumes of the low-dose intrauterine device Kyleena, particularly in the United States and Europe. Marked sales gains were also achieved with Aspirin Cardio for the secondary prevention of heart attacks (Fx adj. 10.5 percent) and the diabetes treatment Glucobay (Fx adj. 13.0 percent), mainly as a result of a continued positive business performance in China. Sales of the Kogenate/Kovaltry blood-clotting medicines were down by 15.9 percent (Fx adj.) due to lower order volumes being placed for the active ingredient by a distribution partner ahead of the planned contract termination at the end of the year. Adjusted for this development, sales of this product were at the prior-year level.

EBITDA before special items of Pharmaceuticals increased by 8.8 percent to 5.711 billion euros. Growth was mainly driven by higher volumes. By contrast, negative currency effects diminished earnings by 98 million euros.

Sales and earnings of Consumer Health down

Sales of self-care products (Consumer Health) declined by 1.7 percent (Fx and portfolio adj.) to 5.862 billion euros. "This was due to persistently weak business development in the United States," said Baumann. Furthermore, the Chinese authorities unexpectedly changed the legal status of two of Bayer’s medicated skincare brands from OTC to prescription, which led to sales declines in the fourth quarter of 2017. By contrast, business expanded slightly in Europe/Middle East/Africa, while sales in Latin America came in at the prior-year level (Fx adj.).

Business with the Bepanthen / Bepanthol wound and skin care products expanded by 6.6 percent (Fx adj.), with gratifying sales gains particularly in Europe/Middle East/Africa, and especially in Germany. Sales of the Canesten skin and intimate health products grew by 3.5 percent (Fx adj.), in a development that was mainly attributable to a positive business performance in China and the United Kingdom. There was a substantial 7.9 percent (Fx adj.) decline in sales of the analgesic Aleve, which had benefited in 2016 from a product line extension and faced intense competition in the United States in 2017.

EBITDA before special items of Consumer Health declined by 12.8 percent to 1.231 billion euros. This was largely due to lower volumes, in part as a consequence of the reverse switch in China and the associated EBITDA effect of around 50 million euros. Earnings were also held back by a higher cost of goods sold, primarily as a result of inventory impairments, as well as by currency effects of 25 million euros and higher selling expenses. Positive contributions came from one-time gains, including particularly 80 million euros from the divestment of noncore brands.

Crop Science held back by situation in Brazil

Sales in the agriculture business (Crop Science) moved back by 2.2 percent (Fx & portfolio adj.) to 9.577 billion euros. This was mainly due to the situation in the Brazilian crop protection business, where volumes were held back by unexpectedly high inventories in the market. "We have initiated a number of measures to normalize this situation. For example, we took back crop protection products from our distribution partners and concluded new agreements at amended terms," said Baumann. "We are now seeing that these measures are taking effect." When the Brazilian business is excluded, sales of Crop Science rose by 3.0 percent (Fx & portfolio adj.). Sales declined by 18.0 percent (Fx adj.) in Latin America but grew strongest, by 5.8 percent (Fx adj.), in North America, followed by Asia/Pacific and Europe/Middle East/Africa.

The Seeds business (seed and plant traits) posted positive development, with sales gains of 9.1 percent (Fx & portfolio adj.). Environmental Science, the business with products for nonagricultural applications, saw sales increase by an even more substantial 14.0 percent (Fx & portfolio adj.). By contrast, there was a decline of 5.3 percent (Fx & portfolio adj.) at Crop Protection. Fungicides (Fx & portfolio adj.: minus 9.9 percent) and Insecticides (Fx & portfolio adj.: minus 6.1 percent) saw disproportionate declines in sales – unlike Herbicides and SeedGrowth (seed treatment products), where the declines were much less marked at 1.6 and 0.3 percent (Fx & portfolio adj.), respectively.

EBITDA before special items of Crop Science declined by 15.6 percent to 2.043 billion euros. This decline is largely attributable to the situation in Brazil, which resulted in lower selling prices and volumes. Negative currency effects of 63 million euros were an additional factor.

Animal Health posts gains in Asia/Pacific and North America

Sales of Animal Health increased by 2.0 percent (Fx and portfolio adj.) to 1.571 billion euros. Business in the Asia/Pacific region developed especially positively due to higher demand and price increases. Sales also grew in North America. The Seresto flea and tick collar posted continued strong growth of 25.1 percent (Fx adj.). Sales of the Advantage family of flea, tick and worm control products decreased by 7.8 percent (Fx adj.) year on year. EBITDA before special items rose by 9.2 percent to 381 million euros. Price increases, the Cydectin business acquired by Bayer in January 2017 and lower selling expenses had a positive impact on earnings.

Core earnings per share increased in the fourth quarter of 2017

Sales of the Bayer Group in the fourth quarter of 2017 rose by 2.7 percent (Fx & portfolio adj.), to 8.596 billion euros. EBITDA before special items declined by 1.3 percent to 1.783 billion euros. By contrast, EBIT climbed by 6.7 percent to 625 million euros. Net income fell by 67.3 percent to 148 million euros. This included a negative special effect of 455 million euros that relates to the tax reform in the United States. By contrast, core earnings per share from continuing operations improved by 28.2 percent to 1.41 euros.

Sales and earnings in 2018 expected to be at the prior-year level despite currency losses

Based on the exchange rates as of December 31, 2017, Bayer expects sales of around 35 billion euros for 2018. Sales, EBITDA before special items and core earnings per share are expected to be at the prior-year level. On a currency- and portfolio-adjusted basis, Bayer expects sales to increase by a low- to mid-single-digit percentage, while EBITDA before special items and core earnings per share from continuing operations are each predicted to grow by a mid-single-digit percentage after adjusting for currency effects. The forecast takes into account temporary supply interruptions due to remediation measures in production. Bayer expects the impact on adjusted EBITDA to be about 300 million euros. The largest proportion of this amount is related to the Pharmaceuticals Division and a minor part to the Consumer Health Division.

For Pharmaceuticals, Bayer plans to generate sales of more than 16.5 billion euros. This corresponds to a low-single-digit percentage increase on a currency- and portfolio-adjusted basis. The division aims to raise sales of the key growth products Xarelto, Eylea, Stivarga, Xofigo and Adempas toward 7 billion euros. Bayer expects EBITDA before special items to decline by a low-single-digit percentage (Fx adj.: increase by a low-single-digit percentage) and anticipates a slight decline in the EBITDA margin before special items.

At Consumer Health, Bayer expects sales of more than 5.5 billion euros, which would be at the prior-year level on a currency- and portfolio-adjusted basis. Bayer expects EBITDA before special items to decline by a low-single-digit percentage (Fx adj.: increase by a low-single-digit percentage).

For Crop Science, Bayer sees sales coming in at more than 9.5 billion euros. This corresponds to a mid-single-digit percentage increase on a currency- and portfolio-adjusted basis. Bayer expects to increase EBITDA before special items by a mid- to high-single-digit percentage (Fx adj.: mid-teens percentage increase).

At Animal Health, Bayer expects a currency- and portfolio-adjusted increase in sales by a low-single-digit percentage. The company expects EBITDA before special items to decline by a mid-single-digit percentage (Fx adj.: at the prior-year level). Both sales and EBITDA before special items are negatively impacted by revised financial reporting standards (IFRS 15).

Through the expected acquisition of Monsanto in the second quarter of 2018, Bayer anticipates a significant increase in sales and EBITDA before special items. Based on current assumptions about the equity and financing measures to be undertaken, Bayer expects a moderate decline in core earnings per share. For the first full year following the acquisition, Bayer continues to expect a significant increase in sales and EBITDA before special items, and an increase in core earnings per share.

Pacira 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, Pacira Pharmaceuticals, 2018, FEB 28, 2018, View Source [SID1234524217]).

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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.