On February 27, 2020 ANI Pharmaceuticals, Inc. ("ANI") (NASDAQ: ANIP) reported its financial results for the three and twelve months ended December 31, 2019 and provided its 2020 financial guidance (Press release, ANI Pharmaceuticals, FEB 27, 2020, https://www.prnewswire.com/news-releases/ani-pharmaceuticals-reports-full-year-and-fourth-quarter-2019-results-provides-2020-guidance-and-remains-on-track-to-submit-cortrophin-gel-snda-to-fda-in-march-2020-301012068.html [SID1234554944]). The Company will host its earnings conference call this morning, February 27, 2020, at 10:30 AM ET. Investors and other interested parties can join the call by dialing (866) 776-8875. The conference ID is 4783883.

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"ANI generated record net revenues and non-GAAP gross profit in 2019 while continuing to diversify its commercial product offering and pipeline opportunities. While revenues and non-GAAP gross profit for three of our important generic products were negatively impacted in recent periods, overall our business remains resilient, and we look forward to leveraging important recent launches such as Vancomycin Oral Solution and Bretylium Tosylate Injection as well as the recently acquired Amerigen portfolio in 2020. During 2019, we launched several new products, entered into collaborative arrangements with strategic partners and acquired both previously approved and development stage products we plan to launch in the future. We have utilized strong operating cash flows for asset acquisitions and investment into our portfolio of pipeline products and expect to continue to do so in the future.

During the fourth quarter, we successfully completed our fourth commercial scale batch of both Corticotropin API and the Cortrophin Gel drug product, and importantly, remain on track to submit our supplemental NDA filing in March 2020."

2020 Financial Guidance

For the twelve months ending December 31, 2020, ANI is providing guidance on net revenue, adjusted non-GAAP EBITDA, and adjusted non-GAAP diluted earnings per share. The following table summarizes 2020 guidance as compared to 2019 actual results:

In addition, we expect that adjusted non-GAAP gross margin, defined as the result of Net Revenues less Cost of Sales (excluding depreciation and amortization) as a percentage of Net Revenues, will decline from approximately 71% in 2019 to the mid 60% range in 2020, driven by the impact of negative price and product mix. Year over year changes of our Adjusted non-GAAP diluted earnings per share metric differ from our Adjusted non-GAAP EBITDA metric due to a projected increase in cash interest expense resulting from the refinancing of our convertible debt to bank debt.

ANI’s full year 2020 financial guidance reflects management’s current assumptions regarding customer relationships, product pricing, prescription trends, competition, inventory levels, cost of sales, operating costs, timing of research and development spend, taxes, and the anticipated timing of future product launches and other key events.

Cortrophin Gel Re-commercialization Update

Product

Required Filing

Expected Filing Date

Total Annual Market(d)

Cortrophin Gel

sNDA

March 2020

$1.0 billion

(d) Based on data from IQVIA

We continue to successfully progress our Cortrophin Gel re-commercialization program. Significant accomplishments since the third quarter 2019 press release (dated November 6, 2019) include:

ANI successfully completed API process validation by completing the fourth commercial scale batch of Corticotropin API. ANI also completed manufacturing for a fifth commercial scale batch of Corticotropin API. All five commercial scale batches were analytically consistent with each other and met all API release specifications. ANI expects to have 6 months stability on all API registration batches prior to the sNDA filing and by the end of first quarter 2020.
ANI successfully completed drug product process validation in the fourth quarter of 2019. ANI also completed manufacturing of a fourth commercial scale batch of Cortrophin Gel. This batch was analytically consistent with previously manufactured batches and met all drug product release specifications. ANI had already completed manufacturing for three commercial scale registration stability batches of Cortrophin Gel and expects to have 6 months stability on each prior to the sNDA filing and by the end of first quarter 2020.
ANI is on track to file the sNDA as planned by March 2020.

For further details, please see ANI’s Cortrophin Gel Re-commercialization Milestone Update in Table 5.

Fourth Quarter Results

Generic Pharmaceutical Products

Fourth Quarter Net Revenues – Results and Update

Net revenues from sales of generic pharmaceuticals decreased 14% to $29.1 million from $33.7 million in the prior period, primarily due to decreases in sales of Esterified Estrogen with Methlytestosterone ("EEMT"), Erythromycin Ethylsuccinate ("EES"), Propafenone, and Fenofibrate. These decreases were tempered by the September 2019 launch of Vancomycin HCl for Oral Solution as well as increased unit sales of Vancomycin tablets.

Branded Pharmaceutical Products

Fourth Quarter Net Revenues – Results and Update

Net revenues from sales of branded pharmaceuticals decreased 17% to $15.6 million from $18.8 million in the prior period, primarily due to decrease in sales of Inderal LA, Atacand and Atacand HCT. These decreases were tempered by increased sales of InnoPran XL.

Contract Manufacturing

Fourth Quarter Net Revenues – Results and Update

Contract manufacturing revenues decreased 28% to $2.6 million from $3.7 million in the prior year period, due to the timing and volume of orders from contract manufacturing customers in the period.

Royalty and Other

Fourth Quarter Net Revenues – Result and Update

Royalty and Other decreased 34% to $0.6 million from $0.9 million, primarily due to the timing and volume of product development and laboratory services revenue earned by ANI Canada.

Operating Expenses

Operating expenses increased to $52.6 million for the three months ended December 31, 2019, from $45.7 million in the prior year period. The increase was primarily due to the following:

$6.5 million in the build of Cortrophin pre-launch commercial inventories (which are expensed for US GAAP); there were no such activities in 2018,
$1.2 million increase in research and development expense, primarily due to Q4 2019 development-based milestone payments earned by collaborative partners, and
$0.9 million increase in depreciation and amortization expense, primarily due to additional amortization expense associated with a March 2019 asset acquisition and a January 2019 royalty buyout payment related to a prior period asset acquisition.
These increases were partially offset by a $2.3 million decrease in cost of sales as a result of the previously mentioned royalty buyout in January 2019 and a decrease in sales over the comparable periods, tempered by Q4 2019 inventory reserve charges of $4.6 million primarily related to the Company’s exit from the Methylphenidate Extended Release market.

Cost of sales as a percentage of net revenues increased to 37% during the three months ended December 31, 2019, from 35% during same period in 2018. The increase was primarily due to the inventory reserve charges recognized in the fourth quarter 2019 and negative price, which were tempered by reductions related to the 2019 royalty buyout.

Net Loss and Diluted Loss per Share

Net loss was $4.8 million for the three months ended December 31, 2019, as compared to net income of $5.4 million in the prior year period. The net loss was driven by the previously mentioned $6.5 million build of Cortrophin pre-launch commercial inventories and $4.6 million of inventory reserve charges. The effective consolidated tax benefit rate for the three months ended December 31, 2019 was 37%.

Diluted loss per share for the three months ended December 31, 2019 was $0.41, based on 11,886 thousand diluted shares outstanding, as compared to diluted earnings per share of $0.46 in the prior year period. Adjusted non-GAAP diluted earnings per share was $1.08, as compared to adjusted non-GAAP diluted earnings per share of $1.32 in the prior year period. For a reconciliation of adjusted non-GAAP diluted earnings per share to the most directly comparable GAAP financial measure, please see Table 4.

ANI Product Development Pipeline

ANI’s pipeline consists of 118 products, addressing a total annual market size of $7.0 billion, based on data from IQVIA. Of these, ANI expects that at least 52 can be commercialized based on either CBE-30s or prior approval supplements filed with the FDA.

Non-GAAP Financial Measures

The Company’s fiscal 2019 guidance for adjusted non-GAAP EBITDA and adjusted non-GAAP diluted earnings per share is not reconciled to the most comparable GAAP measure. This is due to the inherent difficulty of forecasting the timing or amount of items that would be included in a reconciliation to the most directly comparable forward-looking GAAP financial measures. Because a reconciliation is not available without unreasonable effort, it is not included in this release.

Adjusted non-GAAP EBITDA

ANI’s management considers adjusted non-GAAP EBITDA to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by non-cash stock-based compensation and differences in capital structures, tax structures, capital investment cycles, ages of related assets, and compensation structures among otherwise comparable companies. Management uses adjusted non-GAAP EBITDA when analyzing Company performance.

Adjusted non-GAAP EBITDA is defined as net income/(loss), excluding tax expense, interest expense, depreciation, amortization, the excess of fair value over cost of acquired inventory, stock-based compensation expense, expense from acquired in-process research and development, gains, losses, and expenses related to the repurchase of convertible debt, expenses related to debt financing, transaction and integration expenses, non-cash impairment charges, Cortrophin pre-launch charges, other income / expense and certain other items, including expensed milestone payments and inventory reserve charges, that vary in frequency and impact on ANI’s results of operations. Adjusted non-GAAP EBITDA should be considered in addition to, but not in lieu of, net income or loss reported under GAAP. A reconciliation of adjusted non-GAAP EBITDA to the most directly comparable GAAP financial measure is provided in Table 3.

Adjusted non-GAAP Net Income

ANI’s management considers adjusted non-GAAP net income to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by purchase accounting adjustments, non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, non-cash impairment charges, Cortrophin pre-launch charges and certain other items, including expensed milestone payments and inventory reserve charges, that vary in frequency and impact on ANI’s results of operations. Management uses adjusted non-GAAP net income when analyzing Company performance.

Adjusted non-GAAP net income is defined as net income/(loss), plus the excess of fair value over cost of acquired inventory, stock-based compensation expense, transaction and integration expenses, gains, losses, and expenses related to the repurchase of convertible debt, expenses related to debt financing, non-cash interest expense, depreciation and amortization expense, expense from acquired in-process research and development, non-cash impairment charges, Cortrophin pre-launch charges and certain other items, including expensed milestone payments and inventory reserve charges, that vary in frequency and impact on ANI’s results of operations, less the tax impact of these adjustments calculated using an estimated statutory tax rate. Management will continually analyze this metric and may include additional adjustments in the calculation in order to provide further understanding of ANI’s results. Adjusted non-GAAP net income should be considered in addition to, but not in lieu of, net income reported under GAAP. A reconciliation of adjusted non-GAAP net income to the most directly comparable GAAP financial measure is provided in Table 4.

Adjusted non-GAAP Diluted Earnings per Share

ANI’s management considers adjusted non-GAAP diluted earnings per share to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by purchase accounting adjustments, non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, non-cash impairment charges, Cortrophin pre-launch charges and certain other items, including expensed milestone payments and inventory reserve charges, that vary in frequency and impact on ANI’s results of operations.

Management uses adjusted non-GAAP diluted earnings per share when analyzing Company performance.

Adjusted non-GAAP diluted earnings per share is defined as adjusted non-GAAP net income, as defined above, divided by the diluted weighted average shares outstanding during the period, as adjusted for the dilutive effect of the convertible debt notes (in 2019), when applicable. Management will continually analyze this metric and may include additional adjustments in the calculation in order to provide further understanding of ANI’s results. Adjusted non-GAAP diluted earnings per share should be considered in addition to, but not in lieu of, diluted earnings or loss per share reported under GAAP. A reconciliation of adjusted non-GAAP diluted earnings per share to the most directly comparable GAAP financial measure is provided in Table 4.

On February 27, 2020 Cryoport, Inc. (NASDAQ: CYRX) (NASDAQ: CYRXW) ("Cryoport" or the "Company"), a global leader in life sciences solutions, reported that the Company will report financial results for the fourth quarter and fiscal year ended December 31, 2019 on Thursday, March 5, 2020 after U.S. markets close (Press release, Cryoport, FEB 27, 2020, View Source [SID1234554942]).

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In addition to the earnings release, a document titled "Cryoport 2019 Year in Review", which will provide a review of Cryoport’s recent financial and operational performance and a general business update, will be issued by management at 4:05 pm ET on Thursday, March 5, 2020. The document is designed to be read by investors before the questions and answers conference call and can be accessed at http://ir.cryoport.com/events-and-presentations.

Cryoport management will host a conference call at 5:00 pm ET on March 5, 2020. The conference call will be in the format of a questions and answers session and will address any queries investors have regarding the Company’s reported results.

Conference Call Information

Date:

March 5, 2020

Time:

5:00 p.m. ET

Dial-in numbers:

+1 (855) 327-6837 (U.S.), +1 (631) 891-4304 (International)

Confirmation code:

Request the "Cryoport Call"

Live webcast:

‘Investor Relations’ section at www.cryoport.com or at this link. Please allow 10 minutes prior to the call to visit this site to download and install any necessary audio software.

An archive of the question and answer webcast will be available approximately three hours after completion of the live event and will be accessible on the Investor Relations section of the Company’s website at www.cryoport.com for a limited time. To access the replay of the webcast, please follow this link. A dial-in replay of the call will also be available to those interested until March 12, 2020. To access the replay, dial +1 (844) 512-2921 (United States) or +1 (412) 317-6671 (International) and enter replay pin number: 10008682.

On February 27, 2020 Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) ("Oramed" or "Company"), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, reported the pricing of an underwritten public offering of 5,250,000 shares of its common stock at a public offering price of $4.00 per share (Press release, Oramed Pharmaceuticals, FEB 27, 2020, View Source [SID1234554941]). All of the shares in the offering are to be sold by Oramed. Oramed has granted the underwriters a 45-day option to purchase up to 787,500 additional shares of common stock at the public offering price, less the underwriting discount. The offering is expected to close on or about March 2, 2020, subject to the satisfaction of customary closing conditions.

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The gross proceeds from the offering, before deducting the underwriting discount and estimated offering expenses payable by Oramed, are expected to be $21 million. The Company intends to use the net proceeds of the offering for its anticipated Phase 3 clinical trial in ORMD-0801 (Oral Insulin) and for other clinical trials and research and development activities as well as for general corporate purposes.

National Securities Corporation, a wholly owned subsidiary of National Holdings Corporation, is acting as the sole book running manager for the offering.

A.G.P./Alliance Global Partners is acting as financial advisor for the offering.

The shares of common stock are being offered by Oramed pursuant to its shelf registration statement on Form S-3 (File No. 333-236194) previously filed and declared effective by the Securities and Exchange Commission (the "SEC") on February 10, 2020. The offering is being made only by means of a prospectus supplement and accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the underwritten public offering have been filed with the SEC and are available on the SEC’s website at View Source A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from National Securities Corporation, Attn: Charles Wanyama, 200 Vesey Street, 25th Floor, New York, New York 10281, telephone: (212) 417-3634, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On February 27, 2020 Debiopharm (www.debiopharm.com), a Swiss-based, global biopharmaceutical company, reported that the American Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation for Debio 1143, the most clinically advanced IAP antagonist, for the treatment of patients with confirmed diagnosis of previously untreated, unresectable locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN) in combination with current standard of care, cisplatin-based concomitant standard fractionation chemoradiation therapy (CRT) (Press release, Debiopharm, FEB 27, 2020, View Source;neck-cancer-301012713.html [SID1234554940]). Ongoing clinical investigations have been developed to evaluate the benefit of increasing tumor cell sensitivity to CRT, making the addition of Debio 1143 a highly promising strategy for radio-oncologists to improve treatment outcomes for high-risk LA-SCCHN.

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This Breakthrough Therapy Designation is based on the clinically compelling phase II study results (NCT02022098) presented at the ESMO (Free ESMO Whitepaper) Congress 2019 in Barcelona, Spain. They revealed a very significant improvement of the primary endpoint locoregional control rate at 18 months after CRT (21% improvement vs. control arm) and a marked Progression-Free Survival (PFS) benefit vs. the CRT+placebo arm after a 2-year follow-up period (HR=0.37, p=0.007). In addition, the compound showed a predictable and manageable safety profile, that did not compromise the full delivery of standard CRT.

"Despite today’s current standard of care, high-risk locally-advanced head and neck cancer remains an area of unmet medical need. This Breakthrough Therapy Designation will allow us to maximize the potential of Debio 1143 to become an innovative radio-chemo enhancing treatment for LA-SCCHN patients," commented Angela Zubel, Chief Development Officer, Debiopharm.

"This FDA assessment is a strong encouragement to expand investigations into other cancer types where the radio-sensitization effect of Debio 1143 could also provide further benefits over the current standard of care," expressed Sergio Szyldergemajn, Medical Director of Oncology at Debiopharm.

Breakthrough Therapy Designation is intended to expedite the clinical development and review of medicines showing substantial improvements in serious or life-threatening conditions so that patients can access innovative therapies as soon as possible.

About Head and Neck Cancer
Squamous cell carcinoma of the head and neck (SCCHN) is the 6th most common cancer type worldwide, with more than half of patients diagnosed with locally-advanced (LA) disease.1-2 High-risk LA-SCCHN patients, including HPV negative oropharyngeal cancer (OPC) patients and heavy smokers, face a poor prognosis even with current standard of care (SOC) as more than half of them will relapse.3-6 The consequences of LA-SCCHN have a heavy impact on quality of life and social interactions, affecting how patients look, talk, eat and breathe.7-9 Additional therapies are needed to ensure better outcomes for patients facing this devastating condition.

About Debio 1143
Debio 1143 is a potential first-in-class oral antagonist of IAPs (inhibitor of apoptosis proteins), that sensitizes tumor cells to radio-chemo therapy by promoting programmed cell death and fostering anti-tumor immunity. The clinical benefit observed in LA-SCCHN patients suggests that the integration of Debio 1143 into widely used CRT regimens is a promising investigational approach over a broad range of cancer types. Currently poised to enter into a Phase III, pivotal trial later this year in combination with CRT in Head & Neck cancer, the compound is also being investigated along with immune checkpoint inhibitors (PD-1/PD-L1) in various solid tumors. Over 200 patients have been treated so far with Debio 1143 in various indications and lines of treatment, showing an adequate and consistent safety profile across studies.

Debiopharm’s commitment to cancer patients
Debiopharm aims to develop innovative therapies that target high unmet medical needs in oncology. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.
For more information, please visit www.debiopharm.com
We are on Twitter. Follow us @DebiopharmNews at View Source

On February 27, 2020 Mylan N.V. (NASDAQ: MYL) reported its financial results for the fourth quarter and the year ended December 31, 2019 and provided 2020 guidance (Press release, Mylan, FEB 27, 2020, View Source [SID1234554939]).

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Fourth Quarter 2019 Financial Highlights

Total revenues of $3.19 billion, up 4%, up 5% on a constant currency basis, compared to the prior year period.
Revenue Highlights:
Rest of World segment net sales of $927.9 million, up 9%, on an actual and constant currency basis.
Europe segment net sales of $1.11 billion, up 2%, up 5% on a constant currency basis.
North America segment net sales of $1.13 billion, up 3%, on an actual and constant currency basis, primarily due to new products sales.
U.S. GAAP diluted earnings per ordinary share ("U.S. GAAP EPS") of $0.04, compared to U.S. GAAP EPS of $0.10 in the prior year period.
Adjusted diluted earnings per ordinary share ("adjusted EPS") of $1.40, up 8% compared to adjusted EPS of $1.30 in the prior year period.
U.S. GAAP net cash provided by operating activities of $686.7 million, up 8% compared to $636.1 million in the prior year period.
Adjusted free cash flow of $810.5 million, up 18% compared to $689.7 million in the prior year period.
Full Year 2019 Financial Highlights

Total revenues of $11.50 billion, up 1%, up 3% on a constant currency basis, compared to the prior year period.
Revenue Highlights:
Rest of World segment net sales of $3.17 billion, up 5%, up 8% on a constant currency basis.
Europe segment net sales of $4.04 billion, down 3%, up 2% on a constant currency basis.
North America segment net sales of $4.16 billion, up 2%, on an actual and constant currency basis, primarily due to new product sales.
U.S. GAAP EPS of $0.03, compared to $0.68 in the prior year period.
Adjusted EPS of $4.42, down 3%, or flat to the prior year at $4.58 on a constant currency basis.
U.S. GAAP net cash provided by operating activities of $1.80 billion, down 23% compared to $2.34 billion in the prior year period.
Adjusted free cash flow of $2.10 billion, down 22% compared to $2.71 billion in the prior year period, driven by investment in working capital to support the $1.0 billion in new product launches.
Mylan is not providing forward-looking guidance for U.S. GAAP reported financial measures or a quantitative reconciliation of forward-looking non-GAAP financial measures. Please see "Non-GAAP Financial Measures" for additional information.

Full Year 2020 Guidance Highlights

Total Revenues between $11.5 billion and $12.5 billion.
Adjusted EBITDA between $3.2 billion and $3.9 billion.
A reconciliation of the Company’s 2020 financial guidance for Total Revenues and Adjusted EBITDA to the 2020 financial targets provided in July 2019 is presented below.
($ in millions)

Mylan CEO Heather Bresch said: "Mylan’s 2019 full year and fourth quarter results demonstrate the durability and strength of the business model we have created as well as our continued long-term commitment to expand access to medicine. Our model continues to be best positioned to withstand the negative trends impacting the industry, and allowed us to deliver on every key metric we set out to achieve in 2019, including total revenue, revenue from new product launches, and both adjusted cash flow and EPS. Our performance is the result of a number of key milestones, including growth across all segments in the fourth quarter and for the year on a constant currency basis.

Bresch continued: "Looking ahead to the full year of 2020, although we widened the ranges to take into consideration certain factors, the mid-point of our guidance is in line with what we previously disclosed for 2020 in conjunction with the Upjohn transaction. We are extremely proud of the efforts of our global work force that enable us to sustain consistent business performance and profitability across all of our segments. This includes work on our business transformation, which as we’ve previously shared, is focused on unlocking latent value within the organization and delivering economic profit, while maintaining our commitment of providing access."

Bresch continued: "As we have previously stated, on a go-forward basis, we believe adjusted EBITDA to be the best measure of our company’s underlying operational results and true business performance. As we continue to make excellent progress on the path to close the combination with Pfizer’s Upjohn business, we are confident that the strength of our diverse portfolio, geographic reach and global commercial and operational scale will serve as a strong foundation for Viatris to become a new champion for global health."

Mylan President Rajiv Malik said: "Our full-year results also reflect solid underlying business performance driven by existing products that generated double-digit-growth, including Creon, Influvac, Dona, Amitiza and Glatiramer Acetate 40 mg, coupled with achieving our target of $1 billion in new product launch revenues. As we look forward, complex products, global key brands and biosimilars, in addition to our business transformation will enable us to deliver on our 2020 guidance and help position Viatris for a strong future."

Mylan CFO Ken Parks added: "In 2019, Mylan’s stable and durable cash flow profile continued to generate strong results, delivering $2.1 billion of adjusted free cash flow, which was in line with our guidance range for the full year. In addition, we delivered on our commitment to repay $1.1 billion of debt in 2019 and reduced our notional debt to adjusted EBITDA leverage ratio to 3.6 times at the end of the year. In 2020, we remain committed to delever and to maintain our investment grade credit rating by paying down an additional $1 billion of debt on anticipated consistent free cash flow generation, while preserving our financial flexibility."

Evaluation of Financial Performance Measures

The Company’s management team recently undertook an evaluation of how it would measure the financial performance of the Company going forward. In evaluating its financial performance measures, the Company considered the strategy related to the planned 2020 closing of the Upjohn transaction (which will include a transition away from growth by acquisition with a greater focus on complex product related development activity and a focus on capital allocation, including strengthening of the balance sheet through the paydown of debt and returning value to shareholders). The purpose of the evaluation was to identify performance measures that best reflect the Company’s future business operations, strategy and goals. As a result of that evaluation, management identified the following primary financial performance measures for the Company: GAAP Revenues (measure for both guidance and actual results), GAAP Net Income (measure for actual results), Adjusted EBITDA (non-GAAP) (measure for both guidance and actual results) and Adjusted Net Income (measure for actual results).

The Company believes that these measures most appropriately reflect how the Company will evaluate business performance internally and have been used to set operational goals in 2020. In addition, the Company believes that adjusted EBITDA (non-GAAP) focuses management on the Company’s underlying operational results and true business performance, as well as demonstrating the Company’s ability to comply with financial debt covenants and assess the Company’s ability to incur additional indebtedness. As such, adjusted EBITDA will be used starting in 2020, in part, for management’s annual incentive compensation. The Company also believes that GAAP revenue focuses management on the overall growth of the business.

(1) Amounts exclude intersegment revenue that eliminates on a consolidated basis.

(2) Non-GAAP financial measures. Please see "Non-GAAP Financial Measures" for additional information.

Fourth Quarter 2019 Financial Results

Total revenues for the three months ended December 31, 2019 were $3.19 billion, compared to $3.08 billion for the comparable prior year period, representing an increase of $113.1 million, or 4%. Total revenues include both net sales and other revenues from third parties. Net sales for the current quarter were $3.16 billion, compared to $3.04 billion for the comparable prior year period, representing an increase of $127.8 million, or 4%. Other revenues for the current quarter were $28.5 million, compared to $43.2 million for the comparable prior year period.

The increase in net sales included an increase in the North America segment of 3%, in the Europe segment of 2% and in the Rest of World segment of 9%. Mylan’s net sales were unfavorably impacted by the effect of foreign currency translation, primarily reflecting changes in the U.S. Dollar as compared to the currencies of Mylan’s subsidiaries in the European Union. The unfavorable impact of foreign currency translation on current period net sales was approximately $34.9 million, or 1%. On a constant currency basis, net sales increased by approximately $162.7 million, or 5%. This increase was primarily driven by new product sales, partially offset by a decrease in net sales from existing products primarily due to the impact of lower pricing across the regions. Below is a summary of net sales in each of our segments for the three months ended December 31, 2019:

Net sales from North America segment totaled $1.13 billion in the current quarter, an increase of $32.0 million or 3% when compared to the prior year period. This increase was primarily driven by new product sales partially offset by a decline in sales of existing products due to lower volumes, and to a lesser extent lower pricing. New product sales were primarily driven by sales of the Wixela Inhub and other new products. The lower sales of existing products was due to changes in the competitive environment, including the loss of exclusivity of tadalafil. The impact of foreign currency translation on current period net sales was insignificant within North America.

Net sales from Europe segment totaled $1.11 billion in the current quarter, an increase of $19.3 million or 2% when compared to the prior year period. The increase was primarily the result of new product sales and higher volumes of existing products. These items were partially offset by the unfavorable impact of foreign currency translation and lower pricing on existing products. The unfavorable impact of foreign currency translation on the current period was approximately $33.4 million, or 3%. Constant currency net sales increased by approximately $52.7 million, or 5% when compared to the prior year.

Net sales from Rest of World segment totaled $927.9 million in the current quarter, an increase of $76.5 million or 9% when compared to the prior year period. This increase was primarily driven by higher volumes of existing products sold in certain emerging markets, China and Japan and new product sales primarily in Australia, India and certain emerging markets. The increase in net sales was partially offset by lower pricing on existing products and, to a lesser extent, the unfavorable impact of foreign currency translation. The unfavorable impact of foreign currency translation was $1.5 million, or less than 1%. Constant currency net sales increased by approximately $78.0 million, or 9% when compared to the prior year.
U.S. GAAP gross profit for the three months ended December 31, 2019 was $1.09 billion and U.S. GAAP gross margins were 34%. For the three months ended December 31, 2018, U.S. GAAP gross profit was $1.02 billion and U.S. GAAP gross margins were 33%. U.S. GAAP gross margins were positively impacted by approximately 425 basis points due to new product introductions primarily in North America. Additionally, U.S. GAAP gross margins were also positively impacted by a decrease in amortization expense in the quarter. Partially offsetting these items, U.S. GAAP gross margins were negatively impacted by the decline in sales of existing products by approximately 660 basis points. The decline in sales of existing products was primarily in North America. Adjusted gross profit was $1.70 billion and adjusted gross margins were 53% for the three months ended December 31, 2019 compared to adjusted gross profit of $1.68 billion and adjusted gross margins of 55% in the prior year period. Adjusted gross margins were negatively impacted by lower gross profit from sales of existing products partially offset by gross margins on new product introductions primarily in North America.

R&D expense for the three months ended December 31, 2019 was $151.8 million, compared to $148.8 million for the comparable prior year period, an increase of $3.0 million. This increase was primarily due to higher payments in the current year period related to licensing arrangements for products in development partially offset by lower expenditures related to the reprioritization of global programs.

SG&A expense for the three months ended December 31, 2019 was $654.4 million, compared to $632.9 million for the comparable prior year period, an increase of $21.5 million. The increase was primarily due to continued investment in selling and marketing activities. Also contributing to the increase were higher consulting fees and other expenses primarily related to the pending Upjohn transaction totaling approximately $29.0 million in the current quarter. Partially offsetting these items were gains recognized through the sale of assets and a reduction in bad debt expense due to a special business interruption event for one customer realized in the prior year quarter.

During the fourth quarter of December 31, 2019, the Company recorded a net charge of $8.9 million in litigation settlements and other contingencies, net, compared to a net charge of $1.1 million in the comparable prior year period. The increase from the comparable prior year period primarily relates to an increase in fair value of contingent consideration totaling approximately $8.5 million.

U.S. GAAP net earnings decreased by $30.7 million to earnings of $20.5 million for the three months ended December 31, 2019, compared to earnings of $51.2 million for the prior year period and U.S. GAAP EPS decreased from $0.10 in the prior year period to $0.04 in the current quarter. The Company recognized a U.S. GAAP income tax provision of $114.7 million in the current year period, compared to a U.S. GAAP income tax provision of $25.8 million for the comparable prior year period, an increase of $88.9 million. The increase in the U.S. GAAP income tax provision in the current year period is the result of an increase in earnings before taxes as compared to the prior year period combined with increases in the Company’s reserve for uncertain tax provisions in the current quarter. Adjusted net earnings increased by $51.7 million to $721.4 million as compared to $669.7 million for the prior year period. Adjusted EPS increased to $1.40 from $1.30 in the prior year period.

EBITDA was $827.4 million for the current quarter and $841.2 million for the comparable prior year period. After adjusting for certain items as further detailed in the reconciliation below, adjusted EBITDA was $1.06 billion for the current quarter and $1.01 billion for the comparable prior year period.

Year Ended December 31, 2019 Financial Results

For the year ended December 31, 2019, Mylan reported total revenues of $11.50 billion, compared to $11.43 billion for the prior year period, representing an increase of $66.6 million, or 1%. Total revenues include both net sales and other revenues from third parties. Net sales for the year ended December 31, 2019 were $11.37 billion, compared to $11.27 billion for the prior year period, representing an increase of $101.6 million, or 1%. Other revenues for the year ended December 31, 2019 were $130.2 million, compared to $165.2 million for the prior year period, a decrease of $35.0 million.

The increase in net sales was primarily the result of an increase in net sales in the Rest of World segment of 5% and the North America segment of 2%, partially offset by a decrease in the Europe segment of 3%. Mylan’s net sales were unfavorably impacted by the effect of foreign currency translation, primarily reflecting changes in the U.S. Dollar as compared to the currencies of Mylan’s subsidiaries in the European Union, Australia and India. The unfavorable impact of foreign currency translation on current year net sales was approximately $322.4 million, or 3%. On a constant currency basis, the increase in net sales was approximately $424.0 million, or 4% for the year ended December 31, 2019. This increase was driven by new product sales, partially offset by a decrease in net sales from existing products as a result of lower pricing and volumes. Below is a summary of net sales in each of our segments for the year ended December 31, 2019.

Net sales in the North America segment totaled $4.16 billion, an increase of $68.5 million or 2% from the prior year. This increase was due primarily to new product sales, including the Wixela Inhub, Fulphila (biosimilar to Neulasta) and YUPELRI. This increase was partially offset by lower volumes, and to a lesser extent, pricing of existing products, driven by changes in the competitive environment and continued portfolio rationalization. The impact of foreign currency translation on current period net sales was insignificant within North America.

Net sales in the Europe segment totaled $4.04 billion, a decrease of $120.2 million or 3% from the prior year. This decrease was the result of the unfavorable impact of foreign currency translation of approximately $223.7 million, or 5%. Partially offsetting this decrease were new product sales and higher net sales of existing products which were driven by higher volumes partially offset by lower pricing. Constant currency net sales increased by approximately $103.5 million, or 2% when compared to the prior year.

Net sales in the Rest of World segment totaled $3.17 billion, an increase of $153.3 million or 5% from the prior year. This increase was the result of higher net sales of existing products and new product sales. The increase to net sales of existing products was driven by higher volumes primarily in China, Japan, certain emerging markets and from the Company’s ARV franchise. The increase in net sales as a result of new products was primarily due to new product sales in Australia, certain emerging markets and from the Company’s ARV franchise. The increase in net sales was partially offset by the unfavorable impact of foreign currency translation of $93.3 million, or 3%, and to a lesser extent by lower pricing on existing products. Constant currency net sales increased by approximately $246.6 million, or 8%.
U.S. GAAP gross profit for the year ended December 31, 2019 was $3.90 billion and gross margins were 34%. For the year ended December 31, 2018, gross profit was $4.00 billion and gross margins were 35%. Gross margins were negatively impacted by the decline in sales of existing products by approximately 550 basis points. The decline in sales of existing products was primarily in North America and includes the impacts of product rationalization. Partially offsetting this impact, gross margins were positively impacted by approximately 500 basis points due to new product introductions primarily in North America. Adjusted gross profit was $6.14 billion and adjusted gross margins were approximately 53% for the year ended December 31, 2019, compared to adjusted gross profit of $6.18 billion and adjusted gross margins of approximately 54% for the year ended December 31, 2018. Adjusted gross margins were negatively impacted by lower gross profit from sales of existing products partially offset by gross margins on new product introductions primarily in North America.

R&D expense for the year ended December 31, 2019 was $639.9 million, compared to $704.5 million for the prior year, a decrease of $64.6 million. This decrease was primarily due to lower expenditures related to the reprioritization of global programs and lower restructuring related costs.

SG&A expense for the year ended December 31, 2019 was $2.56 billion, compared to $2.44 billion for the prior year, an increase of $122.6 million. The increase was primarily due to an increase of approximately $82.5 million for consulting fees and other expenses primarily related to the pending Upjohn transaction in addition to increased investment in selling and marketing activities. Also contributing to the increase was higher share-based compensation expense of approximately $60.7 million as a result of the reversal of all of the cumulative expense related to certain performance-based awards totaling $70.6 million in the prior year. Partially offsetting these increases was bad debt expense of approximately $26.5 million incurred in the prior year related to a special business interruption event for one customer and $20.0 million of compensation expense for an additional discretionary bonus for a certain group of employees in the prior year. None of the employees who received the 2018 discretionary bonus were named executive officers.

During the year ended December 31, 2019, the Company recorded a net gain of $21.4 million in Litigation settlements and other contingencies, net, compared to $49.5 million in the prior year. During the year ended December 31, 2019, the Company recognized a net gain in litigation settlements of approximately $1.0 million. This net gain was primarily due to a favorable litigation settlement related to the Celgene Corporation matter of $62.0 million, which was partially offset by litigation related charges for settlements reached during the year. Charges for litigation related matters included $18.0 million for the modafinil antitrust matter and $30.0 million for the settlement with the SEC. In addition, a $20.4 million gain was recognized for the reduction of contingent consideration related to the acquisition of the exclusive worldwide rights to develop, manufacture and commercialize a generic equivalent to GlaxoSmithKline’s Advair Diskus incorporating Pfizer’s respiratory delivery platform.

Litigation settlements for the year ended December 31, 2018 consisted primarily of a gain of approximately $22.9 million related to a favorable litigation settlement, which was partially offset by litigation related charges of approximately $14.9 million related to an antitrust and a patent infringement matter. In addition, a $44.0 million gain was recognized for the change in value of contingent consideration related to the respiratory delivery platform, which was partially offset by losses incurred on other contingent consideration.

U.S. GAAP net earnings decreased by $335.7 million to $16.8 million for the year ended December 31, 2019, compared to $352.5 million for the prior year. U.S. GAAP EPS decreased from $0.68 to $0.03 in the current year. The Company recognized an income tax provision of $137.6 million in the current year, compared to an income tax benefit of $54.1 million for the prior year period. During the year ended December 31, 2019, the Company reached an agreement in principle with the IRS to resolve all issues relating to our positions on the EPD Business Acquisition. As a result, the Company recorded a reserve of approximately $155.0 million as part of its liability for uncertain tax positions, with a net impact to the income tax provision of approximately $144.9 million. The tax provision for the year ended December 31, 2018 included a net benefit to the income tax provision of approximately $53.0 million as a result of the federal and state audits and settlements and expirations of certain state, federal, and foreign statutes of limitations. Partially offsetting this benefit was an increase in the reserve for uncertain tax benefits of approximately $18.0 million for certain other matters. Also impacting the current and prior year income tax provision and benefit, respectively, was the changing mix of income earned in jurisdictions with differing tax rates. Adjusted net earnings decreased to $2.28 billion in the current year from $2.36 billion in the prior year and adjusted EPS decreased to $4.42 in the current year from $4.58 in the prior year.

EBITDA was $2.75 billion for the year ended December 31, 2019, and $3.03 billion for the prior year period. After adjusting for certain items as further detailed in the reconciliation below, adjusted EBITDA was $3.54 billion for the year ended December 31, 2019 and $3.62 billion for the prior year period.

Cash Flow

U.S. GAAP net cash provided by operating activities was $1.80 billion for the year ended December 31, 2019 compared to $2.34 billion for the prior year period. Capital expenditures were approximately $213.2 million for the year ended December 31, 2019 compared to approximately $252.1 million for the comparable prior year. Adjusted net cash provided by operating activities was $2.29 billion for the year ended December 31, 2019 compared to $2.97 billion for the prior year period. Adjusted free cash flow, defined as adjusted net cash provided by operating activities less capital expenditures, was $2.10 billion for the year ended December 31, 2019, compared to $2.71 billion in the prior year period.

Guidance

Mylan is providing guidance for 2020 excluding any impact of the proposed combination with the Upjohn business. Mylan expects 2020 total revenues in the range of $11.50 billion to $12.50 billion, the midpoint of which represents an increase of 4% versus 2019. Adjusted EBITDA is expected to be in the range of $3.2 billion to $3.9 billion, which is in line with 2019 at the midpoint.

As discussed in the "Non-GAAP Financial Measures" section below, other than revenues, Mylan is not providing forward looking guidance for U.S. GAAP reported financial measures or a quantitative reconciliation of forward-looking non-GAAP financial measures to the most directly comparable U.S. GAAP measure because it is unable to predict with reasonable certainty the ultimate outcome of certain significant items without unreasonable effort. These items include, but are not limited to, acquisition-related expenses, including integration, restructuring expenses, asset impairments, litigation settlements and other contingencies, including changes to contingent consideration and certain other gains or losses. These items are uncertain, depend on various factors, and could have a material impact on U.S. GAAP reported results for the guidance period.

Q4 2019 Earnings Call and 2020 Guidance

As previously announced, Mylan N.V. will host a webcast at 4:30 p.m. ET today to discuss the Company’s financial results for the fourth quarter and year ended December 31, 2019, along with financial guidance for 2020. The webcast can be accessed live by calling 855.493.3607 or 346.354.0950 for international callers (ID#: 9599904) or at the following address on the Company’s website: investor.mylan.com. The "Q4 2019 Earnings Call & 2020 Guidance" presentation, which will be referenced during the call can be found at investor.mylan.com. A replay of the webcast also will be available on the website.