Mundipharma launches Pelmeg®▼(pegfilgrastim) biosimilar in Europe

On February 5, 2019 The Mundipharma network of independent associated companies reported the launch of Pelmeg (pegfilgrastim), a biosimilar of Neulasta following European Commission (EC) approval in November 2018 (Press release, Mundipharma, FEB 5, 2019, View Source [SID1234533075]).2 Pelmeg is the fourth biosimilar medicine to be commercialised by Mundipharma, expanding its portfolio and commercial footprint across Europe. It was developed by Cinfa Biotech which was acquired by Mundipharma and announced in October 2018.

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Now available in Germany, the Netherlands and Ireland, Pelmeg is indicated for the reduction of the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).1

"We are delighted that Pelmeg is now available in these countries. The launch of the treatment builds on our proven commercial excellence in biosimilars over the past four years. Pelmeg has the potential to play an important role in improving the lives of patients affected by chemotherapy induced neutropenia and febrile neutropenia," said Philippe Bastide, Head of Biosimilars, Europe. "Through our partnership with Celltrion, we estimate Remsima and Truxima have already saved European healthcare systems approximately €330m.3* If all patients currently being treated with the reference product are offered access to Pelmeg, further significant savings can be realised for the healthcare community."

The acquisition of Cinfa Biotech provides Mundipharma with global reach and expanded development capabilities. Mundipharma will continue to leverage partnerships to develop its expanding portfolio of Biosimilars, reinforcing its leadership in Europe and extending its geographical footprint.

*Figures relate to data from 2015-2017

Notes to editors

About the clinical data

A comprehensive analytical, biofunctional, preclinical and clinical comparability programme has demonstrated a high degree of similarity between Pelmeg and Neulasta.4 Its biosimilarity has been studied in healthy volunteers who have no comorbidities, require no co-medication and are immunocompetent.5,6,7

The data:

Confirmed biosimilarity to Neulasta in sensitive clinical study settings
Demonstrated pharmacokinetic comparability to Neulasta at the clinical dose of 6 mg
Demonstrated pharmacodynamic comparability to Neulasta at the clinical dose of 6 mg and at the reduced dose of 3 mg
Did not show any clinically meaningful differences in the safety and immunogenicity profile compared to Neulasta
About Pelmeg

It is a pegfilgrastim biosimilar.1 Pegfilgrastim is a pegylated version of granulocyte-colony stimulating factor (G-CSF) that works by stimulating the bone marrow to produce more neutrophils, thereby reducing the duration of neutropenia and the incidence of febrile neutropenia. It is administered as a subcutaneous injection once per chemotherapy cycle, at least 24 hours after cytotoxic chemotherapy.1

The approval of Pelmeg was based on a robust regulatory submission of rigorous analytical, biofunctional, preclinical and clinical studies to demonstrate biosimilarity in terms of its quality, safety and efficacy profile compared with the reference pegfilgrastim.4 As such, it is indicated in the exact same way as subcutaneous (pre-filled syringe) Neulasta.

Most standard-dose chemotherapy regimens are associated with 6–8 days of neutropenia, and febrile neutropenia is observed in approximately 8 cases per 1000 patients receiving cancer chemotherapy. People with febrile neutropenia caused by chemotherapy treatment for cancer are at increased risk of severe infection and death.8

About neutropenia and febrile neutropenia

People taking chemotherapy for cancer are at risk of dangerously low levels of a type of white blood cell called a neutrophil. Neutrophils play an important role in the immune system guarding against infection. Febrile neutropenia is a low level of neutrophils in the blood accompanied by a fever.9

Exicure Announces US Clinical Sites for Phase 1b/2 Oncology Trial

On February 5, 2019 Exicure, Inc. (OTCQB: XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported four of the clinical trial sites for the Company’s Phase 1b/2 trial of AST-008 (Press release, Exicure, FEB 5, 2019, View Source [SID1234533074]).

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"Exicure is thrilled to announce the four initial sites for the Phase 1b/2 clinical trial to evaluate our immune system activating spherical nucleic acid in combination with Keytruda for the treatment of solid tumors," said Dr. David Giljohann, Chief Executive Officer of Exicure. "We are encouraged by the results of our Phase 1 clinical trial, which demonstrated that our drug is well-tolerated and activates key immune cells and signals. Eligible patients will be able to enroll in trial sites in the US."

The open-label Phase 1b/2 trial will begin with a dose finding Phase 1b stage in combination with the anti-PD-1 therapy pembrolizumab (KEYTRUDA), followed by a Phase 2 expansion stage. In the Phase 1b, Exicure will enroll patients with superficial injectable tumors and will prioritize those with Merkel cell carcinoma, cutaneous squamous cell carcinoma, melanoma, and squamous cell carcinoma of the head and neck. Preliminary data from the Phase 1b stage of the trial are expected in late 2019.

The clinical trial sites are as follows:

Dana Farber Cancer Institute (Boston, Massachusetts)
Holden Comprehensive Cancer Center at the University of Iowa (Iowa City, Iowa)
John Wayne Cancer Institute at Providence St. John’s Health Center (Santa Monica, California)
Sylvester Comprehensive Cancer Center at the University of Miami (Miami, Florida)
AST-008 is a toll-like receptor nine (TLR9) activator being developed by Exicure. More information on the Phase 1b/2 trial of AST-008 can be found at clinicaltrials.gov, under identifier number NCT03684785.

KEYTRUDA (Pembrolizumab; Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.) is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Premier Inc. Reports Fiscal 2019 Second-Quarter Results

On February 5, 2019 Premier Inc. (NASDAQ: PINC) reported financial results for the fiscal 2019 second quarter ended Dec. 31, 2018 (Press release, Premier, FEB 5, 2019, View Source [SID1234533073]).

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The company adopted new revenue recognition standard ASC 606 on July 1, 2018, in conjunction with the beginning of fiscal 2019, using the modified retrospective approach and did not restate prior periods. Therefore, results of operations under the new revenue standard ASC 606 are not indicative of what results of operations were under the previous standard ASC 605. However, for informational purposes, current period results under the previous standard are included in the tables at the back of this press release.

Q2 2019 Highlights:

GAAP net revenue increased to $421.9 million from $411.4 million a year ago; Supply Chain Services segment revenue of $327.0 million increased from $324.9 million a year ago and Performance Services segment revenue of $94.9 million increased from $86.5 million.
GAAP net income of $104.8 million increased from $19.8 million and diluted net income of $0.69 per share compared with $0.06 per diluted share a year ago.
Non-GAAP adjusted EBITDA* increased to $142.0 million from $133.5 million a year ago.
Non-GAAP adjusted fully distributed net income* increased to $88.4 million, representing $0.66 per diluted share, compared with $70.0 million, or $0.50 per diluted share a year ago.
Management reaffirms full-year fiscal 2019 guidance ranges and underlying assumptions.
* Descriptions of non-GAAP financial measures are provided in "Use and Definition of Non-GAAP Financial Measures," and reconciliations are provided in the tables at the end of this release.

"Premier delivered another successful quarter this fiscal year, characterized by steady revenue and earnings growth across our business segments and for the company as a whole," said Susan DeVore, president and chief executive officer. "We finished the quarter with continued strong liquidity, as year-over-year non-GAAP free cash flow increased 29 percent to $114.8 million. We used our strong balance sheet and cash flow to grow our capabilities with the acquisition of Stanson Health Inc., and to return cash to stockholders through our ongoing $250.0 million stock repurchase program.

"Our financial outlook remains consistent with the full-year guidance ranges we discussed last quarter and we are reaffirming these guidance ranges today," DeVore said. "We plan to continue to move forward as a leader of our industry’s transformation to value-based care, expanding and integrating our capabilities and working closely with our member providers to help ensure ongoing success in this rapidly evolving marketplace."

(b) Earnings per share attributable to stockholders excludes the adjustment of redeemable limited partners’ capital to redemption amount and the net income attributable to non-controlling interest in Premier LP if Class B common stock is determined to be dilutive. Likewise, earnings per share attributable to stockholders includes the adjustment of redeemable limited partners’ capital to redemption amount and the net income attributable to non-controlling interest in Premier LP if Class B common stock is determined to be antidilutive. The company has corrected prior period information within the current period financial statements related to a specific component used in calculating the tax effect on Premier Inc. net income for purposes of diluted earnings (loss) per share. Diluted earnings (loss) per share for the three months ended December 31, 2017 was previously stated at ($1.66) per share and has been corrected to $0.06 per share. Diluted earnings (loss) per share for the six months ended December 31, 2017 was previously stated at ($1.30) per share and has been corrected to $0.36 per share. The company believes the correction is immaterial and the amount had no impact on the company’s overall financial condition, results of operations or cash flows.

(c) See attached supplemental financial information for reconciliation of reported GAAP results to Non-GAAP results.

For the fiscal second-quarter ended Dec. 31, 2018, Premier generated GAAP net revenue of $421.9 million, an increase of $10.5 million from net revenue of $411.4 million for the same period a year ago.

GAAP net income for the fiscal second quarter was $104.8 million, compared with $19.8 million a year ago. Year-ago net income was impacted by a decrease in the effective tax rate due to federal tax reform, resulting in a re-measurement of tax receivable agreement liabilities totaling $177.2 million, offset by an increase in tax expense of $221.2 million attributable to the re-measurement of deferred tax balances. This resulted in income tax expense of $231.5 million in the year-ago quarter, compared with $1.8 million in the current quarter. In accordance with GAAP, fiscal 2019 and 2018 second-quarter net income attributable to stockholders included non-cash adjustments of $651.7 million and $317.9 million, respectively, to reflect the change in the redemption value of limited partners’ Class B common unit ownership at the end of each period. These non-cash adjustments result primarily from changes in the number of Class B common units outstanding and the company’s stock price between periods and do not reflect results of the company’s business operations. After these non-cash adjustments, the company reported net income attributable to stockholders of $693.9 million, compared with $281.2 million for the same period a year ago. Second-quarter net income of $0.69 per diluted share compared with $0.06 for the same period a year ago. See "Calculation of GAAP Earnings per Share" in the income statement section of this press release.

Fiscal second-quarter non-GAAP adjusted EBITDA increased to $142.0 million from $133.5 million for the same period the prior year.

Non-GAAP adjusted fully distributed net income for the fiscal second quarter of $88.4 million increased $18.4 million from $70.0 million for the same period a year ago. Non-GAAP adjusted fully distributed earnings per share totaled $0.66, compared with $0.50 for the same period a year ago. Adjusted fully distributed earnings per share is a non-GAAP financial measure that represents net income, adjusted for non-recurring and non-cash items, attributable to all stockholders as if all Class B stockholders exchanged their Class B common units and associated Class B common shares for Class A common shares.

Segment Results

Supply Chain Services
For the fiscal second quarter ended Dec. 31, 2018, Supply Chain Services segment net revenue of $327.0 million increased $2.1 million from $324.9 million a year ago. Net administrative fees revenue of $165.7 million increased by $6.4 million, or 4%, from the prior year primarily driven by further contract penetration of existing members and, to a lesser degree, the impact of conversion of new members. Net administrative fees in the fiscal 2019 second quarter under the previous revenue recognition standard totaled $169.8 million, an increase of 7% over a year ago, reflecting the impact of timing associated with certain cash collections between quarters.

Products revenue of $157.5 million decreased $4.6 million from $162.1 million a year ago. Growth in oncology and respiratory-related drug revenue was offset primarily by the impact of gross to net revenue recognition changes associated with the adoption of ASC 606, which negatively impacted revenue by $11.9 million, and to a lesser extent by reimbursement compression in the integrated pharmacy business.

Supply Chain Services segment non-GAAP adjusted EBITDA for the fiscal 2019 second quarter increased to $134.1 million from $132.0 million for the same period a year ago. Growth in net administrative fees revenue and decreased selling, general and administrative expenses were partially offset by reimbursement compression in the integrated pharmacy business and by increases in certain product-related costs in the direct sourcing business.

Performance Services
For the fiscal second quarter ended Dec. 31, 2018, Performance Services segment net revenue of $94.9 million increased $8.4 million from $86.5 million for the same quarter last year, driven by growth in applied sciences and analytics services as well as by growth in cost management consulting services. Under the new accounting standard, consulting services revenue is now recognized proportionally to when services are provided, and the company generally no longer is required to defer recognition until certain performance conditions are met.

Performance Services segment non-GAAP adjusted EBITDA totaled $37.1 million for the fiscal 2019 second quarter, a $9.2 million increase from $27.9 million for the same quarter last year. The increase was primarily the result of higher revenue partially offset by increases in selling, general and administrative expenses.

Results of Operations for the Six Months Ended Dec. 31, 2018
For the six months ended Dec. 31, 2018, GAAP net revenue increased to $823.4 million from net revenue of $802.0 million for the same period a year ago.

For the six-month period, GAAP net income totaled $186.8 million, compared with $80.4 million for the same period a year ago. Year-ago net income was impacted by a decrease in the effective tax rate due to federal tax reform, resulting in a re-measurement of tax receivable agreement liabilities totaling $177.2 million, offset by an increase in tax expense of $221.2 million attributable to the re-measurement of deferred tax balances. This resulted in income tax expense of $244.3 million in the year-ago quarter, compared with $12.6 million in the current quarter. Fiscal 2019 and 2018 six-month GAAP net income attributable to stockholders required non-cash adjustments of $(56.5) million and $638.3 million, respectively, to reflect changes in redemption value of the limited partners Class B common unit ownership at the end of each period. These non-cash adjustments result primarily from changes in the number of Class B common units outstanding and the company’s stock price between periods and do not reflect results of the company’s business operations. After these non-cash adjustments, the company reported net income attributable to stockholders of $12.6 million compared with $617.6 million a year ago. On a diluted per-share basis, net income totaled $0.22 compared with $0.36 for the same period a year ago. See "Calculation of GAAP Earnings per Share" in the income statement section of this press release.

For the six months ended Dec. 31, 2018, non-GAAP adjusted EBITDA of $280.6 million increased from $252.7 million for the same period last year. Non-GAAP adjusted fully distributed net income of $175.3 million increased from $131.7 million for the same period a year ago, while non-GAAP adjusted fully distributed earnings per share increased to $1.31 from $0.94.

Supply Chain Services segment net revenue for the first six months of fiscal 2019 increased to $642.8 million from $630.7 million a year earlier. Supply Chain Services segment adjusted EBITDA increased to $269.5 million from $257.7 million for the prior year.

Performance Services segment net revenue for the six months of fiscal 2019 increased to $180.6 million from $171.3 million a year earlier. Segment adjusted EBITDA increased to $67.7 million from $49.2 million.

Cash Flows and Liquidity

Net cash provided by operating activities was $212.3 million for the six-month period ended Dec. 31, 2018, compared with $206.5 million for the same period last year. The increase in cash flow from operations was primarily driven by increased net administrative fees and other services and support revenue and decreased cost of services revenue and selling, general and administrative expenses in the current period, partially offset by increased working capital needs. At Dec. 31, 2018, the company’s cash and cash equivalents totaled $110.6 million, compared with $152.4 million at June 30, 2018. At Dec. 31, 2018, the company had an outstanding balance of $100.0 million on its five-year, $1.0 billion revolving credit facility.

Non-GAAP free cash flow for the six-month period ended Dec. 31, 2018 was $116.6 million, compared with $122.2 million for the same period a year ago and was impacted by the $18.0 million TRA payment made to member owners in the current period. Timing of the payment shifted to July in the current year from June in previous years due to a change in the company’s federal tax filing deadline. The company expects free cash flow to exceed 50% of non-GAAP adjusted EBITDA for the full fiscal year. The company defines free cash flow as cash provided by operating activities less quarterly tax distributions and annual TRA payments to limited partners and purchases of property and equipment (see free cash flow reconciliation to net cash provided by operating activities in the tables section of this press release).

Through the close of trading on Dec. 31, 2018, the company repurchased approximately 2.9 million shares of Class A common stock for $109.5 million. The repurchases took place under the company’s ongoing $250.0 million stock repurchase program for fiscal 2019, and had the impact of adding approximately $0.01 to diluted per-share results for the period. The repurchase authorization may be expanded, suspended, delayed or discontinued at any time at the discretion of the Board of Directors.

Fiscal 2019 Outlook and Guidance

Based on results for the six months ended Dec. 31, 2018, management’s current expectations for the remainder of fiscal 2019 and the realization of previously disclosed underlying assumptions, the company reaffirms its full fiscal-year 2019 guidance ranges for consolidated net revenue, non-GAAP Supply Chain Services and Performance Services segment revenue, non-GAAP adjusted EBITDA and non-GAAP adjusted fully distributed earnings per share. Underlying assumptions have not changed with the exception of stock-based compensation expense, which is now estimated in a range of $29 million to $31 million.

* The company does not meaningfully reconcile guidance for non-GAAP adjusted EBITDA and non-GAAP adjusted fully distributed earnings per share to net income attributable to stockholders or earnings per share attributable to stockholders because the company cannot provide guidance for more significant reconciling items between net income attributable to stockholders and adjusted EBITDA and between earnings per share attributable to stockholders and non-GAAP adjusted fully distributed earnings per share without unreasonable effort. This is due to two primary reasons:

• Reasonable guidance cannot be provided for reconciling the adjustment of redeemable limited partners’ capital to redemption amount – historically the largest adjustment in the reconciliation from non-GAAP to GAAP amounts – due to the fact that the increase or decrease in this item is based on the change in the number of Class B common units outstanding and change in stock price between quarters, which the company cannot predict, control or reasonably estimate.

• Reasonable guidance cannot be provided for earnings per share attributable to stockholders because the ongoing quarterly member-owner exchange of Class B common units and corresponding Class B common stock into shares of Class A common stock impacts the number of shares of Class A common stock outstanding each quarter, which the company cannot predict, control or reasonably estimate. Member owners have the right, but not the obligation, to exchange class B common units on a quarterly basis, and the company has the discretion to settle any exchanged units for Class A common stock, cash, or a combination thereof, neither of which can be predicted, controlled or reasonably estimated at this time.

Conference Call

Premier management will host a conference call and live audio webcast on Tuesday, Feb. 5, 2019, at 8:00 a.m. ET, to discuss the company’s financial results. The conference call can be accessed through a link provided on the investor relations page on Premier’s website at investors.premierinc.com. Those wanting to participate by phone may do so by dialing 844.296.7719 and providing the operator with conference ID number: 6890785. International callers should dial 574.990.1041 and provide the same passcode. The company encourages callers to dial in at least five minutes before the start of the call to register. The archived webcast will be accessible on Premier’s investor relations page.

NanOlogy Chief Medical Officer on Panel to Discuss Next Wave of Innovation in IO Therapy at BIO CEO & Investor Conference

On February 5, 2019 NanOlogy, a clinical-stage oncology company, reported its Chief Medical Officer, Gere diZerega, MD, will participate on an immuno-oncology panel at the BIO CEO and Investor Conference February 11, 2019 9:00-9:55 am, Schubert Complex, 6th floor, New York Marriot Marquis (Press release, NanOlogy, FEB 5, 2019, View Source [SID1234533072]).

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The panel, entitled "Reshaping Tumor Microenvironments via Immunotherapies," will examine the next wave of innovation in immunotherapies for leveraging knowledge of how tumor microenvironments develop to create treatments able to demonstrate more durable effects on shrinking tumors across wider ranges of patients.

Based on a proprietary production technology platform, NanOlogy is developing patented submicron particle forms of paclitaxel and docetaxel designed for local delivery directly to the disease site. Preclinical and clinical data across broad therapeutic areas, including genitourinary, gastrointestinal, peritoneal, and lung cancers indicate targeted delivery of the submicron particles of pure drug enhance tumor kill and generate significant immune stimulation with minimal systemic side effects. The data underscore the potential for NanOlogy investigational drugs to be ideal companions to IO therapy for certain solid tumors.

The company is in clinical development of its investigational drugs for prostate cancer, bladder cancer, renal cancer, peritoneal/ovarian cancers, pancreatic cancer, pancreatic mucinous cysts, and lung cancer.

BioSpace recently named NanOlogy to its list of Top 20 Life Sciences companies to watch in 2019.

Joining Dr. diZerega on the panel are: Moderator: Jotin Marango, MD, PhD, Managing Director, Senior Research Analyst, ROTH Capitol; Lewis H. Bender, Chief Executive Officer, Intensity Therapeutics; Sabine Chlosta, MD, PhD, Chief Medical Officer, Triumvira Therapeutics; and Eric Falcand, Vice President of Business Development & Licensing, Servier.

NanOlogy investigational drugs are progressing under the FDA streamlined 505(b) (2) regulatory pathway. The NanOlogy submicron particle technology platform is based on a patented production process that reduces the size of paclitaxel and docetaxel API crystals by up to 400 times into stable submicron particles of pure drug with exponentially increased surface area and unique geometry. The submicron particles are so unique that they are protected under a composition of matter patent (US 9,814,685) valid until 2036, which provides new molecular entity-like advantages without the risks and timeline associated with NME drug development.

OPKO Health, Inc. Announces the Pricing of its Offering of Convertible Senior Notes

On February 5, 2019 OPKO Health, Inc. ("OPKO Health" or the "Company") (NASDAQ: OPK) reported the pricing of its offering of $200 million aggregate principal amount of Convertible Senior Notes due 2025 (the "Notes") (Press release, Opko Health, FEB 5, 2019, View Source [SID1234533071]). The Notes will be general senior unsecured obligations of the Company, will pay interest semiannually in arrears at a rate of 4.50% per annum, and will mature on February 15, 2025, unless earlier repurchased, redeemed or converted. The Notes will be convertible into, at the Company’s election, cash, shares of the Company’s common stock, or a combination of cash and common stock, as further described in the prospectus supplement. The conversion rate for the Notes will initially be 236.7424 shares of common stock per $1,000 principal amount of the Notes, which is equivalent to an initial conversion price of approximately $4.22 per share of common stock, and is subject to adjustment under the terms of the Notes. The Company has granted the underwriter an option to purchase up to an additional $30 million aggregate principal amount of the Notes to cover over-allotments, if any. The sale of the Notes is expected to close on February 7, 2019.

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The Company may not redeem the Notes prior to February 15, 2022, but may redeem the Notes, at its option, on or after February 15, 2022 if the last reported sale price of the Company’s common stock has been at least 130% of the conversion price for the Notes for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period ending on, and including, the trading day immediately preceding the date on which the Company provides notice of redemption. The redemption price will equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.

The Company intends to use the net proceeds received from the offering of the Notes to fund research and development to further develop and commercialize its portfolio of proprietary pharmaceutical and diagnostic products and for working capital, capital expenditures, acquisitions and other general corporate purposes, which will include the repayment or repurchase of indebtedness or debt securities outstanding from time to time, including $28.8 million principal amount and accrued but unpaid interest currently outstanding under the Company’s line of credit with an affiliate of the Company’s Chairman and Chief Executive Officer.

In connection with the Company’s offering of the Notes, the Company has entered into a share lending agreement with an affiliate of Jefferies LLC (the "Share Borrower"), under which it will lend to the Share Borrower a total of up to 30 million shares of the Company’s common stock. The borrowed shares will be newly-issued shares issued in connection with the offering of the Notes and will be cancelled or held as treasury shares upon the expiration or early termination of the share lending agreement.

Purchasers of the Notes may separately sell up to 30 million shares of the Company’s common stock that they may borrow through the Share Borrower. The Company expects that the selling stockholders will use the short position created by such sales to establish their initial hedge with respect to their investments in the Notes. The Company will not receive any proceeds from the sale of the borrowed shares.

Jefferies LLC is acting the sole book-running manager for the offering.

The offering of the Notes and the offering of the Company’s common stock is being made by means of separate prospectus supplements to the prospectus forming a part of the Company’s effective shelf registration statement filed with the Securities and Exchange Commission (the "SEC") on January 28, 2019 and other related documents. You may obtain these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies of the preliminary prospectus supplements may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY, 10022, by email at [email protected] or by phone at +1 877 821 7388. Before you invest, you should read the prospectus supplements and accompanying base prospectus along with other documents that the Company has filed with the SEC for more complete information about the Company and these offerings.

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy, the Notes, the Company’s common stock or any other securities, nor will there be any sale of convertible notes, the Company’s common stock or any other securities in any state or other 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 other jurisdiction.