On February 26, 2019 On February 26, 2019, Ultragenyx Pharmaceutical Inc. ("we," "Ultragenyx" or the "Company")reported that it has entered into an underwriting agreement (the "Underwriting Agreement") with J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC, Merrill Lynch, Pierce, Fenner & Smith Incorporated, and Cowen and Company, LLC (the "Underwriters"), providing for the offer and sale in an underwritten public offering (the "Offering") of 5,072,464 shares of the Company’s common stock, par value $0.001 per share (the "Common Stock"), at a public offering price of $60.00 per share, to be purchased by the Underwriters from us at a price of $56.70 per share. Pursuant to the Underwriting Agreement, the Company granted the Underwriters a 30-day option (the "Option") to purchase up to an additional 760,869 shares of Common Stock on the same terms (Filing, 8-K, Ultragenyx Pharmaceutical, FEB 26, 2019, View Source [SID1234533869]). On February 27, 2019, the Underwriters exercised the Option in full.

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The Offering closed on March 1, 2019. In the Underwriting Agreement, the Company agreed to indemnify the Underwriters against certain liabilities, including liabilities under the Securities Act of 1933, as amended, or to contribute to payments that the Underwriters may be required to make because of such liabilities.

We estimate that the net proceeds we will receive from the Offering will be approximately $330.4 million, after deducting the Underwriters’ discounts and commissions and estimated offering expenses payable by us.

The Offering was made under a prospectus supplement and related prospectus filed with the Securities and Exchange Commission pursuant to the Company’s automatically effective shelf registration statement on Form S-3 (Registration No. 333-223123). The Offering was not registered under any state blue sky laws.

On February 26, 2019 Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for LN-145 for the treatment of patients with recurrent, metastatic or persistent cervical cancer who have progressed while on or after chemotherapy (Press release, Iovance Biotherapeutics, FEB 26, 2019, View Source;p=RssLanding&cat=news&id=2389051 [SID1234533762]). LN-145 is the Company’s adoptive cell therapy produced using its proprietary TIL manufacturing technology.

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"We are pleased to have received Fast Track designation for LN-145 for the treatment of cervical cancer in patients who have failed chemotherapy treatment," commented Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance Biotherapeutics. "The designation is an important positive step for the development of LN-145 in a serious and unmet medical need patient population. We are excited about the clinical data for LN-145 in cervical cancer patients and look forward to a closer collaboration with the FDA as we advance the clinical development of LN-145 for the treatment of cervical cancer."

The Fast Track designation from the FDA is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need, which includes providing a therapy that may be potentially better than the available ones. With the Fast Track designation for LN-145, Iovance is expected to have more frequent meetings and communication with the FDA and is eligible, if relevant criteria are met upon submission, for a Rolling Review of the Biologic License Application (BLA) and potentially Accelerated Approval.1

The Company had previously reported preliminary data from the Phase 2 study of LN-145 for cervical cancer (C-145-04) in October 2018 for 15 patients yielding an overall response rate (ORR) of 27%. Patients in the study had a median of five prior therapies. The most common treatment-emergent adverse events included chills, pyrexia and anaemia. The protocol for the cervical cancer study has since been amended to limit the number of prior therapies to no more than three and to exclude patients who have been treated with prior immunotherapy. The study is actively recruiting patients at 32 clinical sites in the United States and Europe. The company anticipates providing an update on this study at an upcoming medical meeting in 2019.

On February 26, 2019 Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, reported the pricing of its underwritten public offering of 5,072,464 shares of its common stock at a price to the public of $60.00 per share resulting in gross proceeds of $304.3 million, before underwriting discounts (Press release, Ultragenyx Pharmaceutical, FEB 26, 2019, View Source [SID1234533760]). In addition, the company has granted the underwriters of the offering an option for a period of 30 days to purchase up to an additional 760,869 shares of the company’s common stock at the public offering price, less the underwriting discount.

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The offering is expected to close on or about March 1, 2019, subject to satisfaction of customary closing conditions. J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC, BofA Merrill Lynch, and Cowen are acting as joint book-running managers for the offering.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission and became automatically effective on February 21, 2018. This offering is being made solely by means of prospectus supplement and accompanying prospectus. When available, copies of the final prospectus supplement and the accompanying prospectus related to the offering may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at 866-803-9204, or by email at prospectus- [email protected]; Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing [email protected]; BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at [email protected]; and Cowen, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY, 11717, United States, Attn.: Prospectus Department or by telephone 1-631-274-2806.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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 26, 2019 Coherus BioSciences, Inc. (Nasdaq: CHRS), reported that senior management will present at two upcoming investor healthcare conferences (Press release, Coherus Biosciences, FEB 26, 2019, View Source [SID1234533743]).

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Management will deliver a company presentation at the 38thCowen & Company Healthcare Conference on Tuesday, March 12th at 10 a.m. ET taking place in Boston, Massachusetts.
Management will deliver a company presentation at Barclays Global Healthcare Conference on Wednesday, March 13th at 8:00 a.m. ET taking place in Miami, Florida.
The audio portion of the presentations will be available on the investors page of the Coherus BioSciences website at View Source

On February 26, 2019 Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported record financial results for the fourth quarter and full year 2018 and associated Company developments (Press release, Supernus, FEB 26, 2019, View Source [SID1234533734]).

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Commercial Update

Fourth quarter 2018 product prescriptions for Trokendi XR and Oxtellar XR, as reported by IQVIA, totaled 209,901, a 16.7% increase over the fourth quarter of 2017. Full year 2018 product prescriptions for Trokendi XR and Oxtellar XR, as reported by IQVIA, totaled 786,411, a 29.1% increase over full year 2017.

"We reported another year of strong operating results in 2018, driven by continued double-digit prescription growth for both Trokendi XR and Oxtellar XR," said Jack Khattar, President and CEO of Supernus Pharmaceuticals. "In addition, we recently reached a key milestone by launching Oxtellar XR, in January 2019, with an expanded indication to include monotherapy for partial seizures, which could be a meaningful long term growth opportunity."

Progress of Product Pipeline

SPN-812 — Novel non-stimulant for the treatment of ADHD

· During December 2018, the Company announced positive topline results from the two pediatric Phase III trials (P301 and P303) and from the first adolescent Phase III trial (P302). All three trials met the primary endpoint with robust statistical significance. Topline data from the second and final adolescent Phase III trial (P304) are expected by the end of the first quarter of 2019.

· The Company continues to expect to submit a New Drug Application (NDA) for SPN-812 in the second half of 2019, and to launch it, pending U.S. Food and Drug Administration (FDA) approval, in the second half of 2020.

·A Phase III program in adult patients is anticipated to start in the second half of 2019.

SPN-810 — Novel treatment of Impulsive Aggression in patients with ADHD

· Enrollment in the Phase III trials (P301 and P302) continues with data from both trials expected in the second half of 2019.

· The Company continues to expect to submit an NDA for SPN-810 in the second half of 2020, and to launch it, pending FDA approval, in the second half of 2021.

· Enrollment in the Open Label Extension (OLE) study continues at 90% or higher. On average, a patient in the OLE study remains on SPN-810 treatment for approximately 10 months, which we believe is an encouraging sign of the tolerability and efficacy of SPN-810.

· Patient dosing continues in the Phase III trial (P503) in adolescent patients.

SPN-604 — Novel treatment of bipolar disorder

· The Company expects to start pivotal Phase III studies for the treatment of bipolar disorder in the second half of 2019.

"We made significant progress in 2018 advancing our late-stage programs through clinical development, including announcing positive topline results from three Phase III trials for SPN-812 for treatment of ADHD," said Jack Khattar. "We are focused in 2019 on submitting the NDA for SPN-812 and completing the Phase III trials for SPN-810, moving us closer to our goal of

delivering, in the next several years, two novel products, both addressing billion-dollar market opportunities. In addition, we look forward to starting another Phase III program this year, with SPN-604 for the treatment of bipolar disorder."

Operating Expenses

Fourth Quarter

Research and development expenses in the fourth quarter of 2018 were $29.8 million, as compared to $16.2 million in the same quarter last year. This increase was primarily due to the one-time upfront expense of approximately $14 million in the fourth quarter of 2018 for the acquisition of Biscayne Neurotherapeutics, Inc. (Biscayne).

Selling, general and administrative expenses in the fourth quarter of 2018 were $42.1 million, as compared to $33.8 million in the same quarter last year. This increase was primarily due to the development and production of promotional materials and marketing programs associated with the launch of the monotherapy indication for Oxtellar XR, and an increase in share-based compensation expense.

Full Year

Research and development expenses for the full year 2018 were $89.2 million, as compared to $49.6 million for 2017. This increase was primarily due to the initiation of the four Phase III clinical trials for SPN-812 in the second half of 2017, the OLE trials for SPN-812 and SPN-810, and the one-time upfront expense of approximately $14 million for the acquisition of Biscayne.

Selling, general and administrative expenses for full year 2018 were $159.9 million, as compared to $137.9 million in 2017. This increase was primarily due to the expansion of the salesforce by 40 salespeople, who were fully deployed in the fourth quarter of 2017, increased marketing spend to support Trokendi XR, as well as the factors impacting the fourth quarter as described above.

Operating Earnings and Earnings Per Share

Operating earnings in the fourth quarter of 2018 were $39.9 million, a 16% increase over $34.3 million in the same period the prior year. Operating earnings in full year 2018 were $144.4 million, a 45.1% increase over $99.5 million in 2017. The improvement in operating earnings in both periods was primarily due to increased net product sales, offset by the aforementioned one-time upfront expense of approximately $14 million for the acquisition of Biscayne.

Net earnings (GAAP) in the fourth quarter of 2018 were $25.9 million, or $0.48 per diluted share, an increase of 85% on diluted share amount, as compared to $13.7 million, or $0.26 per diluted share, in the same period last year. Net earnings (GAAP) were $111.0 million in 2018, or $2.05 per diluted share, an increase of 90% on diluted share amount, as compared to $57.3 million, or $1.08 per diluted share, in 2017. In addition to higher operating income for the fourth quarter and full year 2018, net earnings (GAAP) benefited from the reduction in the statutory U.S. Federal income tax rate and, to a lesser extent, from stock option exercises. The reduction in income tax rate had an unfavorable impact of $9.7 million in both the fourth quarter and full year 2017.

Weighted-average diluted common shares outstanding were approximately 54.1 million in the fourth quarter and full year 2018, as compared to approximately 53.5 million and 53.3 million in each of the respective prior year periods.

Balance Sheet Highlights

As of December 31, 2018, the Company had $774.8 million in cash, cash equivalents, marketable securities, and long term marketable securities, compared to $273.7 million at December 31, 2017. This increase reflects net proceeds of $364.9 million from the issuance of convertible senior notes and warrants in March 2018, partially offset by purchases of convertible note hedges, the aforementioned one-time upfront payment of $15 million for the acquisition of Biscayne, and increased cash from operations in 2018.

Financial Guidance

For full year 2019, the Company estimates net product sales, research and development expenses, operating earnings, and an effective tax rate as set forth below. This guidance assumes that the short-term higher levels of wholesaler and pharmacy channel inventory experienced in the fourth quarter of 2018 will revert to historical levels in 2019.

· Net product sales in the range of $435 million to $455 million. Guidance reflects the Company’s expectation that wholesaler and pharmacy channel inventory levels will revert to historical 2018 levels, thereby affecting 2019 net product sales by approximately $10 million.

· Research and development expenses in the range of $70 million to $80 million.

· Operating earnings in the range of $160 million to $180 million.

· Effective tax rate of approximately 23% to 25%.

Investor Day

The Company is pleased to announce that it will hold an Investor Day in New York City on April 16, 2019. The management team plans to provide an overview of the Company including a detailed discussion on its clinical programs and an assessment of the associated market opportunities.

Conference Call Details

The Company will hold a conference call hosted by Jack Khattar, President and Chief Executive Officer, and Greg Patrick, Senior Vice President and Chief Financial Officer, to discuss these results at 9:00 a.m. Eastern Time, on Wednesday, February 27, 2019. An accompanying webcast also will be provided.

Please refer to the information below for conference call dial-in information and webcast registration. Callers should dial in approximately 10 minutes prior to the start of the call.

Conference dial-in:

(877) 288-1043

International dial-in:

(970) 315-0267

Conference ID:

2170478

Conference Call Name:

Supernus Pharmaceuticals Fourth Quarter and Full Year 2018 Earnings Conference Call

Following the live call, a replay will be available on the Company’s website, www.supernus.com, under "Investor Relations".