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Medicure Reports Financial Results for Quarter Ended September 30, 2019

On November 26, 2019 Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH, OTC:MCUJF), a cardiovascular pharmaceutical company, reported its results from operations for the quarter ended September 30, 2019 (Press release, Medicure, NOV 26, 2019, View Source [SID1234551730]).

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Quarter Ended September 30, 2019 Highlights:

Recorded net revenue from the sale of AGGRASTAT (tirofiban hydrochloride) of $5.3 million during the quarter ended September 30, 2019 compared to $7.0 million for the quarter ended September 30, 2018;

$35.7 million in cash as at September 30, 2019;

Adjusted earnings before interest, taxes, depreciation and amortization (EBITDA1) for the quarter ended September 30, 2019 was negative $319,000 compared to adjusted EBITDA of $599,000 for the quarter ended September 30, 2018; and

Net loss for the quarter ended September 30, 2019 was $599,000 compared to net loss of $545,000 for the quarter ended September 30, 2018.
Financial Results

Net revenues for the three months ended September 30, 2019 were $5.5 million compared to $7.4 million for the three months ended September 30, 2018. Net revenues from AGGRASTAT for the three months ended September 30, 2019 were $5.3 million compared to $7.0 million for the three months ended September 30, 2018. Additionally, ReDSTM, contributed $117,000 of net revenue for the three months ended September 30, 2019 and ZYPITAMAGTM contributed $78,000 compared to $326,000 during the three months ended September 30, 2018 following the launch of the product in 2018.

Net revenues for the nine months ended September 30, 2019 were $16.7 million compared to $21.2 million for the nine months ended September 30, 2018. Net revenues from AGGRASTAT for the nine months ended September 30, 2019 were $16.3 million compared to $20.3 million for the nine months ended September 30, 2018. Additionally, ReDSTM contributed $272,000 and ZYPITAMAGTM contributed $87,000 of net revenue for the nine months ended September 30, 2019. The nine months ended September 30, 2018 contained $932,000 of revenue from ZYPITAMAGTM following the launch of the product in 2018.

The Company continued to experience strong patient market share and strong hospital demand for AGGRASTAT during the three and nine months ended September 30, 2019, however this was offset by increased price competition that resulted in lower discounted prices for AGGRASTAT throughout the quarter.

Diversification of revenues remains an important aspect of the Company’s focus with Medicure concentrating on the sales and marketing of AGGRASTAT, growing the sales of ZYPITAMAGTM (pitavastatin) and marketing the ReDSTM system.

Adjusted EBITDA for the three months ended September 30, 2019 was negative $319,000 compared to $599,000 for the three months ended September 30, 2018. The decrease in adjusted EBITDA for the three months ended September 30, 2019 is the result of the lower revenues experienced during the quarter ended September 30, 2019.

Adjusted EBITDA for the nine months ended September 30, 2019 was negative $1.9 million compared to $2.5 million for the nine months ended September 30, 2018. The decrease in adjusted EBITDA for the nine months ended September 30, 2019 is the result of lower revenues experienced during the nine months ended September 30, 2019.

Net loss for the three months ended September 30, 2019 was $599,000 or $0.04 per share. This compares to net loss of $545,000 or $0.03 per share for the three months ended September 30, 2018. Net loss for the three months ended September 30, 2019 is the result of lower revenues experienced during the quarter and a write-down of expiring ZYPITAMAGTM inventory of $578,000 partially offset by a foreign exchange gain relating to an increase in the value of the U.S. dollar experienced during the quarter ended September 30, 2019.

Net loss for the nine months ended September 30, 2019 was $4.3 million or $0.28 per share. This compares to net income of $2.4 million or $0.15 per share for the nine months ended September 30, 2018. Net loss for the nine months ended September 30, 2019 is the result of lower revenues, experienced during the period, a write-down of expiring ZYPITAMAGTM inventory of $578,000 and a foreign exchange loss relating to a decrease in the value of the U.S. dollar experienced during the nine months ended September 30, 2019.

At September 30, 2019, the Company had unrestricted cash totaling $35.7 million compared to $71.9 million of cash and short-term investments as of December 31, 2018. The decrease in cash is primarily due to the investment of U.S. $10 million made in Sensible Medical Innovations Ltd., the acquisition of full ZYPITAMAGTM rights acquired during the third quarter for US$5 million and the purchase of $4.1 million of the Company’s common shares under its normal course issuer bid, a significant reduction in the Company’s accounts payable and accrued liabilities and a decrease in the value of the U.S. dollar as at September 30, 2019 compared to December 31, 2018. Cash flows used in operating activities for the nine months ended September 30, 2019 totaled $10.9 million.

All amounts referenced herein are in Canadian dollars unless otherwise noted.

Notes

(1) The Company defines EBITDA as "earnings before interest, taxes, depreciation, amortization and other income or expense" and Adjusted EBITDA as "EBITDA adjusted for non-cash and non-recurring items, including the write-down of inventory". The terms "EBITDA" and "Adjusted EBITDA", as it relates to the three and nine months ended September 30, 2019 and 2018 results prepared using International Financial Reporting Standards ("IFRS"), do not have any standardized meaning according to IFRS. It is therefore unlikely to be comparable to similar measures presented by other companies.

Conference Call Info:

Topic: Medicure’s Q3 2019 Results

Call date: Wednesday, November 27, 2019

Time: 7:30 AM Central Time (8:30 AM Eastern Time)

Canada toll-free: 1 (888) 465-5079 Canada toll: 1 (416) 216-4169

United States toll-free: 1 (888) 545-0687

Passcode: 7343307#

Webcast: This conference call will be webcast live over the internet and can be accessed from the Medicure investor relations page at the following link: View Source

You may request international country-specific access information by e-mailing the Company in advance. Management will accept and answer questions related to the financial results and operations during the question-and-answer period at the end of the conference call. A recording of the call will be available following the event at the Company’s website.

Innovent Announces First Patient Dosed in Phase I Clinical Trial of Anti-PD-1/HER2 Bispecific Antibody in China

On November 26, 2019 Innovent Biologics, Inc. ("Innovent" or "the Company") (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, reported with Beijing Hanmi Pharmaceutical Co., Ltd. (a subsidiary of Hanmi Pharmaceutical Co., Ltd.) ("Hanmi") that the first patient has been successfully dosed in a Phase I clinical trial (CIBI315A101) of a recombinant fully human bispecific antibody targeting programmed cell death receptor-1 (PD-1) and human epidermal growth factor receptor 2 (HER2) (IBI315), an innovative antibody co-developed by both companies (Press release, Innovent Biologics, NOV 26, 2019, View Source [SID1234551729]).

CIBI315A101 is a phase I clinical trial conducted in China to evaluate the safety, tolerability, initial efficacy and recommended Phase II dose ("RP2D") of IBI315 in the treatment of patients with HER2-expressing advanced solid malignancies, either as monotherapy or in combination with chemotherapy.

IBI315 is a recombinant fully human IgG1 bispecific antibody targeting PD-1 and HER2, which may offer a novel solution to treat HER2-expressing malignancies. IBI315 can simultaneously block the PD-1/PD-L1 signaling pathway, the HER2 signaling pathway, and bridge PD-1-expressing T cells to HER2-expressing tumor cells. IBI315 combines both the targeted therapy and the immunotherapy mechanisms of action, thereby potentially enhancing anti-tumor activity and increasing anti-tumor efficacy.

Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent, said: "IBI315, as one of our pivotal drug candidates in our pipeline of cancer immunotherapies, is the world’s first PD-1/HER2 bispecific antibody that has entered clinical development. The development of IBI315 is therefore highly valuable and we hope that this new therapeutic bispecific antibody will offer a novel and more effective solution to patients’ unmet medical needs and ultimately benefit more patients."

Mr. Se Chang Kwon, CEO of Hanmi Pharmaceutical, said: "The new drug candidate developed upon Hanmi’s PENTAMBODYTM bispecific platform technology has successfully entered into clinical stage. We will continue to cooperate closely with our partner Innovent to focus on our R&D to further advance clinical and commercial development."

About IBI315

IBI315 is developed through the collaboration between Innovent and Hanmi, and Innovent is leading its clinical development in China. IBI315 is a recombinant fully human IgG1 bispecific antibody targeting PD-1 and HER2 simultaneously. Preclinical studies have shown that the bridging effects between T cells and tumor cells introduced by IBI315 may enhance anti-tumor activity.

About CIBI315A101

CIBI315A101 is a phase I clinical trial conducted in China to evaluate IBI315 in the treatment of patients with HER2-expressing advanced solid malignancies. The primary objectives of this study are safety, tolerability, initial efficacy and recommended Phase II dose ("RP2D") of IBI315, either as monotherapy or in combination with chemotherapy.

Exelixis Announces Webcasts of Investor Conference Presentations in December

On November 26, 2019 Exelixis, Inc. (Nasdaq: EXEL) reported that members of Exelixis’ management team will provide an overview of the company at the following investor conferences in December (Press release, Exelixis, NOV 26, 2019, View Source [SID1234551728]):

Evercore ISI 2nd Annual HealthCONx: Exelixis is scheduled to present at 8:45 AM EST / 5:45 AM PST on Tuesday, December 3, 2019 in Boston.
Piper Jaffray 31st Annual Healthcare Conference: Exelixis is scheduled to present at 10:00 AM EST / 7:00 AM PST on Tuesday, December 3, 2019 in New York.
To access the webcast links, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to listen to the webcasts. Replays will also be available at the same location for 14 days.

X4 Pharmaceuticals Prices $65 Million Public Offering of Common Stock and Class B Warrants

On November 26, 2019 X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics for the treatment of rare diseases, reported the pricing of its previously announced underwritten public offering of 3,666,667 shares of its common stock and, in lieu of common stock, pre-funded warrants to purchase 1,750,000 shares of common stock, and accompanying Class B warrants to purchase 5,416,667 shares of its common stock (or, for investors who so choose, pre-funded warrants to purchase shares of common stock) at a price to the public of $12.00 per share and accompanying Class B warrant (or $11.999 per pre-funded warrant and accompanying Class B warrant) (Press release, X4 Pharmaceuticals, NOV 26, 2019, View Source [SID1234551727]). X4’s gross proceeds from this offering are expected to be approximately $65.0 million, before deducting underwriting discounts and estimated offering expenses. All of the securities in the offering are being sold by X4. The offering is expected to close on or about November 29, 2019, subject to customary closing conditions.

Cowen and Stifel are acting as joint book-running managers for the offering. Canaccord Genuity and Oppenheimer & Co. are acting as lead managers, and H.C. Wainwright & Co. and Roth Capital Partners are acting as managers for the offering.

The offering is being made only by means of a written prospectus and related prospectus supplement forming part of a shelf registration statement on Form S-3 that was originally filed with the Securities and Exchange Commission (SEC) on August 9, 2019 and declared effective by the SEC on August 29, 2019. The preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering were filed with the SEC on November 25, 2019. The final prospectus supplement and accompanying prospectus will be filed with the SEC and will be available at the SEC’s website located at www.sec.gov, copies of which may be obtained, when available, from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926, and from Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, or by telephone at 415-364-2720 or by email at [email protected].

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

Sensei Biotherapeutics to Present at the 31st Annual Piper Jaffray Healthcare Conference

On November 26, 2019 Sensei Biotherapeutics, Inc., a clinical-stage biopharmaceutical company developing precision immuno-oncology therapies, reported that John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics, will present a company overview at the 31st Annual Piper Jaffray Healthcare Conference on Tuesday, December 3, 2019 at 2:50 p.m. ET in New York, NY (Press release, Sensei Biotherapeutics, NOV 26, 2019, View Source [SID1234551726]).