On January 23, 2019 Philogen S.p.A. (a privately-owned company) reported that they have entered into a collaboration and license agreement with Celgene, to discover and develop a new class of immunomodulatory therapeutics (Press release, Philogen, JAN 23, 2019, View Source [SID1234532836]).

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"We are extremely pleased to establish a new collaboration with Celgene, a leader in the discovery and development and commercialization of innovative therapies for patients with high unmet medical needs," commented Dr. Duccio Neri, Philogen’s CEO.

On January 23, 2019 PTC Therapeutics, Inc. (Nasdaq: PTCT) reported the pricing of a public offering of 6,720,000 shares of its common stock at a public offering price of $30.20 per share, before underwriting discounts (Press release, PTC Therapeutics, JAN 23, 2019, View Source [SID1234532837]). All of the shares in the offering are to be sold by PTC. In addition, PTC has granted the underwriter an option for a period of 30 days to purchase up to an additional 1,008,000 shares of common stock at the public offering price, less the underwriting discount.

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RBC Capital Markets is acting as the sole book-running manager for the offering.

PTC expects to close the offering on or about January 25, 2019, subject to satisfaction of customary closing conditions.

An automatically effective shelf registration statement on Form S-3 relating to the shares of common stock offered in the public offering has been filed with the Securities and Exchange Commission (the "SEC") and is available on the SEC’s website at www.sec.gov. A final prospectus supplement relating to and describing the terms of the offering also will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Before investing in the offering, interested parties should read the prospectus supplement and the accompanying prospectus for the offering and the other documents PTC has filed with the SEC that are incorporated by reference in the prospectus supplement and the accompanying prospectus, which provide more complete information about PTC and the offering. Copies of the prospectus supplement and the accompanying prospectus relating to the offering may be obtained from: RBC Capital Markets, LLC, Attention: Equity Syndicate, 200 Vesey Street, 8th Floor, New York, NY 10281; telephone: (877) 822-4089; email: [email protected].

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 the registration or qualification under the securities laws of such state or jurisdiction.

On January 23, 2019 Varian (NYSE: VAR) reported its first quarter fiscal year 2019 results (Filing, 8-K, Varian Medical Systems, JAN 23, 2019, View Source [SID1234532877]). All comparisons in this announcement are year-over-year, all quarter and year references are fiscal unless noted otherwise, and any references to orders are gross orders.

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(1)Non-GAAP net earnings and Non-GAAP net earnings per diluted share are defined as GAAP net earnings and GAAP net earnings per diluted share adjusted to exclude the amortization of intangible assets, acquisition-related expenses and benefits, significant litigation charges or benefits and legal costs, significant non-recurring tax expense or benefit, and gains or losses on equity investments.

"In the first quarter, we built on the strong trajectory from last year, bringing our trailing twelve-month orders growth rate to 11%," said Dow Wilson, chief executive officer of Varian. "The team delivered exceptional performance, with accelerating software revenues and overall orders growing double-digits in each of our three geographic regions. We made progress on our strategic growth initiatives, extending our global footprint by securing Halcyon approval in China and expanding our addressable markets by signing two Noona deals with pharmaceutical companies. With a strong start to the year and tariff mitigation activities on track, we are well-positioned to deliver results within our fiscal year 2019 guidance."

The company ended the quarter with $616 million in cash and cash equivalents and no debt. Net cash provided by operating activities was $141 million, down 21% due to timing of certain accounts receivable collections and inventory build to meet demand. During the quarter, the company invested $35 million to repurchase 320,000 shares of common stock.

Oncology Systems Segment

In the first quarter, Oncology revenues totaled $702 million, up 8%. Operating earnings for the segment decreased 10%, primarily driven by the impact of tariffs.

Orders were $716 million, up 16%. Orders in the Americas increased 12%. In EMEA, orders rose 15%, the sixth consecutive quarter of double-digit growth for the region. In APAC, orders increased 25%, with accelerating growth in China.

Proton Solutions Segment

In the first quarter, Proton Solutions revenues totaled $39 million, up 32%. The company completed clinical handovers for one room each at three sites.

Non-GAAP Adjustments

Varian’s GAAP operating earnings include $22 million from the gain on the sale of the company’s equity investment in Augmenix, Inc. The company also incurred $2 million in acquisition-related expenses.

Guidance for Full Fiscal Year 2019

We are reaffirming the following guidance for fiscal year 2019:

•Revenue range of $3.06 billion to $3.15 billion, representing growth of 5% to 8%
•Non-GAAP operating earnings as a percentage of revenues range of 17.0% to 18.0%
•Non-GAAP net earnings per diluted share range of $4.60 to $4.75
•Cash flows from operations range of $460 million to $510 million

The guidance assumes a Non-GAAP effective tax rate of 21% to 22% and a weighted average diluted share count of 92 million. The guidance also assumes currency rates as of the beginning of fiscal year 2019, includes the expected net impact of all tariffs effective as of the beginning of the fiscal year, and excludes any future acquisitions.

Please refer to "Discussion of Non-GAAP Financial Measures" below for a description of items excluded from expected non-GAAP earnings.

Investor Conference Call

Varian Medical Systems is scheduled to conduct its first quarter fiscal year 2019 conference call at 1:30 p.m. Pacific Time today. To access the live webcast or replay of the call, visit the Investor Relations page on our website at www.varian.com/investors. To access the call via telephone, dial 1-877-869-3847 from inside the U.S. or 1-201-689-8261 from outside the U.S. The replay can be accessed by dialing 1-877-660-6853 from inside the U.S. or 1-201-612-7415 from outside the U.S. and entering conference ID 13685671. The teleconference replay will be available through 5:00 p.m. Pacific Time, Friday, January 25, 2019.

On January 23, 2019 ProMIS Neurosciences Inc. ("ProMIS" or the "Company") (TSX: PMN); (OTCQB:ARFXF) is reported that it has closed a private placement of 9,560,000 units (the "Units") at a price of CDN$0.23 (or US$0.173) per Unit (the "Offering Price") for gross proceeds of approximately CDN$2,198,800 (the "Offering") (Press release, ProMIS Neurosciences, JAN 23, 2019, View Source [SID1234532827]).

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"We are pleased with the completion of this private placement", stated Dr. Elliot Goldstein, ProMIS President and CEO. "The additional funds allow us to capitalize on the continued interest we are seeing from large pharma in our programs targeting toxic forms of alpha-synuclein for Parkinson’s disease (PD) and TDP43 for ALS (amyotrophic lateral sclerosis). ProMIS will continue to generate data showing the high degree of selectivity and competitive advantages of ProMIS novel antibody programs with a view to accelerate a possible partnering deal for our PD and ALS assets."

Each Unit consisted of one common share of the Company (each a "Share") and one share purchase warrant of the Company (each a "Warrant"). Each Warrant will entitle the holder thereof to purchase one Share ("a "Warrant Share") at an exercise price of $0.48 per Warrant Share at any time for five years following the closing date of the Offering (the "Closing Date"). The expiry date of the Warrants is subject to acceleration such that if following the four month anniversary of the Closing Date, the twenty-day volume-weighted average trading price ("20 day VWAP") of the Shares on the TSX is greater than $1.00, or the Company enters into a partnering deal within 18 months of the closing of the Offering with minimum proceeds of US$5 million and the 20 day VWAP is greater than $0.48 at any time following the announcement of such a partnering deal. The Company may accelerate the expiry date of the Warrants by issuing a press release announcing the reduced warrant term whereupon the Warrants will expire on a day that is not less than 30 calendar day after the date of such press release.

In connection with the Offering, the Company paid to qualified finders a cash commission in the aggregate amount of $39,445 (the "Finder’s Fee") equal to 7% of the gross proceeds from the sale of Units to purchasers introduced by such finders. The Company also issued a total of 164,500 finder’s warrants (the "Finder’s Warrants") equal to 7% of the number of Units sold to purchasers introduced by such finders. The Finder’s Warrants will have the same terms as the Warrants that form part of the Offering.

All securities issued in connection with the Offering will be subject to a statutory hold period expiring on May 23, 2019 in accordance with applicable securities laws. Net proceeds from the Offering are intended to be used for working capital and general corporate purposes.

Closing of the Offering is subject to customary conditions, including TSX final approval. The Offering was offered to qualified investors in the provinces of Alberta, British Columbia and Ontario, and otherwise in those jurisdictions where the Offering can lawfully be made including the United States under applicable private placement exemptions.

Three insiders of the Company subscribed for an aggregate of 556,214 units, which constitutes a "related party transaction" within the meaning of Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions ("MI 61-101"). The issuances to the insiders are exempt from the formal valuation and the minority shareholder approval requirements of MI 61-101 as the fair market value of the units issued to or the consideration paid by such person did not exceed 25% of the Company’s market capitalization.

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 the securities in any state in which such offer, solicitation or sale would be unlawful. The securities issued, or to be issued, under the Offering have not been, and will not be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements

On January 22, 2019 Klaria AB (Klaria) (Parent Company, Klaria Pharma Holding AB, Stockholm OMX Nasdaq:KLAR) and Purdue Pharma (Canada) reported they have entered into an exclusive development agreement for KL-01401 (Epinephrine Oromucosal Film) (Press release, Purdue Pharma, JAN 22, 2019, View Source;license-and-supply-agreements-with-purdue-pharma–canada–for-th,c2724247 [SID1234553985]). KL-01401 is a developmental stage formulation of epinephrine for emergency treatment of severe anaphylactic reactions in patients who are at increased risk for anaphylaxis. KL-01401 will be co-developed by Klaria and Purdue Pharma (Canada). The development agreement includes exclusive global license and supply options for the independently associated Purdue/Napp/Mundipharma network of companies upon achievement of defined milestones.

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Under the terms of the agreement, the total value of all milestones achievable is 55.2 million US Dollars. In addition, Klaria will receive mid-to-upper single digit royalties on net sales. Further terms of the agreements give Klaria exclusive manufacturing rights to supply the global market with KL-01401.

In order to complete the agreement with Purdue, Klaria AB has also added epinephrine to its license agreement with Uppsalagruppen Medical AB. In the agreement between Klaria and Uppsalagruppen, Uppsalagruppen will receive a four precent royalty on Klaria’s net income from sales of KL-01401.

KL-01401 is based on Klaria’s novel patented drug delivery platform, which provides several benefits to patients who may require emergency treatment, for anaphylactic reactions. It is planned as an easy to use, non-injectable self-administered treatment that allows patients and their caregivers to discreetly carry a life-saving emergency treatment medication with them at all times.

Dr. Scott Boyer, CEO, Klaria commented: "We are extremely pleased and encouraged to enter into this agreement with Purdue – our second collaboration to date. This agreement combines the strengths of our patented drug delivery platform with a partner who is a leader in development and commercialization of innovative treatments. We are confident that the result of our partnership will meet an unmet medical need for patients relying on epinephrine in the event of a severe allergic reaction."

David Pidduck, President and CEO of Purdue Pharma (Canada) commented:"Today’s agreement signals an exciting move for Purdue as we endeavour to shift the treatment paradigm for Canadians living with the threat of an anaphylactic reaction. Anaphylaxis is the most serious type of allergic reaction and current treatment options continue to face increasing challenges, including availability. The deepening of our partnership with Klaria by entering into a second development agreement with them is another example of our commitment to investing in new technologies and treatment options that will make a positive impact on the healthcare system and on patients’ lives. This agreement is consistent with our overall strategy of expanding opportunities through business development."