QIAGEN increases outlook for 2020 and 2021

On December 8, 2020 QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported that it has raised its full-year 2020 outlook for growth of net sales and adjusted earnings per share (EPS) and is looking forward to another strong performance in 2021 (Press release, Qiagen, DEC 8, 2020, View Source [SID1234572444]).

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These results are expected to be driven by QIAGEN’s focus on five pillars of growth that leverage differentiated testing solutions used in highly attractive, growing markets involving Life Sciences and Molecular Diagnostics customers.

"2020 has demonstrated QIAGEN employees worldwide stepping up to deal with demanding changes. We have responded to the demands of the COVID-19 pandemic by launching novel testing solutions and ramping up production capacity," said Thierry Bernard, Chief Executive Officer of QIAGEN N.V. "As we finish 2020 with an improved outlook, we have confidence in our future and in the benefits of our unwavering focus on our five pillars of growth. We expect another strong performance in 2021, balancing investments in our portfolio to create new organic long-term growth opportunities with improved near-term earnings to deliver significant value creation."

Roland Sackers, Chief Financial Officer of QIAGEN N.V., said: "QIAGEN has developed a solid foundation for continued financial success. This is reflected in our solid outlook for 2020 and 2021, along with expectations for double-digit CER net sales growth post-COVID from our non-COVID products. We have also reaffirmed our disciplined capital allocation strategy, anchored by our commitment to invest in our business and increase returns to shareholders."

Additionally, QIAGEN announced today that its Supervisory Board plans to expand the number of members from the current level of six. The Board intends to further diversify, complement and increase its already extensive expertise and experience in the Life Sciences and diagnostics.

QIAGEN is planning to hold a Virtual Deep Dive on Tuesday, December 8, from 16:30-19:00 CET / 10:30-13:00 EST. This webcast will feature top executives and be led by Thierry Bernard and Roland Sackers, who will provide a strategic and financial update. More details about the event are available via the Investor Relations section on www.qiagen.com.

Increased outlook for Q4 2020, full-year 2020 and full-year 2021 results

QIAGEN now expects net sales for the fourth quarter of 2020 to grow at least 32% at constant exchange rates (CER) from $413.5 million in the same period of 2019, and for adjusted EPS to increase to approximately $0.64-0.65 CER from $0.48 in the year-ago quarter.

QIAGEN also now expects full-year 2020 net sales to grow approximately 22% CER from $1.53 billion in 2019, and for adjusted EPS to increase to $2.13-2.14 CER from $1.43 in 2019.

These strong trends are expected to continue into 2021. QIAGEN now expects full-year 2021 net sales to grow 18-20% CER from the midpoint of the anticipated range for full-year 2020 net sales results. Adjusted EPS is now expected to be $2.42-2.46 CER. These results include significant investments planned for R&D and clinical trials to strengthen the competitive profile of QIAGEN’s five pillars of growth. In particular, these include initiatives to enlarge the test menu for the NeuMoDx and QIAstat-Dx systems in the U.S. and Europe.

QIAGEN plans to maintain or take a top leadership position in these areas identified as the five pillars of growth: (1) Sample technologies used to gain nucleic acids from biological samples; (2) QuantiFERON for immune response testing, especially tuberculosis (TB); (3) the integrated PCR system NeuMoDx; (4) the QIAstat-Dx syndromic testing solution; and (5) the QIAcuity digital PCR portfolio.

Delcath Systems Announces Proposed Public Offering of Common Stock

On December 8, 2020 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of rare primary and metastatic cancers of the liver, reported that it intends to offer and sell, subject to market conditions, shares of its common stock in an underwritten public offering (Press release, Delcath Systems, DEC 8, 2020, View Source [SID1234572443]). All of the shares of common stock to be sold in the offering will be offered by Delcath. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Delcath also expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares sold in the public offering.

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Delcath intends to use the net proceeds from this offering for (i) the completion of its FOCUS Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma (the "Focus Trial"), a global registration clinical trial that is investigating the primary endpoint of objective response rate, as well as other secondary and exploratory endpoints, in metastatic ocular melanoma, or mOM; (ii) preparation of the federal regulatory application for the HEPZATO KIT (melphalan hydrochloride for injection/hepatic delivery system), or HEPZATO, a drug/device combination product regulated as a drug, designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects; (iii) preparation for the commercial launch of HEPZATO; (iv) continued clinical development, including additional indications and expanded access trials in metastatic ocular melanoma; and (v) general corporate purposes, which may include capital expenditures and other operating expenses.

Canaccord Genuity and Roth Capital Partners are acting as joint book-running managers for the proposed offering.

A shelf registration statement relating to these securities has been filed with the U.S. Securities and Exchange Commission (SEC) and became effective on December 21, 2018. The offering is being made only by means of a preliminary prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement, which will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, by contacting Canaccord Genuity LLC, Attention: Syndicate Department, 99 High Street, Suite 1200, Boston, MA 02110, by telephone at (617) 371-3900 or by email at [email protected] or Roth Capital Partners, LLC, 888 San Clemente, Newport Beach, CA 92660, Attention: Prospectus Department, or by telephone at (800) 678-9147.

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 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.

Syros Closes $90.5 Million Strategic Financing

On December 8, 2020 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that it has closed a previously announced private financing with a group of institutional accredited investors led by Bain Capital Life Sciences, with participation from new and existing investors, including Ally Bridge Group, Omega Funds, OrbiMed Advisors, EcoR1 Capital, and Samsara BioCapital (Press release, Syros Pharmaceuticals, DEC 8, 2020, View Source [SID1234572442]).

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In this financing, Syros sold an aggregate of 10,312,500 shares of its common stock and pre-funded warrants (Pre-Funded Warrants) to purchase an aggregate of 1,000,000 shares of common stock, and accompanying warrants (Warrants) to purchase an aggregate of up to 2,828,125 additional shares of common stock (or Pre-Funded Warrants in lieu thereof) at a price of $8.00 per share and accompanying Warrant (or $7.99 per Pre-Funded Warrant and accompanying Warrant). The price per Pre-Funded Warrant and accompanying Warrant represents the price of $8.00 per share and accompanying Warrant to be sold in the private placement, minus the $0.01 per share exercise price of each such Pre-Funded Warrant. The exercise price of the Warrants is $11.00 per share, or if exercised for a Pre-Funded Warrant in lieu thereof, $10.99 per Pre-Funded Warrant (representing the Warrant exercise price of $11.00 per share minus the $0.01 per share exercise price of each such Pre-Funded Warrant). The Warrants are exercisable at any time during the period beginning on June 8, 2021 and ending on December 8, 2025. The Pre-Funded Warrants are exercisable at any time after their original issuance and will not expire. The gross proceeds from the sales of common stock and Pre-Funded Warrants are $90.5 million, before deducting offering expenses.

Net proceeds from this financing are expected to be used to advance Syros’ clinical development pipeline, business development activities, working capital and other general corporate purposes.

The securities sold in the private placement have not been registered under the Securities Act of 1933, as amended (Securities Act), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. The Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission registering the resale of the shares of common stock issued and sold in the private placement no later than the 30th day after the closing of the offering. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

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

Forma Therapeutics Launches Proposed Public Offering

On December 8, 2020 Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, reported that it has launched a proposed public offering of 4,600,000 shares of its common stock (Press release, Forma Therapeutics, DEC 8, 2020, View Source [SID1234572441]).

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All of the shares of common stock in the offering will be offered by Forma. In addition, Forma expects to grant the underwriters a 30-day option to purchase up to 690,000 additional shares of common stock. Together with its existing cash and cash equivalents, Forma intends to use the net proceeds of the offering for (i) the development of its lead program FT-4202 in sickle cell disease including completion of its ongoing Phase 1 clinical trial and, subject to the results of its Phase 1 clinical trial, the initiation and conduct of its planned, global pivotal Phase 2/3 clinical trial through Phase 3 dose selection and hemoglobin futility and hemoglobin improvement, the initiation and conduct of a clinical trial in pediatric sickle cell disease and the initiation and conduct of a clinical trial in beta thalassemia through an initial data readout; (ii) the advancement of FT-7051 in metastatic castration-resistant prostate cancer, through its planned Phase 1 clinical trial; and (iii) research and development, working capital, and general corporate purposes, including funding pre-approval activities for FT-2102 in acute myeloid leukemia and the completion of other noncore programs. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the proposed offering.

Jefferies, SVB Leerink and Credit Suisse are acting as joint book-running managers for the offering.

A registration statement relating to these securities has been filed with the U.S. Securities and Exchange Commission (the "SEC") but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any offer or sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

The proposed offering will be made only by means of a prospectus. When available, copies of the preliminary prospectus may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by email at [email protected]; or Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by email at [email protected].

Curis Announces Proposed Public Offering of Common Stock

On December 8, 2020 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported its intention to offer and sell shares of its common stock in an underwritten public offering pursuant to an existing shelf registration statement (Press release, Curis, DEC 8, 2020, View Source [SID1234572440]). Curis intends to grant the underwriters a 30-day option to purchase additional shares in an amount of up to 15% of the shares sold in the public offering, on the same terms and conditions.

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Cantor Fitzgerald & Co. and JonesTrading Institutional Services LLC are acting as joint lead book runners.

Curis intends to use the net proceeds from the public offering, together with its existing cash and cash equivalents, to continue development of CA-4948, in collaboration with Aurigene, and CI-8893, in collaboration with ImmuNext, and for general working capital and capital expenditures.

The securities in the public offering described above are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-224627) that was filed with the United States Securities and Exchange Commission ("SEC") on May 3, 2018, and declared effective by the SEC on May 17, 2018. The offering can be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus may also be obtained by contacting Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022 or by email at [email protected].

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