AbbVie Prices $30 Billion of Senior Unsecured Notes

On November 12, 2019 AbbVie Inc. (NYSE:ABBV) ("AbbVie") reported that it has priced its previously announced private offering (the "Offering") of senior unsecured notes in a combined aggregate principal amount of $30 billion (collectively, the "Notes") (Press release, AbbVie, NOV 12, 2019, View Source [SID1234551010]). The Notes will be issued in ten tranches: (i) $750,000,000 in aggregate principal amount of senior floating rate notes due May 2021, (ii) $750,000,000 in aggregate principal amount of senior floating rate notes due November 2021, (iii) $750,000,000 in aggregate principal amount of senior floating rate notes due 2022, (iv) $1,750,000,000 in aggregate principal amount of 2.150% senior notes due 2021, (v) $3,000,000,000 in aggregate principal amount of 2.300% senior notes due 2022, (vi) $3,750,000,000 in aggregate principal amount of 2.600% senior notes due 2024, (vii) $4,000,000,000 in aggregate principal amount of 2.950% senior notes due 2026, (viii) $5,500,000,000 in aggregate principal amount of 3.200% senior notes due 2029, (ix) $4,000,000,000 in aggregate principal amount of 4.050% senior notes due 2039 and (x) $5,750,000,000 in aggregate principal amount of 4.250% senior notes due 2049. AbbVie expects that the closing of the Offering will occur on November 21, 2019, subject to the satisfaction of customary closing conditions.

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The Offering is being conducted in connection with AbbVie’s previously announced acquisition (the "Acquisition") of Allergan plc ("Allergan"). AbbVie expects to use the net proceeds from the Offering to fund a portion of the aggregate cash consideration due to Allergan shareholders in connection with the Acquisition and to pay related fees and expenses, with any remaining net proceeds being used for general corporate purposes. The Offering is not conditioned upon the consummation of the Acquisition. However, if (i) the Acquisition has not been consummated on or prior to January 30, 2021 or (ii) prior to such date, AbbVie notifies the trustee in respect of the Notes that it will not pursue the consummation of the Acquisition, then AbbVie will be required to redeem all of the Notes then outstanding at a special mandatory redemption price equal to 101% of the aggregate principal amount of the Notes, plus accrued and unpaid interest, if any, to, but not including, the applicable special mandatory redemption date.

The Notes have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), any state securities laws or the securities laws of any other jurisdiction, and may not be offered or sold in the United States, or for the benefit of U.S. persons, except pursuant to an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities or blue sky laws. Accordingly, the Notes are being offered in the United States only to persons reasonably believed to be "qualified institutional buyers," as that term is defined under Rule 144A of the Securities Act, or outside the United States to non-"U.S. persons" in accordance with Regulation S under the Securities Act.

A confidential offering memorandum for the Offering of the Notes has been made available to such eligible persons. The Offering is being conducted in accordance with the terms and subject to the conditions set forth in such confidential offering memorandum.

This news release does not constitute an offer to sell or purchase, or a solicitation of an offer to sell or purchase, the Notes or any other security. No offer, solicitation, purchase or sale will be made in any jurisdiction in which such an offer, solicitation or sale would be unlawful.

Skyhawk Therapeutics Announces a Second Multi-Target Collaboration Agreement with Celgene to Discover and Develop Novel Small Molecules that Modulate RNA Splicing

On November 12, 2019 Skyhawk Therapeutics, Inc. (Skyhawk) reported that it has entered into a second global strategic collaboration with an affiliate of Celgene Corporation (NASDAQ: CELG) (Press release, Skyhawk Therapeutics, NOV 12, 2019, https://www.prnewswire.com/news-releases/skyhawk-therapeutics-announces-a-second-multi-target-collaboration-agreement-with-celgene-to-discover-and-develop-novel-small-molecules-that-modulate-rna-splicing-300956283.html [SID1234551025]). This new agreement follows the June 2018 collaboration between the two companies and focuses on targets relevant to the field of autoimmune disorders, oncology, and immuno-oncology, providing further validation of Skyhawk’s proprietary SkySTARTM technology platform. The scope of the collaboration allows the parties to systematically interrogate a range of targets that have been clinically validated or are highly associated with the genetic basis of disease but have been considered undruggable using conventional small molecule therapies.

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Under the collaboration agreement, Skyhawk grants Celgene options to exclusively license worldwide intellectual property rights to candidates discovered and developed under the collaboration that are directed to program targets. Following Celgene’s exercise of its option, Celgene will be responsible for further development and commercialization.

"Our impressive progress to date on targets that are part of our 2018 collaboration has led Celgene to enter into this new agreement focused on challenging targets beyond neurology," said Bill Haney, co-founder and CEO of Skyhawk Therapeutics. "This provides further evidence of the ability of our SkySTARTM technology platform to rapidly identify druggable sites and unique chemical matter to correct mRNA mis-splicing that may result in new treatment options for patients. We look forward to the advancement of programs under this new collaboration and the potential to bring new treatment options to patients with unmet medical needs."

"The Skyhawk team’s rapid and substantive progress demonstrates to us the unique advantages of the SkySTARTM platform and led us to expand our relationship. We see Skyhawk’s platform as a key disruptive technology that will support the autoimmune, oncology and immuno-oncology pipelines of the company we are today, and the company we are planning to be," said Rupert Vessey, M.A., B.M., B.Ch., F.R.C.P., D.Phil., President, Research & Early Development, Celgene Corporation."

Sorrento CEO to Present at Upcoming Investor Conferences

On November 12, 2019 Sorrento Therapeutics, Inc. (NASDAQ: SRNE, "Sorrento"), reported that Dr. Henry Ji, Chairman and CEO, will participate in upcoming investor conferences in the 4th quarter 2019 (Press release, Sorrento Therapeutics, NOV 12, 2019, View Source [SID1234551041]). Dr. Ji will provide a corporate overview and business update focusing on the clinical pipeline progress for Sorrento Therapeutics immuno-oncology and pain programs.

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Stifel 2019 Healthcare Conference

Date: Wednesday, November 20, 2019
Presenter: Dr. Henry Ji
Time: 9:45 AM Eastern Time
Location: Lotte New York Palace Hotel, NY

Evercore ISI 2nd Annual HealthCONx Conference

Date: Tuesday, December 3, 2019
Presenter: Dr. Henry Ji
Time: 12:30 PM Eastern Time
Location: Four Seasons Hotel, Boston, MA

Allakos Reports Third Quarter 2019 Financial Results

On November 12, 2019 Allakos Inc. (the "Company") (Nasdaq: ALLK), a biotechnology company developing antolimab (AK002) for the treatment of eosinophil and mast cell related diseases, reported financial results for the third quarter ended September 30, 2019 (Press release, Allakos, NOV 12, 2019, View Source [SID1234553324]).

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Third Quarter 2019 Financial Results

Research and development expenses were $16.1 million in the third quarter of 2019 as compared to $8.7 million in the same period in 2018. The increase in research and development expenses was primarily related to an increase in contract research and development activities in support of the advancement of antolimab (AK002), the Company’s lead antibody, as well as an increase in consulting and personnel-related costs.

General and administrative expenses were $7.5 million in the third quarter of 2019 as compared to $3.3 million in the same period in 2018. The increase in general and administrative expenses was primarily attributable to an increase in personnel-related costs as a result of the Company’s increase in employee headcount. Other period-over-period changes included increases to legal costs, accounting and audit service fees, and public company directors and officers liability insurance premiums.

Allakos reported a net loss of $21.7 million in the third quarter of 2019 as compared to $11.1 million in the same period in 2018, an increase of $10.6 million. Net loss per basic and diluted share was $0.47 for the third quarter of 2019 compared to $0.34 in the same period in 2018.

Allakos ended the third quarter of 2019 with $517.0 million in cash, cash equivalents and marketable securities.

Evotec SE reports first nine-month 2019 results and corporate updates

On November 12, 2019 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported financial results and corporate updates for the first nine months ended 30 September 2019 (Press release, Evotec, NOV 12, 2019, View Source;announcements/press-releases/p/evotec-se-reports-first-nine-month-2019-results-and-corporate-updates-5864 [SID1234550887]).

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OPERATIONAL PERFORMANCE – DRIVING DRUG DISCOVERY AND DEVELOPMENT FAST FORWARD
Multiple new alliances in EVT Innovate and EVT Execute
Just – Evotec Biologics off to a very good start
Achievement of multiple important milestones (e.g. Bayer, Boehringer Ingelheim, Celgene, Indivumed)
Co-owned pipeline projects progressing very well, e.g. with positive Phase II POC results in chronic cough with Bayer
Extension of iPSC-based neurodegeneration partnership with Celgene into 2023; triggering additional $ 30 m payment
Joint venture created with Vifor Pharma focused on novel nephrology therapeutics (after period-end)
Expansion of BRIDGE roll-out with new BRIDGEs LAB10x and LAB555 (after period-end)
Continued company formations and equity participation e.g. in Aeovian, Eternygen, Facio, Immunitas; and spin-off formation Breakpoint Therapeutics GmbH focused on DNA damage response
Building a leading position in anti-infectives discovery and development (e.g. alliances with GARDP, GNA Now, Helmholtz, and the Bill & Melinda Gates Foundation)

INCREASE IN EBITDA GUIDANCE FOR FULL-YEAR 2019
Full-year 2019 guidance for revenue and unpartnered R&D costs confirmed; EBITDA guidance increased to approximately 15% (previously: >10%)

FINANCIAL PERFORMANCE
In the first nine months of 2019, Evotec’s Group revenues continued their strong performance and increased by 16% to € 321.4 m (9M 2018: € 278.1 m). This positive development is mainly due to the very strong performance in the base business across all business lines, solid milestone payments, and first revenue contributions by Just – Evotec Biologics (€ 10.4 m). Revenues from milestones upfronts and licences, which can vary significantly from quarter to quarter, decreased to € 22.3 m in comparison to the previous year (9M 2018: € 27.2 m) and included, amongst others, payments from Bayer, Boehringer Ingelheim, and Celgene.

The gross margin in the first nine months of 2019 amounted to 30.7% (9M 2018: 30.1%). This increase in margin compared to 2018 is based on very good capacity utilisation and favourable FX.

In the first nine months of 2019, Evotec focused its unpartnered R&D expenses of € 25.7 m primarily on initiatives in the fields of metabolic diseases, oncology, and platform projects. Its partnered R&D expenses of € 15.6 m on its infectious disease portfolio were shown under R&D while the expenses fully reimbursed by its partner Sanofi were recognised under other operating income. This split into unpartnered and partnered R&D expenses had not been applied in the first nine months of 2018, where total R&D expenses of € 16.0 m were recorded compared to total € 41.3 m in the reporting period.

The Group’s selling, general and administrative ("SG&A") expenses increased by 13% to € 46.2 m (9M 2018: € 40.8 m) in the first nine months of 2019. This increase is mainly due to overall company growth including staff increases, upgrading of systems, consultancy fees, plus expenses from acquired companies, equity and financing transactions.

Impairments of intangible assets and goodwill of € 11.9 m were recorded (9M 2018: impairment of intangible assets of € 4.2 m). This one-off impairment was mainly due to the termination of the SGM-1019 agreement by our partner Second Genome, the programme was fully impaired (€ 10.3 m). This impairment of intangible assets in addition triggered a goodwill impairment of € 1.6 m of the cash-generating unit Evotec (US) Innovate. All rights of the underlying asset were returned to Evotec.

The strong increase in the adjusted Group EBITDA to € 93.2 m (9M 2018: € 68.7 m), resulted mainly from the very strong performance in the base business, solid milestones and licence contributions, a positive EBITDA contribution by Just – Evotec Biologics and effects from the first-time application of the new accounting standard IFRS 16 (+€ 10.1 m).

In the first nine months of 2019, Evotec’s operating result was € 46.4 m (9M 2018: € 59.5 m). A year on year comparison is not meaningful, as 2018 was significantly positively affected by a one-off impact from the bargain purchase ID Lyon in 2018 (€ 15.4 m). The Company’s net result for the first nine months of 2019 amounted to € 29.7 m (9M 2018: € 52.3 m) and also cannot be compared like for like as it was affected by the one-off effect of the impairments on intangible assets and goodwill.

Evotec ended the third quarter of 2019 with a strong liquidity position of € 282.6 m (31 December 2018: € 149.5 m), which was composed of cash and cash equivalents (€ 249.6 m) and investments (€ 33.0 m). In the first nine months of 2019, liquidity was primarily affected by the completion of the repayment of the remainder of the € 140 m debt bridge facility drawn down in context of the acquisition of Aptuit in August 2017 as well as the repayment of flexible bank loan agreements, the successful issue of a promissory note (Schuldschein) worth € 250 m, gross, at very attractive interest rates of below 1.5%, as well as the draw-down of another tranche of the European Investment Bank R&D loan and the acquisition of Just – Evotec Biologics.

OPERATIONAL PERFORMANCE
Overall, the EVT Execute segment continued its strong progress in existing alliances and signed new or extended established partnerships. The strong performance was highlighted through the signing of a strategic multi-year drug discovery collaboration across multiple therapeutic areas with Takeda. Evotec will use its leading integrated drug discovery platform to deliver clinical candidates for Takeda to pursue into clinical development. Evotec is eligible to receive pre-clinical, clinical, and commercial milestones that can total in excess of $ 170 m per programme as well as tiered royalties on future sales.

The Just – Evotec Biologics integration into the Evotec Group is fully on track. In the first three months since the acquisition, Just – Evotec Biologics signed new agreements e.g. with Teva and Biocon Biologics.

EVT Innovate continued to deliver strong progress within its collaborations, signed important new contracts and extensions plus achieved major advances in Evotec’s co-owned pipeline. Bayer achieved positive Phase II POC results with its P2X3 antagonist in chronic cough showing good efficacy and safety.

Evotec’s academic BRIDGE portfolio has been expanded through LAB555 (after period-end), the first BRIDGE built in Israel. The partnership aims to expedite drug discovery and development by providing efficient translation of early stage Hebrew University research.

Evotec continues to invest in promising companies with operational synergies. Evotec was participating in Aeovian’s series A financing after successfully delivering Aeovian’s first candidate drug, and formed its second spin-off Breakpoint Therapeutics, a virtual company focusing on the development of Evotec’s DNA damage response portfolio. Furthermore, Evotec invested in the NewCo Immunitas Therapeutics, a Boston-based monoclonal antibody company.

Furthermore, Evotec expanded its position, being at the forefront of women’s health and anti-infective drug discovery. Evotec entered an alliance with Celmatix, a partnership to develop pre-clinical programmes in prevalent but underserved conditions affecting women’s reproductive health, including polycystic ovary syndrome, endometriosis, and infertility.

In the field of anti-infectives, Evotec closed additional collaborations, e.g. kicking off "GNA Now", a new initiative for the development of novel antibacterial agents. The increasing recognition of antibiotic resistance as growing threat to public healthcare systems enabled Evotec to receive grants for projects to further accelerate drug discovery efforts in this area of high medical need.

After period-end, Evotec and Vifor Pharma launched a joint venture focused on the discovery and development of novel nephrology therapeutics. Both companies will hold a 50% share, with Vifor Pharma benefiting from access to an external R&D capability for the development of a Nephrology pipeline, while Evotec will gain access to a commercial partner for assets developed through the Joint Venture. The initial funding of € 25 m for pre-clinical development will be covered by Vifor Pharma, while Evotec contributes its PanHunter bioinformatics platform and high-quality data sets from thousands of human kidney disease patients to the Joint Venture.

INCREASE IN EBITDA GUIDANCE FOR FULL-YEAR 2019
Full-year 2019 guidance for revenue and unpartnered R&D costs confirmed; EBITDA guidance increased to approximately 15% (previously: >10%).

Webcast/Conference Call
The Company is going to hold a conference call to discuss the results as well as to provide an update on its performance. The conference call will be held in English.

Conference call details

Date: Tuesday, 12 November 2019

Time: 02.00 pm CET (08.00 am EST, 01.00 pm GMT)