Finance

Santhera Secures CHF 45 Million in Funding and Broadcasts Preliminary First Half-Yr 2021 Monetary Outcomes

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN THE UNITED STATES OR ANY OTHER JURISDICTION IN WHICH IT WOULD BE UNLAWFUL TO DO SO.

Advert hoc announcement pursuant to Artwork. 53 LR

Santhera will maintain a convention name on Wednesday, September 22, 2021 at 14:00 CEST, 13:00 BST, 08:00 EDT. Particulars are on the finish of this assertion.

  • Present shareholders Idorsia, Highbridge and Waypoint Capital take part in fairness elevate

  • New funding secures present operations previous the NDA submitting within the U.S. for vamorolone in DMD

Pratteln, Switzerland, September 20, 2021 – Santhera Prescription drugs (SIX: SANN) publicizes a strengthening of its capital construction by way of an oversubscribed fairness financing of CHF 20 million, a placement of personal convertible bonds of CHF 15 million and upsizing of an present financing association of as much as CHF 10 million. The brand new funding safes present operations to mid2022, previous the NDA submitting deliberate for Q1-2022, and permits for the reimbursement of the convertible bond maturing in February 2022.

“We’re very happy to have secured funding for our present operations effectively previous a key upcoming inflection level, particularly the submitting of a brand new drug software (NDA) for vamorolone in DMD with the U.S. Meals and Drug Administration (FDA) on the again of the profitable outcomes from the pivotal VISION-DMD research. On the identical time, this combined equity-debt financing minimizes dilution for present shareholders and permits enough capital for the reimbursement of the bonds due in February 2022,” stated Dario Eklund, Chief Govt Officer of Santhera. “We imagine that this financing, doubtlessly augmented by different non-dilutive sources of funds, will allow us to advance this necessary drug candidate nearer to market. I thank present and new buyers for his or her engagement and assist.”

NEW FUNDING SUPPORTS CURRENT OPERATIONS BEYOND NDA SUBMISSION FOR VAMOROLONE

Santhera has entered into financing commitments within the gross quantity of CHF 45 million, aimed toward strengthening its capital construction and satisfying its liquidity wants till mid-2022, previous the submitting of the NDA within the U.S. for vamorolone in DMD deliberate for Q1-2022.

H.C. Wainwright & Co. is performing because the unique placement agent for the financing. Octavian acted as an advisor to the Firm.

Fairness financing via the private placement of AGM-authorized shares
Santhera’s present buyers Idorsia, sure funds managed by Highbridge Capital Administration LLC (“Highbridge”) and Waypoint Capital and various new US and different worldwide institutional buyers have been allotted Santhera shares within the combination gross quantity of CHF 20 million in a non-public placement, on the exclusion of present shareholders’ pre-emptive rights. This consists of CHF 2 million of non-binding commitments anticipated to be happy within the quick time period. The position value has been set at CHF 1.60 per share. Santhera plans to supply the shares in complete or partly from the extraordinary capital improve as accredited by Santhera’s shareholders on June 22, 2021. As well as, every investor will obtain one warrant per two shares subscribed, every of which is exercisable for one Santhera share at an train value of CHF 2.00 at any time upon issuance for a interval of 5 years. Santhera expects to finish the capital improve and to announce the precise variety of shares issued inside the subsequent few days.

Placement of private convertible bonds to redeem convertible bond (SAN17) due in February 2022
Santhera will situation senior unsecured non-public convertible bonds with an combination principal quantity of CHF 15 million to Highbridge (the Non-public Convertible Bonds). The Non-public Convertible Bonds may be transformed by Highbridge into Santhera shares at a conversion value of CHF 1.76, implying a ten% premium on the difficulty value of the Santhera shares within the non-public placement. The ground value of the brand new convertible bonds for functions of curiosity funds in shares will probably be CHF 1.25. In any other case, the Non-public Convertible Bonds can have considerably the identical phrases as Santhera’s present Senior Unsecured Convertible Bonds due 2024, that are listed on the SIX Swiss Trade (ticker: SAN21, ISIN CH0563348744, the 2021/24 Bonds). The Non-public Convertible Bonds can have the identical maturity because the 2021/24 Bonds, particularly August 17, 2024, topic to early conversion, redemption or repurchase. Santhera has agreed to make use of the web proceeds from the Non-public Convertible Bonds to redeem its Senior Unsecured Convertible Bond 2021 (ticker: SAN17, ISIN CH0353955195), whose excellent principal quantity of CHF 15,155,000 will turn into due for redemption, along with accrued curiosity, in February 2022.

Upsized financing by Highbridge to fulfill quick time period liquidity wants
Highbridge has dedicated to extend its present financing association with Santhera to supply as much as CHF 10 million in new senior secured exchangeable notes. Such a facility permits for periodic drawdowns (based mostly on assembly sure standards, an evaluation of liquidity and different sources of funds, and enough shares for exchanges obtainable on the time) and may be exchanged by Highbridge for shares at a reduction to VWAP (volume-weighted common value) with a minimal trade value of a minimum of CHF 2. A primary tranche of CHF 2 million could also be drawn at closing, topic to sure drawdown situations. An extra tranche of CHF 5 million could also be drawn if and when the FDA helps an NDA for vamorolone in DMD in the USA upon which a CHF 5 million milestone fee to licensor ReveraGen turns into due. Subsequent drawdowns will probably be topic to milestones but to be agreed. The maturity of those new exchangeable notes will probably be Could 2024. As with the earlier exchangeable notes, the brand new exchangeable notes pays a hard and fast curiosity, which Santhera will pay in money at a price of 12% each year or in variety at a price of 13% each year.

As consideration for its financing commitments relating to the Non-public Convertible Bonds and the exchangeable notes, Santhera has issued to Highbridge an combination of two.5 million warrants, every of which is exercisable for one Santhera share at an train value of CHF 2.00 at any time upon issuance for a interval of 5 years.

FUNDING OUTLOOK AND UPCOMING MILESTONES

Considering the estimated web proceeds of the agreed funding of roughly CHF 42 million, Santhera at present expects to have enough liquidity till mid-2022. Santhera is on observe to fulfill key near-term inflection factors which, if profitable, will allow Santhera to hunt further financing after a unprecedented common assembly of shareholders to approve further share capital.

Key upcoming milestones:

PRELIMINARY UNAUDITED FINANCIAL RESULTS FOR THE SIX MONTHS ENDED JUNE 30, 2021

Complete income for the six months ended June 30, 2021, amounted CHF 4.4 million (Jan-Jun 2020: CHF 7.7 million). The lower in revenues is principally attributable to a CHF 2.0 million adjustment to defer revenues recorded within the first half-year 2021 attributable to uncertainties round pricing and reimbursement in France, in addition to an settlement with the regulatory authorities in France to provide Raxone freed from cost from August 2021 whereas reimbursement discussions are ongoing. Working bills of CHF 22.4 million (Jan-Jun 2020: CHF 31.9 million) have been 30% decrease attributable to lowered bills for growth, advertising and marketing and gross sales, and common administrative functions following the termination of the Puldysa program and the following restructuring. Through the interval, the Firm recorded monetary earnings of CHF 13.4 million in relation to the partial trade of the 2017/22 convertible bonds. For the six months ended June 30, 2021, the Firm recorded a web lack of CHF 19.7 million in comparison with CHF 31.8 million for the six months ended June 30, 2020.

As of June 30, 2021, the Firm had money and money equivalents of CHF 8.0 million in comparison with CHF 12.4 million as of December 31, 2020. Along with the funding introduced at present, of CHF 45 million gross or web roughly CHF 42 million after bills, the Firm expects to have enough liquidity in the direction of supporting working actions, together with milestones payable to ReveraGen and reimbursement of the remaining 2017/22 convertible bonds maturing in February 2022.

As of June 30, 2021, the Firm had convertible bonds excellent within the quantity of CHF 34.6 million of which CHF 15.1 million are due for reimbursement in February 2022, with the rest maturing in August 2024 until transformed earlier. The present debt excellent of CHF 12.0 million (as of June 30, 2021) within the type of exchangeable notes has been settled subsequent to the interval finish.

Complete consolidated fairness as of June 30, 2021 amounted to CHF 9.6 million in comparison with a web fairness deficit of CHF 6.3 million as of December 31, 2020.

In CHF hundreds

Jan-Jun 2021
(preliminary
unaudited figures)

Jan-Jun 2020
(unaudited)

Income from contracts with prospects

4,491

7,775

Working bills

-22,408

-31,911

Working end result

-19,588

-25,893

Internet end result

-19,768

-31,827

In CHF hundreds

Jun 30, 2021
(preliminary
unaudited figures)

Dec 31, 2020
(unaudited)

Money and money equivalents

7,991

12,411

Different present property

3,559

5,312

Noncurrent property

68,515

70,964

Complete property

80,065

88,687

Complete fairness

9,636

-6,354

Convertible bonds

34,602

57,875

Different noncurrent liabilities

7,457

8,097

Present exchangeable notes

12,061

10,595

Different present liabilities

16,309

18,474

Complete liabilities

70,429

95,041

Complete fairness and liabilities

80,065

88,687

The preliminary key monetary figures introduced on this press launch are topic to vary. The Firm plans to publish its full 2021 First Half-year Report, with an operational progress replace, throughout September 2021.

Convention Name
Santhera will host a convention name on September 22, 2021 at 14:00 CEST / 13:00 BST / 08:00 EDT the place CEO Dario Eklund and CFO Andrew Smith will focus on at present’s announcement. Members are invited to name one of many following numbers 10-Quarter-hour earlier than the beginning of the decision (no dial-in code is required):
Europe: +41 58 310 50 00
UK: +44 207 107 06 13
USA: +1 631 570 56 13

About Santhera
Santhera Prescription drugs (SIX: SANN) is a Swiss specialty pharmaceutical firm targeted on the event and commercialization of progressive medicines for uncommon neuromuscular and pulmonary ailments with excessive unmet medical want. Santhera has an unique license for all indications worldwide to vamorolone, a first-in-class dissociative steroid with novel mode of motion, which was investigated in a pivotal research in sufferers with DMD as a substitute for normal corticosteroids. The medical stage pipeline additionally consists of lonodelestat (POL6014) to deal with cystic fibrosis (CF) and different neutrophilic pulmonary ailments in addition to an exploratory gene remedy strategy focusing on congenital muscular dystrophies. Santhera out-licensed rights to its first accredited product, Raxone® (idebenone), outdoors North America and France for the therapy of Leber’s hereditary optic neuropathy (LHON) to Chiesi Group. For additional info, please go to www.santhera.com.

Raxone® is a trademark of Santhera Prescription drugs.

For additional info please contact:
public-relations@santhera.com or
Eva Kalias, Head Exterior Communications
Telephone: +41 79 875 27 80
eva.kalias@santhera.com

Disclaimer / Ahead-looking statements
This publication just isn’t meant to represent a suggestion or solicitation to buy or put money into securities of Santhera Prescription drugs Holding AG in any jurisdiction.
The securities referred to on this publication, together with in reference to the transaction described on this publication, is probably not publicly supplied, instantly or not directly, in Switzerland inside the which means of the Swiss Monetary Providers Act (“FinSA”). Neither this communication nor every other info materials regarding the securities referred to on this publication constitutes commercial inside the which means of the FinSA or a prospectus pursuant to the FinSA, and no such prospectus has been or will probably be ready for or in reference to the transaction described on this publication.
This publication doesn’t represent a suggestion to promote, or a solicitation of a suggestion to buy, any securities in the USA. The securities of Santhera Prescription drugs Holding AG to which these supplies relate haven’t been and won’t be registered underneath the USA Securities Act of 1933, as amended (the “Securities Act”), and is probably not supplied or bought in the USA absent registration or an relevant exemption from, or in a transaction not topic to, the registration necessities of the Securities Act. There won’t be a public providing of securities in the USA.
This publication could comprise sure forward-looking statements regarding Santhera Prescription drugs Holding AG and its enterprise. Such statements contain sure dangers, uncertainties and different components which might trigger the precise outcomes, monetary situation, efficiency or achievements of Santhera Prescription drugs Holding AG to be materially completely different from these expressed or implied by such statements. Readers ought to subsequently not place undue reliance on these statements, notably not in reference to any contract or funding choice. Santhera Prescription drugs Holding AG disclaims any obligation to replace these forward-looking statements.

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