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SEC Company Response from AC Immune SA (ACIU) (CIK 0001651625) (ACIU) — Jan 17, 2020

AC Immune SA (ACIU) (CIK 0001651625)
Date: Jan. 17, 2020 · CIK: 0001651625 · Accession: 0000950103-20-000800

AI Filing Summary & Sentiment

Referenced dates: January 6, 2020

Date
January 17, 2020
Author
/s/ Joerg Hornstein
Form
CORRESP
Company
AC Immune SA (ACIU) (CIK 0001651625)

Letter

Division of Corporation Finance Office of Life Sciences 100 F Street N.E. Washington, D.C. 20549-4628

Re: AC Immune SA

Dear Ms. Ignat and Mr. Wyman,

On behalf of AC Immune SA (the “Company” or “AC Immune”), I am responding to the comment from the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) in the Staff’s letter dated January 6, 2020 relating to the Company’s financial statements and disclosure in the Company’s Form 6-K dated August 14, 2019.

Set forth below are the Company’s responses to the Staff’s comment. For convenience, the Staff’s comment is repeated below in italics, followed by the Company’s response to the comment.

Form 6-K dated August 14, 2019

Exhibit 99.1

Interim Condensed Financial Statements (unaudited)

Notes to Interim Condensed Financial Statements

3.1 Licensing and collaboration agreements, page 13

Please revise your disclosure to include the significant judgments underlying your conclusion that the

license granted to Lilly was distinct and represented a right-to-use, as addressed in IFRS 15.123 and 125. In this regard, consider providing certain information on pages 2-5 of your response, as follows:

· The nature of the license granted to Lilly with regard to its ongoing development and future commercialization activities,

· The degree to which the Pre-clinical and Phase 1 development activities conducted by you “do not represent integrated services with the licensed IP” to Lilly and the absence of any impact of your R&D activities on the "form or functionality of the underlying IP" licensed to Lilly,

· The purpose of Pre-clinical and Phase 1 development activities conducted by Lilly and the absence of any linkage between these activities and your development activities, other than through the joint steering committee and

· The nature and frequency of the information-sharing process through the joint steering committee and how this process is expected to impact the future development activities to be independently conducted by you and Lilly.

Company response:

The Company acknowledges the Staff’s comment and notes in response to this comment that it currently intends to include the disclosure substantially in the form set forth in Exhibit A to this response letter in its upcoming annual report on Form 20-F for the fiscal year ended December 31, 2019 (but that this disclosure remains subject to completion of the company’s internal procedures to finalize its upcoming annual report on Form 20-F).

To the extent you have any questions regarding the response contained in this letter, please do not hesitate to contact me at +41 21 345 91 37 or joerg.hornstein@acimmune.com. Thank you for your time and attention.

Very truly yours,
/s/ Joerg Hornstein

Show Raw Text
CORRESP
1
filename1.htm

EPFL Innovation Park- Bldg B

1015 Lausanne, Switzerland

January 17, 2020

 Re: AC Immune SA

Form 20-F for the Fiscal Year Ended December
31, 2018

Filed April 19, 2019

Form 6-K for the Quarterly Period Ended
June 30, 2019

Filed August 14, 2019

File No. 001 - 37891

Ms. Ibolya Ignat

Mr. Franklin Wyman

U.S. Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

100 F Street N.E.

Washington, D.C. 20549-4628

Dear Ms. Ignat and Mr. Wyman,

On behalf of AC Immune SA (the “Company”
or “AC Immune”), I am responding to the comment from the Staff (the “Staff”) of the Securities and Exchange
Commission (the “Commission”) in the Staff’s letter dated January 6, 2020 relating to the Company’s financial
statements and disclosure in the Company’s Form 6-K dated August 14, 2019.

Set forth below are the Company’s responses
to the Staff’s comment. For convenience, the Staff’s comment is repeated below in italics, followed by the Company’s
response to the comment.

Form 6-K dated August 14, 2019

Exhibit 99.1

Interim Condensed Financial Statements (unaudited)

Notes to Interim Condensed Financial Statements

3.1 Licensing and collaboration agreements, page 13

Please revise your disclosure to include the significant judgments
underlying your conclusion that the

license granted to Lilly was distinct and represented a right-to-use,
as addressed in IFRS 15.123 and 125. In this regard, consider providing certain information on pages 2-5 of your response, as follows:

 · The
nature of the license granted to Lilly with regard to its ongoing development and future commercialization activities,

 · The
degree to which the Pre-clinical and Phase 1 development activities conducted by you “do not represent integrated services
with the licensed IP” to Lilly and the absence of any impact of your R&D activities on the "form or functionality
of the underlying IP" licensed to Lilly,

 · The
purpose of Pre-clinical and Phase 1 development activities conducted by Lilly and the absence of any linkage between these activities
and your development activities, other than through the joint steering committee and

 · The
nature and frequency of the information-sharing process through the joint steering committee and how this process is expected
to impact the future development activities to be independently conducted by you and Lilly.

Company response:

The Company acknowledges the Staff’s comment and notes
in response to this comment that it currently intends to include the disclosure substantially in the form set forth in Exhibit
A to this response letter in its upcoming annual report on Form 20-F for the fiscal year ended December 31, 2019 (but that this
disclosure remains subject to completion of the company’s internal procedures to finalize its upcoming annual report on Form
20-F).

To the extent you have any questions regarding the response contained
in this letter, please do not hesitate to contact me at +41 21 345 91 37 or joerg.hornstein@acimmune.com.
Thank you for your time and attention.

Very truly yours,

/s/ Joerg Hornstein

Joerg Hornstein

Chief Financial Officer

Exhibit A

Tau Morphomer Small Molecule – 2018 license
agreement with Eli Lilly and Company

In December 2018, we entered into an exclusive,
worldwide licensing agreement with Eli Lilly and Company (“Lilly”) to research and develop Tau Morphomer small molecules
for the treatment of Alzheimer’s disease and other neurodegenerative diseases. More specifically, this is an exclusive license
with the right to grant sublicenses, under the ACIU Patents, the ACIU Know-How, and ACIU’s interests in the Joint Patents
and the Joint Know-How to Exploit the Licensed Compounds and Licensed Products The agreement became effective on January 23, 2019
when the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, expired. On September 19, 2019,
the Company and Lilly entered into an amendment to divide the first discretionary milestone payment under the agreement of CHF
60 million into two installments with the first CHF 30 million paid in Q3 2019 and the second CHF 30 million to be paid on or before
March 31, 2020 unless Lilly earlier terminates the agreement.

Per the terms of the agreement, the Company
received an initial upfront payment of CHF 80 million in February 2019 for the rights granted by the Company to Lilly. The Company
is conducting the development of ACI-3024, our lead candidate from our Tau Morphomer small molecules program through the completion
of Phase 1, which commenced in the first half of 2019. Lilly will lead and fund further clinical development and will retain global
commercialization rights for all indications, including Alzheimer’s disease, Progressive Supranuclear Palsy and other neurodegenerative
diseases. As it relates to our lead compound, ACI-3024, Lilly will lead development after the completion of Phase 1 and retain
commercialization rights. As of December 31, 2019, Lilly is engaged in certain Pre-clinical activities of its own as defined in
the agreement, which are intended to provide further data in support of the Phase 2 clinical study design.

Per the terms of the agreement, the Company
may become eligible to receive additional milestone payments totaling up to approximately CHF 840 million for clinical and regulatory
milestones and CHF 900 million upon achievement of certain commercial milestones. In addition to milestones, we will be eligible
to receive royalties on sales at a percentage rate ranging from the low-double digits to the mid-teens. The agreement will terminate
by the date of expiration of the last royalty term for the last licensed product. However, under the terms of the agreement, Lilly
may terminate the agreement at any time after March 31, 2020 by providing three months’ notice to us.

AC Immune assessed this arrangement in accordance
with IFRS 15 and concluded that Lilly is a customer. The Company identified the following significant performance obligations under
the contract: (i) a right-of-use license and (ii) research and development activities outlined in the development plan. Per the
agreement, the Company is responsible for the pre-clinical and Phase 1 activities, which the Company determined are distinct and
capable of being completed by Lilly or a third party. Pre-clinical activities for which AC Immune was responsible prior to their
completion in May 2019 included final manufacturing of materials for use in the Phase 1 and regulatory submission of the protocols.
For the current Phase 1, AC Immune is responsible for leading the study design, obtaining relevant regulatory agency approvals,
arranging necessary third party contracts, completing patient selection, ensuring patient treatment, following up with patients,
drafting the clinical study report development and other relevant clinical activities to ensure that the primary objective of the
study is completed. The Company used CMOs for certain of its pre-clinical activities and is currently using CROs to complete certain
Phase 1 activities.

The Company’s pre-clinical and Phase
1 activities do not represent integrated services with the licensed IP for which Lilly contracted. Lilly purchased a license to
the Company’s Tau therapeutic small molecule program, which was delivered at commencement of the agreement and AC Immune’s
pre-clinical and Phase 1 activities do not affect the form or functionality of this license. The Company’s objective of the
current Phase 1 activity is to assess safety and tolerability and does not modify or customize the lead compound and the completion
of these pre-clinical and Phase 1 activities does not affect the licensed IP.

Finally, per the agreement, each party has
three representatives in a joint steering committee (“JSC”); depending upon the agenda, additional field experts can
attend the JSC to provide the technical and scientific contribution required. The JSC meets on a regular basis depending on agreements
between the representatives. The JSC is responsible for (i) serving as the forum to discuss, review and approve certain activities
by reviewing and discussing the development progress and updates to make, (ii) discuss, review and approve all amendments to the
global development plan, (iii) periodically serve as forum to discuss and review commercialization of licensed products and (iv)
review and approve reports related to development costs among other activities. The JSC is intended to ensure that communication
between the parties remains consistent and that the development plan is both agreed to and progressing as intended.

The valuation of each performance obligation
involves estimates and assumptions with revenue recognition timing to be determined either by delivery or the provision of services.

The Company used the residual approach to
estimate the selling price for the right-of-use license and an expected cost plus margin approach for estimating the research and
development activities. The right-of-use license was delivered on the effective date. The research and development activities are
expected to be delivered over time as the services are performed. For these services, revenue will be recognized over time using
the input method, based on costs incurred to perform the services, since the level of costs incurred over time is thought to best
reflect the transfer of services to Lilly. The Company determined the value of the research and development activities to be CHF
6.9 million and deferred this balance from the effective date. As of December 31, 2019, the Company has recognized CHF XY million
in revenue, resulting in a deferred income (contract liability) balance of CHF XY million of which CHF XY million is classified
as non-current. The remaining CHF 73.1 million from the upfront payment was allocated to the right-of-use license and recognized
on the effective date.

At inception of the agreement, none of the
clinical, regulatory or commercial milestones had been included in the transaction price, as all milestone amounts were fully constrained.
As acknowledged in the amendment completed between the Company and Lilly in Q3 2019, the Company earned and received a CHF 30 million
milestone payment related to the right-of-use license for IP. The Company recognized contract revenues in Q3 2019 as there were
no further constraints related to this milestone. In assessing that future clinical, regulatory or commercial milestones are fully
constrained, the Company considered numerous factors to determine that these milestones are not highly probable to obtain, including
that receipt of the milestones is outside the control of the Company and contingent upon success in future clinical trials and
the licensee’s efforts. Any consideration related to sales-based milestones (including royalties) will be recognized when
the related sales occur as they were determined to relate predominantly to the license granted to Lilly and therefore have also
been excluded from the transaction price. The Company will re-evaluate the transaction price in each reporting period and as uncertain
events are resolved or other changes in circumstances occur.